NRx Pharmaceuticals (NASDAQ:NRXP) Releases Shareholder Update - June 10, 2024

The June 2024 meeting of the American Society for Clinical Psychopharmacology (ASCP) shed light on the increasing adoption of intravenous ketamine and intranasal S-ketamine as emerging standards for treating severe depression and suicidality. Presenters at the ASCP shared insights from three open-label studies suggesting that intravenous ketamine is at least as effective as intranasal S-ketamine, with potential advantages noted.

NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, has made significant progress with its ketamine formulation, NRX-100. The company has reached the nine-month stability milestone and initiated three manufacturing batches for future drug release. Recent publications of nonclinical safety data for short-term use of NRX-100 have been submitted to the FDA. During the ASCP meeting, FDA leadership emphasized the necessity for nonclinical safety data for intravenous ketamine as a prerequisite for its approval.

The demand for intravenous ketamine, already an approved Schedule 3 drug, has been amplified due to regulatory decisions that may delay the development of Schedule 1 psychedelic drugs, which would require more complex clinical trial designs.

NRx Pharmaceuticals recently announced a new Shareholder Update Letter, highlighting recent developments and inviting stakeholders to subscribe to their email alert service for ongoing updates. Key points from the update include the increased focus on intravenous and intranasal ketamine as standard treatments for severe depression and suicidality.

The company plans to file a New Drug Application (NDA) for NRX-100 in 2024, targeting suicidal depression based on well-controlled trials against both placebo and active comparators. The FDA has previously granted Fast Track Designation for NRX-100.

An independent FDA advisory panel's recent vote against MDMA, a potent Schedule 1 psychedelic, has redirected attention to already-approved Schedule 3 drugs such as ketamine for treating suicidal depression. The FDA panel and emerging guidance highlight the complexity of clinical trials for DEA Schedule 1 hallucinogens that lack pre-approved human uses.

NRx Pharmaceuticals anticipates addressing an important issue regarding the long-term use of ketamine for depression. Currently available multidose vials contain preservatives suitable for one-time use but potentially toxic for repeated use. NRX-100 is being developed as a single-dose, preservative-free medication to mitigate these concerns.

About NRx Pharmaceuticals:
NRx Pharmaceuticals is dedicated to developing therapeutics based on its NMDA platform to treat central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The company is advancing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus to develop and market NRX-101 for suicidal bipolar depression. NRX-101 also holds potential as a non-opioid treatment for chronic pain and complicated urinary tract infections.

Recently, NRx Pharmaceuticals announced plans to submit a New Drug Application for NRX-100, based on well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained French health authority data. The company received Fast Track Designation from the US FDA for developing ketamine (NRX-100) as part of a protocol to treat patients with acute suicidality.

About HOPE Therapeutics, Inc.:
HOPE Therapeutics, Inc., wholly owned by NRx Pharmaceuticals, is focused on developing and marketing an FDA-approved intravenous ketamine form for treating acute suicidality and depression. The company also incorporates a digital therapeutic-enabled platform to enhance and preserve the clinical benefit of NMDA-targeted drug therapy.

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