Lurasidone/Cycloserine

Taylor Tieden for BioSpace Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company. The FDA will hand out seven big decisions before the year ends, including one for a rare form of obesity and two for an anti-inflammatory antibody. Read below for more. Dual Decisions for GSK’s Anti-IL-5 Antibody Kicking off the second half of December are back-to-back decisions for GSK, which is proposing its ultra-long-acting antibody depemokimab for the treatment of asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). The FDA’s verdicts are due Dec. 16. Depemokimab is designed to target the IL-5 cytokine, a known player in immune-mediated and inflammatory diseases. This mechanism of action enabled the biologic to ace both the SWIFT-1 and SWIFT-2 trials in asthma, significantly reducing the annualized rate of exacerbations by 48% to 58% as compared with placebo. Similarly, depemokimab aced the ANCHOR-1 and ANCHOR-2 trials in CRSwNP, leading to significant improvements in nasal polyp score and nasal obstructions. If approved, depemokimab would become the first ultra-long-acting biologic available for dosing every six months, according to GSK. Will Third Time Be the Charm for Aldeyra’s Dry Eye Disease Drug? On or before Dec. 16, the FDA is expected to release its decision on Aldeyra Therapeutics’ dry eye disease candidate reproxalap—concluding the agency’s third review of the drug. Aldeyra has been trying to get reproxalap across the regulatory finish line since 2023, when the FDA first swatted it back , citing the company’s failure to establish the drug’s “efficacy in treating ocular symptoms” in dry eye disease. Another rejection came in April this year, with the regulator asking for at least one more study to show reproxalap’s clinical benefit. In June, Aldeyra refiled its application for reproxalap, saying it had reached an agreement with the FDA where the only new clinical data required could come from a dry eye chamber trial, which was successful . The regulator accepted the resubmission in July. Rhythm Seeks Expansion for Rare Obesity Drug Rhythm Pharmaceuticals is proposing to use its subcutaneous melanocortin 4 receptor (MC4R) agonist Imcivree for the treatment of acquired hypothalamic obesity. The FDA is set to release a decision by Dec. 20. Acquired hypothalamic obesity is a rare form of the chronic disease that typically develops in patients who sustain physical injuries, or due to certain anatomical abnormalities of the hypothalamus. This condition is characterized by the disruption of MC4R signaling, leading to dysregulated hunger, energy expenditure and difficulty regulating weight. Rhythm is backing Imcivree’s expansion bid with data from the Phase III TRANSCEND study, which showed a statistically significant 19.8% placebo-adjusted reduction in body mass index in patients given the drug. Imcivree was first approved in late 2020 for chronic weight management in patients with obesity attributed to POMC, PCSK1 or LEPR deficiency. The drug has since also been cleared for Bardet-Biedl syndrome and expanded for use in patients as young as two years of age. Decision Day Nears for Vanda’s Gastroparesis Drug After Rejection, Public Spat After the FDA rejected Vanda Pharmaceuticals’ tradipitant for gastroparesis in September 2024, the Washington-based company very publicly blasted the decision, arguing that the regulator “generally disregarded the evidence provided.” Now, after more than a year of back-and-forth, the FDA is once again set to release a verdict on tradipitant by Dec. 30. Tradipitant is supported by several clinical efficacy trials, plus a 12-week open-label study, non-animal preclinical trials and Vanda’s expanded access program. In January, however, the FDA in an unusual step revealed its reasoning for the rejection, including that one late-stage trial that “did not demonstrate a statistically significant” treatment benefit. The spat between Vanda and the regulator has only become more convoluted—not to mention highly public. The company in January escalated its complaint to former FDA Commissioner Robert Califf, accusing the agency of what it called a “culture of obfuscation and closemindedness.” In April, Vanda again publicly blasted the agency , pointing to “FDA bureaucrats” who “have created policies to avoid scrutiny of their decision-making by habitually denying hearings.” Vanda and the FDA came to a “ collaborative framework ” in October to resolve its disputes. Corcept Eyes Approval for Cortisol Modulator Also by Dec. 30, the FDA is expected to release its decision on Corcept Therapeutics’ relacorilant, an investigational cortisol modulator for the treatment of Cushing’s syndrome. Also known as endogenous hypercortisolism, Cushing’s syndrome develops when the body produces an excess of the cortisol hormone. The disease manifests as a wide variety of syndromes, including hypertension, excessive body hair, easy bruising, fatigue and diabetes, among other symptoms. If left unchecked, Cushing’s syndrome can lead to many different complications, including infections, heart attack and memory problems. Relacorilant addresses Cushing’s syndrome by selectively targeting the glucocorticoid receptor. Data from the