NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced that the Company posted a new Shareholder Update Letter on its website NRx Shareholder Update and further invites interested parties to subscribe to their email alert service to stay up to date on company’s progress here: NRx Email Alerts . (Note: not all updates will be included in a Press Release in the future).
Today’s update highlights potential implications of the Company’s recent activities at the annual meeting of the American Society of Clinical Psychopharmacology. The key points include:
- Intravenous and intranasal ketamine were highlighted as emerging standards of care for severe depression and suicidality
- Planned NDA filing for NRX-100, our preservative free IV ketamine, for Suicidal Depression in 2024, is based on well controlled trials against both placebo and active comparator. Fast Track Designation was previously granted
- An independent FDA advisory panel recently voted against MDMA, a potent, class I psychedelic, refocusing attention on already-approved Schedule 3 drugs such as ketamine for treatment of suicidal depression. The FDA panel and emerging guidance highlights the complexity of clinical trials of DEA Schedule 1 hallucinogens that do not have already-approved human uses
- NRx anticipates that an important issue for longer term use of ketamine in depression will be the current multidose vial presentation that contains potentially toxic preservatives previously acceptable for one time use but less suitable for repeated use. NRX-100 is planned as a single-dose, preservative-free medication.
Please subscribe to the Company’s email for future updates. NRX Email Alerts Not all of these will be the subject of a Press Release in the future.
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 NRX-100 (IV ketamine), 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.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals, focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
