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Last update 19 Aug 2025

Nalmefene Hydrochloride

Last update 19 Aug 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Intranasal nalmefene - Opiant Pharmaceuticals, nalmefene, Nalmefene hydrochloride dihydrate

+ [31]

Target

Opioid receptors

Action

antagonists

Mechanism

Opioid receptors antagonists(Opioid receptors antagonists)

Therapeutic Areas

Other DiseasesSkin and Musculoskeletal Diseases

Active Indication

AlcoholismOpiate OverdosePruritus+ [1]

Inactive Indication

GamblingSmoking Cessation

Originator Organization

Baxter International, Inc.

Active Organization

Tharimmune, Inc.

H. Lundbeck A/SIndivior, Inc.

+ [5]

Inactive Organization

Somaxon Pharmaceuticals, Inc.

Purdue Pharma LP

Opiant Pharmaceuticals, Inc.

+ [1]

License Organization

Biotie Therapies

Somaxon Pharmaceuticals, Inc.

H. Lundbeck A/S

+ [5]

Drug Highest PhaseApproved

First Approval Date

United States (17 Apr 1995),

Opiate Overdose

RegulationFast Track (United States), Priority Review (United States)

Structure/Sequence

Molecular FormulaC21H26ClNO3

InChIKeyGYWMRGWFQPSQLK-OPHZJPRHSA-N

CAS Registry58895-64-0

Clinical Trials associated with Nalmefene Hydrochloride

NCT06733519

/ Not yet recruitingPhase 2

Evaluation of TH104 for Moderate to Severe Pruritus in Primary Biliary Cholangitis: a Double-blind, Randomized, Placebo-controlled, Phase 2a Study

A phase 2a, multicenter, randomized, double-blind, placebo-controlled study of TH104 in primary biliary cholangitis (PBC) participants with moderate to severe pruritus.

Start Date01 Mar 2025

Sponsor / Collaborator

Tharimmune, Inc.

NCT06408714

/ WithdrawnPhase 3IIT

Comparison of Nalmefene Hydrochloride Injection and Naloxone Hydrochloride Injection for the Treatment of Recurrent Respiratory Depression After Suspected Acute Opioid Overdose in the Emergency Department

The goal of this clinical trial is to compare naloxone to nalmefene for the treatment of opioid overdose in adults. The main questions it aims to answer are:
* Does nalmefene lower the number of doses of medicine participants need to treat opioid overdose?
* When participants are given nalmefene instead of naloxone, do they have fewer complications of opioid overdose such as being admitted to the hospital or having a breathing tube inserted?
Researchers will compare nalmefene to naloxone for the treatment of opioid overdose. Nalmefene and naloxone are both approved medicines to treat opioid overdose.
Participants who are brought to the emergency department after an opioid overdose will be given a dose of either nalmefene or naloxone if their breathing slows down again after an opioid overdose. Participants will:
* Stay in the emergency department for 8 hours after receiving a dose of nalmefene or naloxone.
* Receive a phone call 7 days after their emergency department to check on how they are doing.
Background information:
Naloxone (also known as Narcan) and nalmefene are opioid blocking medicines. When someone overdoses on an opioid, such as heroin or fentanyl, their breathing slows down or stops and they can die. By giving naloxone or nalmefene, the effect of the opioid can be blocked and the person can start breathing again. Naloxone is the most commonly used medicine to reverse an opioid overdose. The effect of naloxone lasts about an hour, and patients may need more than one dose of naloxone to keep them breathing. Sometimes patients overdose, get a dose of naloxone and wake up, and then some time later their breathing slows down again and they need another dose of naloxone. This can happen because the effect of the opioid they took lasts longer than the effect of the naloxone.
The effect of nalmefene lasts longer than naloxone, about four hours. If a person gets nalmefene, their opioid may wear off before the nalmefene wears off and they might not need any more doses of a reversal medicine. Both naloxone and nalmefene are approved medicines for treating opioid overdose.
Often, when a person overdoses on an opioid, someone gives them naloxone right away and then they are brought to the emergency department. In the emergency department, they are watched for several hours to make sure they don't stop breathing again when their naloxone wears off. If they do stop breathing again, they are given another dose of naloxone. In this study, participants will be given either nalmefene or naloxone if their breathing slows down while they are in the emergency department.