pivotal GRACE study showed that relacorilant improved various hypercortisolism symptoms. Corcept also supported its application with confirmatory evidence from the late-stage GRADIENT study, a long-term extension study and a Phase II trial. NRx To Close 2025 With Bipolar Depression Verdict Closing out this list—and the year—is NRx Pharmaceuticals, which is proposing NRX-101 for the treatment of bipolar depression in patients who are at risk of akathisia, a movement disorder that causes a feeling of restlessness. The regulatory review for this drug is ongoing and a decision is expected “prior to December 31, 2025,” according to the company’s 2024 annual report filed in March. NRX-101 is a fixed-dose combination of the NMDA receptor modulator D-cycloserine and the 5-HT2a receptor blocker lurasidone, both of which have separately been approved by the FDA for different indications. Phase IIb/III data showed that NRX-101 cut suicidality by 33% and symptoms of akathisia—a common side effect of antidepressant therapies also associated with suicidality—by 70%. These effects were not statistically significant. If approved, NRX-101 would become the first drug regimen for severe bipolar depression in patients suffering from both acute and sub-acute suicidal ideation or behavior, according to NRx’s website .

FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026. NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of ketamine. Current worldwide generic ketamine market is estimated at $750 million per year. NRx has manufactured initial registration lots of KETAFREE™ and is prepared to scale manufacturing to 1 million vials per month. NRx is awaiting a response to its Citizen Petition filed in August with the FDA seeking the removal of Benzethonium Chloride preservative from all forms of ketamine sold in the United States Dec. 02, 2025 -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has received the Company’s Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free intravenous ketamine formulation. The acknowledgement letter states that the FDA has “made a threshold determination that this ANDA is substantially complete” and issued a goal date of July 29, 2026 for completion of the final review with potential marketing approval. “We appreciate FDA’s careful review and are pleased that it has received our application for KETAFREE™, an important milestone in our effort to bring a single-patient, preservative-free presentation of ketamine to the patients and clinicians who depend on this medicine,” said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. “Current ketamine products are typically supplied in multi-dose vials that contain a preservative called Benzethonium Chloride (BZT) that is not recognized as safe by FDA and banned from hand cleansers and topical antiseptics. BZT was originally added to ketamine and other sterile injectable products in the 1970s at a time when multidose vials of medication were used to treat several patients, a practice that is no longer allowed in US healthcare facilities. BZT is no longer added to new sterile products. The current MAHA initiatives have called for review and removal of toxic substances from foods, drugs, and vaccines and KETAFREE™, is designed to align with those priorities. ” KETAFREE™ is is intended for all currently approved ketamine indications and is manufactured in the United States, supporting national efforts to strengthen the domestic supply of critical medicines. In awarding a Commissioner’s National Priority Voucher last month to a US-based manufacturer of ketamine active pharmaceutical ingredient (API) the FDA recognized the critical strategic nature of ketamine to the nation’s drug supply. KETAFREE™ is separate from NRx’s New Drug Application for NRX-100, which is being developed as an innovative drug for the treatment of suicidal depression and has received Fast Track designation from the FDA. With the KETAFREE™ ANDA now received and deemed substantially complete, the next key milestone is completion of FDA review under the Generic Drug User Fee Amendments framework, with a GDUFA goal date of July 29, 2026. An approval on that timetable would potentially create meaningful 2026 approved drug sales with profitability in line with public markets analysts. The Company continues to advance other elements of its pipeline and its development of HOPE Therapeutics clinics, a report on which will be presented at tomorrow’s Noble Securities NOBLECON conference and available on the Company’s website. NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company focused on Neuroplastic Therapies for the treatment of central nervous system disorders, specifically suicidal depression, PTSD, anxiety, and Autism. The Company combines drug development with a best-in-class network of clinics (HOPE Therapeutics) offering medication management, Transcranial Magnetic Stimulation, and Hyperbaric Oxygen Therapy that combine to achieve rapid response and remission. NRx is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application for its preservative-free ketamine formulation and is anticipating a July 2026 launch. The content above comes from the network. if any infringement, please contact us to modify.