New York, March 05, 2024 - PRISM MediaWire - NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) achieves 'Last Patient, Last Visit' milestone in Phase 2b/3 Trial of NRX-101 for suicidal treatment-resistant bipolar depression. The company confirms completion of the 74th and final evaluable patient's day 42 visit. Topline data is anticipated by the quarter's end. Following this update, NRx's share price surged nearly 20% at Monday's closing bell.
NRx Pharmaceuticals (NASDAQ: NRXP) Announces Last Patient, Last Visit in its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression - Prism MarketView
Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar DepressionThe study database is being cleaned and...
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Positive trial outcomes prompt a $4 million milestone payment from Alvogen, a US-based pharmaceutical company specializing in the development, in-licensing, manufacturing, and marketing of pharmaceutical products. Under the terms, Alvogen assumes responsibility for subsequent development and commercialization expenses for this program. NRx's agreement with Alvogen includes provisions for potential milestone payments totaling up to $329 million, along with a royalty on net sales in the mid-teens.
"This marks the inaugural clinical trial, as far as the company is aware, conducted specifically among outpatients with suicidal bipolar depression. Our prior trial assessed NRX-101's capacity to sustain the antidepressant and anti-suicidal efficacy observed with ketamine administration in a hospital environment. Notably, these patients, facing urgent and exceptional clinical demands, have traditionally been omitted from trials involving all previously recognized antidepressant medications."
Dr. Jonathan Javitt, Founder, Chairman, and Chief Scientist of NRx Pharmaceuticals
Key Points:
- NRX-101, a proprietary blend of the NMDA antagonist D-cycloserine and lurasidone, targets Suicidal Treatment Resistant Bipolar Depression, an area of critical medical need.
- The ongoing Phase 2b/3 trial follows a randomized, prospective, multicenter, double-blind design, spanning six weeks. It compares NRX-101 to lurasidone. Notably, the trial reported no unexpected Serious Adverse Events.
- NRX-101 has garnered significant regulatory recognition, including Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement from the FDA, underscoring its potential in addressing suicidal bipolar depression.
- Bipolar depression represents a grave illness, with one in five individuals afflicted succumbing to its lethal consequences.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
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