Start Date26 Aug 2024

Sponsor / Collaborator

The University of New Mexico

ChiCTR2400088347

/ SuspendedPhase 4IIT

Application of different doses of nalmefene pre-injection in painless gastrointestinal enddoscopy

Start Date20 Aug 2024

Sponsor / Collaborator-

100 Clinical Results associated with Nalmefene Hydrochloride

100 Translational Medicine associated with Nalmefene Hydrochloride

100 Patents (Medical) associated with Nalmefene Hydrochloride

618

Literatures (Medical) associated with Nalmefene Hydrochloride

01 Nov 2025·NEUROPHARMACOLOGY

Reversal of a synthetic opioid overdose: Insights from a validated translational model

Article

Author: Purohit, Prasad ; de la Peña, Amparo ; Skolnick, Phil ; Laffont, Celine M

Synthetic opioids are linked to >90 % of opioid overdose deaths in the United States. A FDA's validated translational model of synthetic opioid overdose, expanded to include intranasal reversal agents, was used to compare the effectiveness of FDA-approved intranasal naloxone (4 mg) and intranasal nalmefene (3 mg nalmefene hydrochloride, 2.7 mg base). In the absence of intervention, simulations using various intravenous doses of fentanyl and carfentanil predicted an incidence of cardiac arrest ranging from 18 % to 90 % in chronic opioid users and from 40 % to 96 % in opioid naïve subjects. Across dosing scenarios, intranasal nalmefene produced large and clinically meaningful reductions in the incidence of cardiac arrest compared to intranasal naloxone; the greatest differences in effectiveness were manifested at the higher doses of synthetic opioids. In the original publication describing FDA's model, the reversal agent was administered 1 min after ventilation was reduced to 40 % of baseline. Introducing further delays in intervention reduced the effectiveness of both reversal agents. Simulations showed intranasal nalmefene reduced the incidence of cardiac arrest compared to intranasal naloxone when intervention was delayed 2.5-3 min; delays ≥7.5 min abolished the effectiveness of both agents. The model was also used to predict the duration of brain hypoxia following a synthetic opioid overdose in a typical chronic opioid user. Across those simulations, intranasal nalmefene was generally more effective than intranasal naloxone in reducing brain hypoxia duration. These findings illustrate both the relative effectiveness of nalmefene and naloxone in reversing a synthetic opioid overdose and the importance of rapid intervention.

09 Aug 2025·INTERNATIONAL JOURNAL OF DRUG POLICY

Stronger isn't always better: Nalmefene in community overdose response and the false promise of quick-fix public health solutions.

Article

Author: Fink, Lauren R ; Rieder, Travis N ; Navin, Mark C

The United States is in its third decade of a drug overdose crisis. An important tool for responding to this crisis is the opioid overdose reversal agent, naloxone. However, with hyper-potent opioids like fentanyl present in the drug supply, some have argued for alternative overdose reversal agents such as nalmefene, which has higher opioid receptor affinity and a longer half-life. This reasoning moves too quickly. There is little evidence that adopting nalmefene for community-based overdose response will provide overall benefit, and there are good reasons to expect that it will cause substantial harm. Nalmefene appears to promise a "magic bullet" solution to a complicated and terrible problem, but sustainable overdose prevention requires comprehensive improvements to public health infrastructure. The overdose crisis requires attention, effort, and funding more than it needs a novel technological or pharmaceutical intervention.

08 Aug 2025·ADDICTION

Effect modification in therapeutic impact of nalmefene on alcohol dependence by ADH1B polymorphism: A secondary analysis of a Japanese randomized clinical trial.

