Motion Sickness

“CDER is still evaluating the impact the RIF may have on CDER’s immediate operations,\" the federal department said in an April 14 letter to Vanda.\n Vanda Pharmaceuticals is suing the FDA again, this time alleging the agency is unlawfully delaying a hearing to discuss the rejection of the biotech\'s stomach disorder drug last year.The FDA has asked the commissioner’s office to set a hearing by mid-September 2025 for Vanda\'s request, which was prompted by a complete response letter (CRL). In a letter to the biotech last week, the agency cited multiple reasons for the delay—including the company’s numerous ongoing legal cases with the agency, plus the recent mass federal layoffs.Vanda has filed a lawsuit against the federal agency for the \"unlawful delay\" that is currently pending in Washington, D.C., courts, a Vanda spokesperson told Fierce.   The drug at the heart of the dispute is tradipitant, an investigational NK-1R antagonist that the FDA rejected as a gastroparesis treatment in September 2024. At the time, Vanda CEO Mihael Polymeropoulos, M.D., argued that the CRL generally disregarded the evidence the company had provided to support the application.In a late-stage study (PDF), tradipitant was shown to be no better than placebo at reducing the severity of nausea across 12 weeks of treatment, but Vanda identified a baseline imbalance of rescue medication use between the treatment arms and some poor compliance with the study drug as a potential cause for the miss. When excluding patients that Vanda deemed to be confounders, the company argued that the study had actually hit its primary endpoint.After receiving the rejection, the FDA provided Vanda with a notice for the opportunity for a hearing on Jan. 7, 2025—well past the statutory deadline, according to Vanda\'s spokesperson.Despite the delay, Vanda accepted the FDA’s offer on Jan. 27 and submitted the requested information on March 17, the spokesperson told Fierce.Vanda contends it accepted the hearing offer within the required timeframe, and based on its understanding of FDA procedures, believes the agency is obligated to hold the hearing within 120 days of the notice. According to Vanda, that timeline would mean the hearing should be scheduled on or before May 7, 2025.  The FDA confirmed receipt of the submitted information on March 17 in an April 14 letter sent to Vanda from G. Matthew Warren, director of the FDA’s Office of Scientific Integrity. Warren wrote that CDER is working to thoroughly review Vanda’s submission and asked the FDA commissioner to issue a scheduling order in which CDER responds to Vanda’s request no later than Sept. 12.The FDA department cited several reasons for the proposed September deadline, with the first being that Vanda’s request for a summary judgment or hearing includes more than 15,000 pages, some of which are new materials that weren’t included in the company’s new drug application (NDA).  The timeline also considers the fact that the staffers in the Office of Immunology and Inflammation (OII) reviewing the submission are the same employees working on Vanda’s pending NDA for tradipitant in a new proposed indication of vomiting induced by motion sickness, which Vanda submitted at the end of 2024.The agency said OII workers are also providing insight related to multiple lawsuits recently filed by Vanda regarding tradipitant. These suits against the FDA include challenging timeframes by which the FDA must act; Vanda has also said that CDER tried to wait six months to respond to actions for the company’s insomnia program. Plus, Vanda is challenging a partial clinical hold related to certain tradipitant trials and contests the authority of FDA officials to review and hold a hearing on the application.Earlier this month, Vanda filed suit against the agency related to its drug Hetlioz, protesting the rules around promoting drugs’ off-label uses.In relation to Vanda, OII staff are also helping with technical review and assistance related to an ongoing tradipitant expanded access trial for gastroparesis, the letter continues.Unrelated to Vanda, the FDA\'s letter outlined CDER’s other tasks, like reviewing applications and work related to other public health issues.Finally, the health agency underscored the widespread layoffs that occurred on April 1, when President Donald Trump’s administration cut 3,500 FDA workers. This impacted CDER offices assigned to lead the review and draft the written response for this matter, according to the federal letter.“Additionally, the RIF impacted leadership of the CDER Office of New Drugs, as well as CDER (including OII) review divisions’ access to relevant subject matter experts, administrative support staff, library staff and academic journal subscriptions,” Warren wrote in the letter. “CDER is still evaluating the impact the RIF may have on CDER’s immediate operations, which may limit the speed at which the center can complete a thorough analysis of Vanda’s submission in the near term.” At the time, HHS said the FDA workforce reduction wouldn’t impact drug, medical device or food reviewers. Since then, hundreds of biotech leaders signed a letter decrying the FDA changes and detailing how it has already affected some companies.In the letter, CDER expressed concerns that an earlier deadline would “strain already limited” resources and “unreasonably constrain” the center’s ability to properly address Vanda’s submission requesting summary judgment or a hearing.“CDER is committed to working diligently to comply with our obligations in this matter, including meeting the deadline to be set forth by the commissioner,” Warren concluded. “However, competing agency priorities and judicial developments relating to various lawsuits Vanda has initiated may arise unexpectedly that are outside the control of either the center or the agency as a whole.”Both the FDA and the agency’s parent organization, the Department of Health and Human Services, did not respond to Fierce Biotech’s request for comment. 