Article

Author: Kojima, Yoshitsugu ; Matsuo, Keitaro ; Takao, Soshi ; Hashimoto, Nozomu ; Nakamura, Izuru ; Okahisa, Yuko ; Sakamoto, Shinji ; Ikeda, Daisuke D ; Takaki, Manabu

BACKGROUND AND AIMS:

The association between alcohol-metabolizing enzyme polymorphisms and treatment response to nalmefene for alcohol dependence has not been studied. We aimed to determine whether alcohol-metabolizing enzyme polymorphisms, specifically ADH1B rs1229984 and ALDH2 rs671, modify the treatment response to nalmefene for alcohol dependence.

DESIGN:

Secondary analysis of a Japanese randomized clinical trial, in which participants were randomly assigned (4:3:4) to placebo, 10 mg nalmefene or 20 mg nalmefene groups for 24 weeks, accompanied by a brief psychosocial intervention.

SETTING:

80 addiction outpatient clinics across Japan.

PARTICIPANTS:

A subset of 531 individuals (mean age 49.2 years, standard deviation 11.5; 69.9% male), including 196 in the placebo group and 335 in the nalmefene group, who agreed to DNA preservation and had available DNA data between February 2015 and July 2016.

MEASUREMENTS:

Genotyping was performed to determine ADH1B rs1229984 polymorphism (AA, AG, GG) and ALDH2 rs671 polymorphism (GG, GA, AA) in participants. Primary endpoint was change from baseline in monthly heavy drinking days (HDD, days/month) over the 24 treatment weeks. The key secondary endpoint was change from baseline in daily total alcohol consumption (TAC, g/day) over the 24 treatment weeks.

FINDINGS:

A mixed-effects model for repeated measures analyses showed a statistically significant gene-treatment interaction with ADH1B rs1229984 for TAC [10.71 (95% confidence interval = 4.03-17.39) g/day, P = 0.002], but not for HDD [1.65 (-0.38 to 3.67) days/month, P = 0.110]: as the G allele of rs1229984 increased, the efficacy regarding TAC decreased. In contrast, no statistically significant gene-treatment interaction was seen with ALDH2 rs671 for either TAC [4.46 (-7.88 to 16.80) g/day, P = 0.478] or HDD [-0.91 (-4.60 to 2.78) days/month, P = 0.630]. In the ADH1B rs1229984 variant, the number needed to treat for two category shifts in drinking risk level, as defined by the World Health Organization, was 3.7 for AA carriers, 6.6 for AG carriers and 18.5 for GG carriers.

CONCLUSIONS:

The ADH1B rs1229984 polymorphism appears to moderate the response to nalmefene in Japanese patients with alcohol dependence. Specifically, nalmefene appears to show efficacy in individuals with the ADH1B rs1229984 AA genotype.

102

News (Medical) associated with Nalmefene Hydrochloride

01 Aug 2025

·endpoints.news

FDA requires opioid label updates to highlight long-term risks

The FDA on Thursday required new safety label updates for all opioids to “further emphasize and characterize the risks associated with long-term use,” following a May advisory committee meeting that discussed new postmarketing data. Specifically, the FDA told companies to pull the phrase “extended treatment period” in the Indications and Usage section of their labels, “to avoid misinterpretation that there are data to support safety and efficacy of opioid analgesics over an indefinitely long duration.” The updates also clarify that extended-release/long-acting opioids “should only be used” when alternatives, such as immediate-release opioids, “are inadequate to manage severe and persistent pain, and to emphasize the importance of avoiding rapid dose reduction or abrupt discontinuation in patients who may be physically dependent on opioid pain medicines,” the agency said in the update . In May, panelists on an FDA advisory committee offered mixed takes on whether the agency should update opioid labels with data from two required postmarketing studies. Some panelists found the studies’ findings difficult to interpret and not generalizable to current medical practice, since they were several years old. The FDA opted to add that information to the labels, which shows that over a 12-month period, approximately 1% to 6% of participants across the two postmarket groups newly met the criteria for addiction, and about 9% to 22% of participants newly met criteria for prescription opioid abuse and misuse. The FDA first approved extended-release/long-acting opioids in 1987. In 2013, it sought five additional postmarketing studies after concluding that more data were needed regarding the serious risks of misuse, abuse, addiction, overdose and death associated with long-term use. Allergan, Endo Pharmaceuticals, Hikma, Janssen, Mallinckrodt, Pfizer and Purdue Pharma were among those tasked with conducting the four observational studies and one prospective clinical trial. The agency also said it’s requiring label updates on which opioid overdose reversal agents are currently available. The FDA in March 2023 approved the first over-the-counter nasal spray version of naloxone, and in August 2024, FDA approved the first nalmefene hydrochloride auto-injector to treat opioid overdose in adults and children 12 years and older. Manufacturers must further “emphasize that higher doses are associated with increased risk of serious harm, and that the risks of serious harms persist over the course of therapy,” the FDA said.

Drug Approval

10 Jul 2025

·orexo.com

Shaping the Future of Drug Delivery: Orexo’s AmorphOX® Unlocks New Possibilities for Critical Medicines

Formulating therapeutics as powders offers significant advantages over liquids, particularly for stabilizing fragile compounds that degrade under varying environmental conditions. This approach enhances molecular stability, extends shelf life, and eliminates the need for cold chain logistics. Orexo has emerged as a leader in the intranasal delivery of powder-based medications thanks to its proprietary AmorphOX technology. To learn more about powder-based drugs, their transformative qualities, the advantages of intranasal delivery, and the characteristics of AmorphOX, we spoke with Orexo's Senior Vice President and Head of Research and Development, Robert Rönn. What is powder-based formulation technology? Formulating powder-based products involves converting active pharmaceutical ingredients into fine, dry particles that can for example be delivered by inhalation or intranasally. In practice, this can be done by either spray drying or freeze drying using specific stabilizing excipients. Unlike traditional nasal liquid spray formulations, powders may not require preservatives, reducing formulation complexity and making them purer for patients. Nasal drug-delivery enables rapid absorption through the mucosal membranes, offering a non-invasive, needle-free alternative to injections. The fast absorption makes nasal products ideal for emergency treatments and therapies requiring immediate effect. What are the transformative aspects of powder-based formulation technologies? Powder-based formulation technologies have clear advantages over traditional liquid-based systems. One of the most critical benefits is thermal stability, allowing medicines to withstand fluctuating temperatures without degradation. This eliminates reliance on cold chain logistics, simplifying global distribution and making it far easier to reach patients in remote or resource-limited settings. Powder formulations may also extend shelf life and preserve therapeutic efficacy over time, which is especially crucial for sensitive compounds including vaccines, biologics, and emergency medicines such as epinephrine. In addition, the dry format reduces the risk of microbial contamination and improves handling flexibility. These qualities make powder-based delivery especially well-suited for mass deployment in emergency or pandemic scenarios. While the advantages are compelling, the transition to powder formats comes with its own set of challenges, particularly around scalability and advanced manufacturing techniques. At Orexo, we have invested in manufacturing technologies and partnerships to ensure robust, scalable production of powder-based products for nasal delivery. We need to ensure that the benefits of these drugs can be realized at a global scale. Could you elaborate on how AmorphOX® was developed? It all started with the development of OX124, our nasal naloxone rescue medication, formulated to save the lives of people experiencing overdoses caused by powerful synthetic opioids. We knew that developing a liquid spray would probably be simpler, but we could see the potential and benefits of using a nasal powder instead. We started by evaluating different concepts of formulating a dry powder and after thorough assessment, we decided to proceed with a monoparticulate powder – we wanted to bring all the materials needed for each product into a single particle. Monoparticulate powders overcome one of the biggest challenges with more traditional dry powder blends, which is that particles of various sizes separate and can cause manufacturing issues. With AmorphOX, we dissolve all the materials into a solution and then spray dry the product to create a monoparticulate powder. Spray drying is an established, scalable manufacturing process. It’s taken us 8 years of research, during which time we’ve experimented with the AmorphOX technology across more than 500 formulations, using more than 20 different molecules and conducted 5 successful clinical studies. All this knowledge features in our researchers´ daily work as we apply AmorphOX to new molecules and explore different therapeutic areas. What challenges have you experienced during your research? A key challenge we faced was to identify suitable excipients and the appropriate combination with different active ingredients. This contributes to critical attributes of the powder, such as chemical and physical stability, dissolution speed and ultimately pharmacokinetic properties once delivered to patients. It's taken us time to work through the spray-drying process to produce a powder with the desired properties, such as a controlled particle size. This is especially important when you want to administer the powder in the nose and know that it will stay there and not go into the lungs. We’re delighted to have established a robust manufacturing process, even at commercial scale, through our significant investments into research and development.2 Another challenge we have faced during the development has been to protect the powder from coming into contact with moisture, which we’ve achieved through the development of a robust secondary packaging. Regulatory processes for novel, groundbreaking formulation technologies are complex, particularly when it comes to emergency use combination products that integrate both a drug and a device. In the development of OX124, which is currently in the regulatory review phase with the FDA, we’ve had to learn the hard way about all the governance and manufacturing requirements that are needed for approval. It’s something we take seriously as ultimately it's to protect the safety of patients and prescribers. What makes AmorphOX® powder technology innovative? Superior stability is the most significant advancement over liquid-based products. During research, we saw very early on in our data that the powder form improves the stability of small molecules. We’ve researched this extensively, testing different formulations and APIs, including large, biologically sensitive molecules, for example proteins and vaccines. To put this into perspective, proteins and vaccines in liquid form are often stored at -80 degrees centigrade and need to be kept under cold conditions at every step of the supply chain, but when combined with AmorphOX in a powder form, this requirement disappears. For OX640, our adrenaline product in the clinical development phase, the stability and dose conformity are outstanding compared to today´s standard treatments. The amount of the drug in a typical autoinjector product actually reduces as it moves closer to the expiry date. When it’s first issued, there’s around 115% of 0.3mgs epinephrine available, and by the time it goes out of date, it may be around 80%, which is only 0.24mgs. With OX640, our nasal epinephrine product, the dose starts at 2mgs and remains at 2mgs for the duration of the product lifecycle because it has better stability and dose conformity.3 We have recently successfully completed an in-vivo proof-of-concept study of a vaccine in partnership with Abera Bioscience. The data demonstrates the potential of AmorphOX for the development of powder-based vaccines with transformative benefits for patients, clinicians and healthcare systems globally.4 What are the advantages of nasal administration? Perhaps the most significant advantage for many patients is that it’s needle-free. Not only does this make it a more comfortable option, it also gives patients with needle-phobia an alternative treatment choice. Needle fear is widespread and associated with avoidance behaviours, even where the injection is needed to treat a severe medical condition.5 For vaccines, which are commonly administered through injections by a healthcare professional in a clinical setting, powder-based nasal products could be self-administered at home, empowering patients to use them wherever they are in the world. This would save healthcare professionals valuable time and resources and reduce carbon emissions across supply chains. It’s an exciting and growing opportunity space, although it needs more research. Another important advantage of the nasal administration route for vaccines is that it has been proven to provide better protection than with injectable vaccines. This is because, while both nasal and injected products stimulate a systemic immune response, when you vaccinate in the nose, the body also creates a local immune response. As many viruses enter the body through your mucosae, including those in the nose, the local immune response that’s triggered in the respiratory tract may provide patients with a first line of defence. 6 What is the long-term strategy with AmorphOX®? Orexo was founded over 30 years ago with a clear vision to develop innovative drugs using proprietary drug-delivery technologies. With AmorphOX, we are continuing that legacy as the platform is the backbone of our future product pipeline. Unlocking the full potential of AmorphOX is central to our growth strategy. Powder-based medications are advancing rapidly, and the versatility of this technology opens up a wide range of opportunities. We’re well positioned to drive this forward at Orexo, but we also see significant value in partnering with other pharmaceutical companies, where our technology can enable exciting new possibilities for their product candidates. Written by Georgina Hoy For further information, please contact: Lena Wange, IR & Communications Director E-mail: ir@orexo.com About Orexo Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2024 amounted to SEK 590 million, and the number of employees 110. Orexo is listed on Nasdaq Stockholm's main list and is available as ADRs (ORXOY) on the OTCQX market in the US. For more information on Orexo, visit www.orexo.com. You can also follow Orexo on X, LinkedIn, and YouTube. Complete links to all references see attached PDF 1 OX124: Positive results from human PK study assessing Orexo’s new intranasal naloxone formulations for opioid overdose reversal; link PR. Orexo announces positive results from pivotal trial for its leading pharmaceutical pipeline asset OX124; link PR. OX125: Positive results from human PK study assessing Orexo’s intranasal nalmefene formulations for opioid overdose reversal; link PR. OX640: Orexo announces positive data from phase 1 clinical study for OX640 - a nasal epinephrine rescue medication for allergic reactions; link PR. Orexo announces positive topline data from clinical study of OX640 in subjects with and without allergic rhinitis; link PR 2 Henriques, P., Fortuna, A., Doktorovová, S. (2022). Spray dried powders for nasal delivery: Process and formulation considerations. European Journal of Pharmaceutics and Biopharmaceutics. 176, 1-20. 3OX640: Epinephrine Nasal Powder - a sustainable and reliable option for the treatment of anaphylaxis; link https://orexo.com/media/o50cci0y/eaaci-2025-nasal-epinephrine-stability-final-1.pdf.Bioavailability and Stability of Epinephrine Nasal Powder Formulations for Treatment of Anaphylaxis; https://orexo.com/media/k1vhowgj/ox640-001_aaaai_poster-feb-2024-1.png. 4Vaccine in vivo study: Orexo announces positive data for powder-based intranasal vaccine formulated with the AmorphOX technology; link PR. 5https://pmc.ncbi.nlm.nih.gov/articles/PMC9678288/#:~:text=Utilizing%20non%2Dinvasive%20alternatives%20(94.1,non%2Ddevice%2Drelated%20approaches. 6 Kiyono, H., Ernst, P. B. Nasal vaccines for respiratory infections. Nature 641, 321–330 (2025). https://doi-org.sutd.idm.oclc.org/10.1038/s41586-025-08910-6.

VaccinePhase 1Clinical Result

11 Jun 2025

·www.prnewswire.com

Elysium Therapeutics' Investor Webcast Highlights "Fentanyl Rebound" as Key Challenge in Reducing Opioid Overdose Hospitalizations and Deaths

Elysium's Synthetic Opioid Overdose Prevention and Reversal (SOOPR™) technology designed specifically to combat oral fentanyl overdose LYONS, Colo., June 11, 2025 /PRNewswire/ -- Elysium Therapeutics, an emerging biopharmaceutical company developing treatments specifically designed to rescue and reverse overdoses caused by oral opioids, including synthetic opioids like fentanyl, recently hosted a webcast to educate investors and pharmaceutical leaders on the pressing need to develop overdose rescue therapies designed specifically for synthetic opioids, like fentanyl. Entitled, "Innovating Solutions to Combat Fentanyl Rebound" and led by Greg Sturmer, CEO, the presentation noted that short-acting opioid antagonists like Narcan® and Opvee® are frequently ineffective in the management of synthetic opioid overdoses1, with 20 to 45% of overdose victims initially rescued with naloxone experiencing a re-narcotization event. Sturmer commented: "When fentanyl is taken orally, individuals can face a danger zone, a period of respiratory depression that can last six to eight hours, which far outlasts the window provided by currently available rescue agents that only last, at most, 30 minutes. The result is nearly half of those initially given a dose of today's rescue medications experience a rebound or re-narcotization event, which can lead to a hypoxic brain injury, cardiovascular toxicity or death." To address this critical shortcoming, Elysium designed its Synthetic Opioid Overdose Prevention and Reversal (SOOPR™) technology to be both faster acting and with the potential to offer overdose protection out to approximately 24-hours. Additionally, Elysium designed SOOPR with an intramuscular route of administration, which grants more reliable dosing, in comparison to intranasal administration, which can lead to partial and uncertain dosing in high stress settings. Sturmer added: "SOOPR was designed specifically for synthetic opioids, which are now the number one killer of adults aged 18 to 45 in the U.S. The need for a rapid-acting, long-duration reversal agent, such as SOOPR, is extreme given its potential to reduce the likelihood of hypoxic brain injury, cardiovascular events, re-narcotization, and death. Recognizing this opportunity, Elysium is planning to rapidly advance the SOOPR clinical program along a timeline that could enable the technology to reach the market in the next two to three years." About SOOPR™ (Synthetic Opioid Overdose Prevention and Rescue) SOOPR (Synthetic Opioid Overdose Prevention and Reversal) is a rapid-onset, long-acting rescue agent specifically designed to address overdose from synthetic opioids, including oral fentanyl. SOOPR utilizes a proprietary long-acting naloxone reversal formulation with faster onset kinetics versus Narcan® delivered via long-acting injection (LAI) technology. The technology is designed to rapidly restore respiration and provide 18 – 24 hours of effective opioid blockade to minimize the risk of re-narcotization, while also providing protection from same-day re-use of opioids. SOOPR has been endorsed by first responders and OUD treatment professionals as the effective solution urgently needed to address the global opioid overdose epidemic. About Elysium Therapeutics Elysium is an emerging biopharmaceutical company developing treatments specifically designed to rescue and reverse overdoses caused by oral synthetic opioids, including fentanyl. Elysium is working to establish new standards of safety in the opioid industry by developing SMART™ (Safer Medicines Alleviate Risks and Trauma) products, first- and best-in-class medicines that address the limitations and dangers associated with opioids and overdose rescue agents to reduce suffering from opioid-use disorder, opioid overdose, and acute pain. Elysium's lead technology, SOOPR™ (Synthetic Opioid Overdose Prevention and Reversal), is a long-acting opioid antagonist specifically designed to address oral synthetic opioid, including fentanyl, overdose. Tens of thousands of unnecessary overdose deaths each year exemplifies the critical shortcomings of currently available rescue agents, including naloxone and nalmefene. In addition, Elysium is developing oral-overdose protected (O2P™) hydrocodone for the treatment of moderate-to-severe acute pain. For more information, please visit . ¹ Rachael Rzasa Lynn and JL Galinkin Ther Adv Drug Saf 2018, Vol. 9(1) 63–88. SOURCE Elysium Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Nalmefene Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D02104	Nalmefene Hydrochloride	N07BB05	DB06230

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Alcoholism	European Union	H. Lundbeck A/S	24 Feb 2013
Alcoholism	Iceland	H. Lundbeck A/S	24 Feb 2013
Alcoholism	Liechtenstein	H. Lundbeck A/S	24 Feb 2013
Alcoholism	Norway	H. Lundbeck A/S	24 Feb 2013
Opiate Overdose	United States	Hikma Pharmaceuticals USA, Inc.	17 Apr 1995