Q4 2024 total revenues of $53.2 million, +17% compared to Q4 2023 Q4 2024 Fanapt® net product sales of $26.6 million, +18% compared to Q4 2023 Full year 2024 total revenues of $198.8 million, +3% compared to full year 2023 Full year 2025 revenue expected to grow to $210 to $250 million Psychiatry portfolio revenue expected to grow to greater than $750 million in 2030 Fanapt® MAA for bipolar I disorder and schizophrenia submitted in Q4 2024 BysantiTM (milsaperidone) NDA for bipolar I disorder and schizophrenia expected to be submitted in Q1 2025 HETLIOZ® MAA for Smith-Magenis syndrome submitted in Q4 2024 Tradipitant NDA for motion sickness submitted in Q4 2024 Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025 WASHINGTON, Feb. 13, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2024. "Strong revenue growth for Fanapt is putting us on a significant growth trajectory for 2025 and beyond, supported also by the commercial performance of Hetlioz and Ponvory. The Fanapt long acting injectable program, the NDA for Bysanti for bipolar disorder and schizophrenia along with its development for major depressive disorder have the potential to drive future growth in our psychiatry portfolio for many years to come," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "Tradipitant's NDA for motion sickness was filed with a potential approval this year, while we are pursuing approval in gastroparesis and the development of tradipitant to improve tolerability of GLP-1 analog Wegovy. Our anti-inflammatory portfolio, anchored by Ponvory, was strengthened with the addition of imsidolimab from Anaptys, an IL-36 receptor inhibitor for the treatment of generalized pustular psoriasis. We plan to file a BLA later this year while we are exploring registration in Europe and Japan as well as the development of this novel drug for other inflammatory disorders with an unopposed action of the IL-36 system. In 2024 we returned to revenue growth driven by the commercial launches in bipolar disorder and multiple sclerosis and advanced our development pipeline with a number of products at or near marketing applications. All this was achieved by the hard work, ingenuity and efficiency of our organization and its wonderful people." Financial Highlights Fourth Quarter of 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $53.2 million in the fourth quarter of 2024, a 17% increase compared to $45.3 million in the fourth quarter of 2023 and a 12% increase compared to $47.7 million in the third quarter of 2024. Fanapt® net product sales were $26.6 million in the fourth quarter of 2024, an 18% increase compared to $22.6 million in the fourth quarter of 2023 and an 11% increase compared to $23.9 million in the third quarter of 2024. HETLIOZ® net product sales were $20.0 million in the fourth quarter of 2024, a 5% decrease compared to $21.1 million in the fourth quarter of 2023 and a 12% increase compared to $17.9 million in the third quarter of 2024. PONVORY® net product sales were $6.5 million in the fourth quarter of 2024, an increase of 11% compared to $5.9 million in the third quarter of 2024. The acquisition of PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson Company, was completed on December 7, 2023. Net loss was $4.9 million in the fourth quarter of 2024 compared to net loss of $2.4 million in the fourth quarter of 2023 and net loss of $5.3 million in the third quarter of 2024. Cash, cash equivalents and marketable securities (Cash) was $374.6 million as of December 31, 2024, representing a decrease to Cash of $1.6 million compared to September 30, 2024. Full Year 2024 Total net product sales from Fanapt®, HETLIOZ® and PONVORY® were $198.8 million for the full year 2024, a 3% increase compared to $192.6 million for the full year 2023. Fanapt® net product sales were $94.3 million for the full year 2024, a 4% increase compared to $90.9 million for the full year 2023. HETLIOZ® net product sales were $76.7 million for the full year 2024, a 23% decrease compared to $100.2 million for the full year 2023. The decrease relative to the full year 2023 was the result of continued generic competition in the U.S. PONVORY® net product sales were $27.8 million for the full year 2024. The acquisition of PONVORY® from