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Gambling	Phase 3	-	Somaxon Pharmaceuticals, Inc.	01 Aug 2005
Pruritus	Phase 2	-	Avior Bio, Inc.	24 Mar 2022
Smoking Cessation	Phase 2	United States	Somaxon Pharmaceuticals, Inc.	01 Sep 2005
Opioid-Related Disorders	Phase 1	United States	Titan Pharmaceuticals, Inc.	05 Jul 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04828005 (CTgov)	Phase 1	-	84	Naloxone hydrochloride (Intranasal Naloxone)	ngidiaxjtg(lyrqwzljfj) = tfvdnqlqgc fdpneonyfh (whhgstaldd, 0.6117) View more	-	14 Jul 2025
				Nalmefene hydrochloride (Intranasal Nalmefene)	ngidiaxjtg(lyrqwzljfj) = fasoqbzpho fdpneonyfh (whhgstaldd, 0.6240) View more
NCT06719986 (CTgov)	Phase 1	Opiate Overdose	24	Nalmefene HCl injection (Nalmefene Hydrochloride (HCl) Injection)	pbnpzwddts(psqdnlijnq) = jkmezrmpif mwjhsmxapl (ysbolctkwf, 2.033) View more	-	03 Jul 2025
				Naloxone HCl intranasal (Narcan Intranasal)	pbnpzwddts(psqdnlijnq) = ixcyttzbdh mwjhsmxapl (ysbolctkwf, 0.992) View more
NCT06198686 (Company_Website) Manual	Phase 1	Pruritus	12	TH104	vnkfxpujpx(conqdowmhn) = None xoorxsdhyn (fizuudlxwe )	Positive	18 Nov 2024
NCT06198686 (Company_Website) Manual	Phase 1	Chronic liver disease	12	TH104 (Child-Pugh A)	dbscrunfsk(ojemkqxowa) = zvuqiuwdfq ncuspqcald (sykyuncxxa ) View more	Positive	28 Oct 2024
				TH104 (Child-Pugh B)	dbscrunfsk(ojemkqxowa) = lczsmwypxc ncuspqcald (sykyuncxxa ) View more
NCT04759768 (CTgov)	Phase 1	-	68	Nalmefene Hydrochloride (Intranasal Nalmefene)	omgtahbmqs(fnuembcutp) = hyspuzuetd oqsacubrec (kjkopgjien, 6.71) View more	-	13 Aug 2024
				Nalmefene (Intramuscular Nalmefene)	omgtahbmqs(fnuembcutp) = dwdvmgbeym oqsacubrec (kjkopgjien, 1.18) View more
NCT05219669 (CTgov)	Phase 1	Opiate Overdose	24	Nalmefene Hydrochloride (Intranasal Nalmefene 1 Spray in 1 Nostril)	ccxilnxvlx(vcvplhtzcj) = tfyhdsewcs fkhnvjrhbi (wdxwghdcfz, 4.87) View more	-	05 Aug 2024
				Nalmefene Hydrochloride (Intranasal Nalmefene 2 Sprays in 1 Nostril)	ccxilnxvlx(vcvplhtzcj) = alipbodvvb fkhnvjrhbi (wdxwghdcfz, 11.2) View more
Biospace Manual	Phase 1	Chronic liver disease	12	TH104	znarmsuvix(xhbjnbhhln) = eqphnjkgxe omwhgrufef (pjoigusctp ) View more	Positive	11 Dec 2023
				TH104 (Child-Pugh A)	znarmsuvix(xhbjnbhhln) = iumhqtqczh omwhgrufef (pjoigusctp ) View more
Biospace Manual	Phase 1	Cholestatic pruritus	-	TH104	ureelzsawl(jxatttccne) = The Cmax and AUC0-∞ of TH104 was observed to be higher than the tablet product because of a possible reduced presystemic metabolism in the lower GI and liver, which is potentially advantageous for patients with an impaired liver. The half-life and Tmax was observed to be similar for both products. qjfzdbogqt (qapfwqbmqb ) View more	Positive	27 Nov 2023
NCT03096730 (CTgov)	Not Applicable	Pain \| Anesthesia \| Hyperalgesia	150	Normal saline+Remifentanil (Normal Saline)	gillwunvjo(sxpqleevoq) = nvjomlikxm xqgrdyceer (nfmbliundv, 6.0) View more	-	03 Aug 2021
				Sufentanil+Normal saline (Sufentanil)	gillwunvjo(sxpqleevoq) = ejaxpvbbtm xqgrdyceer (nfmbliundv, 23.40) View more
NCT03278886 (PETER PAIN, CTgov)	Phase 1/2	Pain \| Inflammation \| HIV Infections ... View more	11	Low dose naltrexone (Low Dose Naltrexone)	hbtzntiofp(xkyzftvsub) = jkdzxftyhh akuscfzoam (yxsghaqyuu, 22.4) View more	-	03 Aug 2020
				Nalmefene (Nalmefene)	hbtzntiofp(xkyzftvsub) = slgkscakjp akuscfzoam (yxsghaqyuu, NA) View more

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