Janssen was completed on December 7, 2023. Net loss was $18.9 million for the full year 2024, compared to net income of $2.5 million for the full year 2023. Cash was $374.6 million as of December 31, 2024, representing a decrease to Cash of $13.6 million compared to December 31, 2023. Key Operational Highlights Fanapt® (iloperidone) Fanapt® was approved in the second quarter of 2024 for the acute treatment of bipolar I disorder. Vanda initiated the commercial launch of Fanapt® in this indication in the third quarter of 2024. In the fourth quarter of 2024, as compared to the fourth quarter of 2023, new patient starts, as reflected by new to brand prescriptions (NBRx),1 increased by over 160% and Fanapt® net product sales increased by 18%. Vanda initiated a Phase III program for the long acting injectable (LAI) formulation of Fanapt® in the fourth quarter of 2024. Vanda plans to initiate a study of the Fanapt® LAI as a once-a-month injectable for the treatment of hypertension to address both treatment resistance and treatment compliance. Vanda submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the fourth quarter of 2024 for Fanapt® for bipolar I disorder and schizophrenia. Bysanti™ (milsaperidone) Vanda expects to submit a New Drug Application (NDA) for Bysanti™ to the U.S. Food and Drug Administration (FDA) for the treatments of acute bipolar I disorder and schizophrenia in the first quarter of 2025. Exclusivity, including pending patent applications, could extend into the 2040s. Vanda initiated a Phase III clinical study for Bysanti™ as a once-daily adjunctive treatment for major depressive disorder (MDD) in the fourth quarter of 2024. Results are expected in 2026. HETLIOZ® (tasimelteon) Vanda has initiated clinical programs for HETLIOZ® in pediatric insomnia and delayed sleep phase disorder (DSPD) and these programs are ongoing. Vanda's MAA for HETLIOZ® and HETLIOZ LQ® for Smith-Magenis Syndrome (SMS) is pending with the EMA. PONVORY® (ponesimod) Vanda initiated the commercial launch of PONVORY® for the treatment of relapsing forms of multiple sclerosis in the third quarter of 2024. Investigational New Drug (IND) applications for PONVORY® in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Tradipitant The NDA for tradipitant for the treatment of motion sickness was submitted to the FDA in the fourth quarter of 2024. Vanda initiated a clinical trial to study tradipitant in the prevention of vomiting induced by a GLP-1 analog, Wegovy (semaglutide), in the fourth quarter of 2024. Vanda has accepted the opportunity for a hearing with the FDA on the approvability of the NDA for tradipitant for the treatment of symptoms of gastroparesis. Imsidolimab In February 2025, Vanda announced it entered into an exclusive, global license agreement with AnaptysBio, Inc. (Anaptys) for the development and commercialization of imsidolimab (IL-36R antagonist mAb). Vanda expects to initiate and complete the technology transfer activities in 2025 and immediately begin preparing the Biologics License Application (BLA) and MAA for generalized pustular psoriasis (GPP) for the US and EU. The imsidolimab BLA for GPP is expected to be submitted to the FDA in 2025. Early-Stage Program Highlights VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda expects to initiate a Phase III program in 2025. The IND application for VCA-894A in the treatment of Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. Previously in 2023, VCA-894A was granted Orphan Drug Designation for the same indication. The Phase I clinical study for VCA-894A expects to enroll the patient by mid-2025. In December 2024, Vanda announced that the FDA has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for the treatment of polycythemia vera (PV), a form of a rare hematologic malignancy that is estimated to affect 1 in 2,000 Americans. Key Regulatory Milestones Tradipitant NDA for motion sickness submitted in Q4 2024. Fanapt® MAA for bipolar I disorder and schizophrenia submitted in Q4 2024. HETLIOZ® MAA in Smith-Magenis syndrome (SMS) submitted in Q4 2024. Bysanti™ NDA for bipolar I disorder and schizophrenia expected to be submitted in Q1 2025. Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in 2025. GAAP Financial Results Net loss was $4.9 million in the fourth quarter of 2024 compared to net loss of $2.4 million in the fourth quarter of 2023. Diluted net loss per share was $0.08 in the fourth quarter of 2024 compared to diluted net loss per share of $0.04 in the fourth quarter of 2023. Net loss was $18.9 million for the full year 2024 compared to net income of $2.5 million for the full year 2023. Diluted net loss per share was $0.33 for the full year 2024 compared to diluted net income per share of $0.04 for the full year 2023. 2025 Financial Guidance and 2030 Revenue Targets Vanda expects to achieve the following financial objectives in 2025: Vanda is providing 2030 revenue targets. For the psychiatry portfolio alone, Vanda is targeting annual revenue in excess of $750 million in 2030, assuming the potential approval of Bysanti™ for the treatments of acute bipolar I disorder and schizophrenia in early 2026, the potential approval of Bysanti™ for the treatment of MDD, and the potential approval of Fanapt® LAI. Vanda is also targeting total annual revenue in excess of $1 billion in 2030. Conference Call Vanda has scheduled a conference call for today, Thursday, February 13, 2025, at 4:30 PM ET. During the call, Vanda's management will discuss the fourth quarter and full year 2024 financial results and other corporate activities. Investors can call 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode number 2881765. A replay of the call will be available on Thursday, February 13, 2025, beginning at 8:30 PM ET and will be accessible until Thursday, February 20, 2025 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 2881765. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2025 Financial Guidance and 2030 Revenue Targets" above and the related implied growth of Vanda's business, and statements regarding Vanda's plans for pursuit of FDA approval of BysantiTM for the treatments of acute bipolar I disorder and schizophrenia and imsidolimab for the treatment of GPP, and the related timelines; Vanda's expectations with respect to the growth opportunities for its psychiatry frachise; Vanda's consideration of foreign regulatory approval for imsidolimab and its potential development for other inflammatory disorders; Vanda's clinical development plans and expected timelines for Fanapt® LAI, BysantiTM for the treatment of MDD, VQW-765 for the treatment of acute performance anxiety in social situations, and VCA-894A for the treatment of CMT2S; the commercial and therapeutic potential for BysantiTM; the potential to extend patent exclusivity for BysantiTM into the 2040s; the anticipated timing of the initiation and completion of technology transfer activities and the preparation of regulatory filings in the US and EU for imsidolimab; and the prevalence of PV are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its psychiatry portfolio and overall business; the results of Vanda's review of foreign regulatory opportunities for imsidolmab; Vanda's ability to identify additional indications for imsidolimab; Vanda's ability to complete and submit to the FDA the NDA for BysantiTM for the treatments of acute bipolar I disorder and schizophrenia in the first quarter of 2025; Vanda's ability to complete and submit the BLA for imsidolimab for the treatment of GPP in 2025; Vanda's ability to complete the Phase III clinical study for BysantiTM for MDD and receive results in 2026; Vanda's ability to initiate the Phase III program for VQW-765 in 2025; Vanda's ability to enroll the CMT2S patient in the Phase I clinical study for VCA-894A by mid-2025; Vanda's ability to complete the clinical development of, obtain regulatory approval for, and successfully commercialize, BysantiTM for the treatments of acute bipolar I disorder, schizophrenia and MDD; Vanda's ability to satisfy the conditions necessary to extend BysantiTM's patent exclusivity into the 2040s; Vanda's ability to initiate and complete the technology transfer activities and prepare the BLA and MAA for imsidolimab in the specified timeframes; and the accuracy of the estimate regarding the prevalence of PV. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 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Original research article published by Frontiers, a top peer-reviewed scientific journal WASHINGTON, Feb. 13, 2025 /PRNewswire/ -- Otolith Labs, a medical technology company developing prescription medical devices for the treatment of vestibular disorders, announced results from an exploratory user study investigating the effect of vestibular stimulation on cybersickness from virtual reality (VR) experiences. The study demonstrated that subjects utilizing the Otolith technology had improved virtual environment experiences with lower reported nausea and longer VR durations. Continue Reading The results indicate that Otolith's vestibular stimulation technology has a positive influence on cybersickness in a provocative virtual environment. Otolith's vestibular stimulation technology has a positive influence on cybersickness in a provocative VR environment. Post this "For Otolith, while VR is not our direct focus, this study is a foundational step toward understanding how visual stimuli interact with vestibular function. Cybersickness from VR has important research applications because, unlike vertigo, which may be episodic, the onset of VR-induced motion sickness can be controlled, which allows us to utilize these occurrences for clinical research," said Didier Depireux, PhD, Otolith Co-Founder, Chief Science Officer, and Study Co-Author. Exploring vestibular stimulation to reduce the influence of cybersickness on virtual reality experiences. The exploratory user study was conducted by Shamus Smith, et al. between 2020 and 2021. It was conducted at the University of Newcastle. 30 healthy individuals were recruited, 9 female and 21 male, with an age range of 19-37 years. Participants completed the Motion Sickness Susceptibility Questionnaire (MSSQ) and demographic questionnaire. They were assigned to three groups: Device Group 1 (low stimulation setting), Device Group 2 (medium stimulation setting), and Control Group (no stimulation device). All participants were fitted with an Oculus VR headset and a VR roller-coaster simulation ride was activated. Participants in the device groups were fitted with an Otolith device positioned on the mastoid behind the right ear. For the duration of the VR simulation ride, participants provided verbal reports of their nausea. Directly after the ride, participants completed a Motion Sickness Assessment Questionnaire (MSAQ). While the control group held expected relationships between perceived susceptibility and experienced motion sickness, neither device group did. This indicates that the Otolith device stimulation had a positive influence on the motion sickness brought on by the virtual experience. "Millions of Americans endure the challenges of vestibular disorders every day, with limited non-invasive treatments available. Otolith is developing a novel wearable vestibular stimulation device designed to reduce chronic vestibular symptoms and allow users to maintain tasks of daily living. We are thrilled to see these study results demonstrate the effectiveness of our technology," said Jon Akers, Otolith Co-Founder and Chief Technology Officer. The full article can be accessed here: About Otolith Labs Otolith Labs is developing prescription medical devices for the treatment of vestibular disorders, conditions experienced by millions of Americans. Otolith's patented technology, which received Breakthrough Device Designation from the FDA for the treatment of chronic vertigo, uses precisely tuned vibrations to interact with the acceleration sensors in the inner ear, mitigating the symptoms of vertigo. Otolith is conducting clinical trials to evaluate its technology as an immediate symptom-relief treatment for chronic vertigo associated with vestibular disorders. About the University of Newcastle The University of Newcastle is a public university in Newcastle, New South Wales, Australia. Established in 1965, it is committed to its core values of equity, excellence, engagement, and sustainability. The University is a globally respected education institution dedicated to solving the world's most pressing challenges. With three Colleges and 20 Schools, it oversees the education of more than 37,000 students. Media contact: Annalise Kelloff Otolith Labs [email protected] SOURCE Otolith Labs WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED