NRx Pharmaceuticals (NASDAQ:NRXP) Releases Shareholder Update

The June 2024 meeting of the American Society for Clinical Psychopharmacology (ASCP) strongly emphasized the growing use of intravenous ketamine and intranasal S-ketamine as leading treatments for severe depression and suicidality. Presenters from three open-label studies at the ASCP highlighted that intravenous ketamine is at least as effective, and potentially more so, compared to intranasal S-ketamine. NRx Pharmaceuticals has achieved a significant milestone, reaching the 9-month stability mark with its ketamine formulation, NRX-100, and has begun producing three manufacturing lots for future drug release. Nonclinical safety data for short-term use of NRX-100 has been published and submitted to the FDA.

In public comments at the ASCP, FDA leadership emphasized the need for nonclinical safety data as a prerequisite for approving intravenous ketamine. The immediate need for this form of ketamine, already an approved schedule 3 drug, has increased due to recent regulatory decisions that may delay the approval of more potent schedule 1 psychedelic drugs requiring complex clinical trial designs.

At the ASCP's annual meeting, NRx Pharmaceuticals provided a shareholder update, underscoring its recent activities. Key points included emphasizing intravenous and intranasal ketamine as emerging standards for treating severe depression and suicidality and announcing a planned New Drug Application (NDA) for NRX-100 in 2024. This application is based on well-controlled trials against both placebo and active comparators, and the company has already been granted Fast Track Designation.

An independent FDA advisory panel's recent decision against MDMA, a potent class I psychedelic, has redirected attention to already-approved schedule 3 drugs like ketamine for treating suicidal depression. This decision and emerging guidance highlight the complexities of clinical trials for schedule 1 hallucinogens, which do not have pre-approved human uses. NRx Pharmaceuticals anticipates that a significant issue for the prolonged use of ketamine in depression will be the current multidose vial presentation containing potentially toxic preservatives. NRX-100 aims to be a single-dose, preservative-free medication.

NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for treating central nervous system disorders, including 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 to develop and market NRX-101 for treating suicidal bipolar depression. In addition to its potential as a non-opioid treatment for chronic pain, NRX-101 could also treat complicated urinary tract infections (UTIs).

NRx recently announced plans to submit an NDA for NRX-100 (IV ketamine) to treat suicidal depression, based on clinical trials conducted under the US National Institutes of Health and new data from French health authorities obtained through a data-sharing agreement. The US FDA has granted Fast Track Designation for developing ketamine (NRX-100) as part of a protocol to treat patients with acute suicidality.

HOPE Therapeutics, Inc., a wholly-owned subsidiary of NRx Pharmaceuticals, focuses on developing and marketing an FDA-approved form of intravenous ketamine to treat acute suicidality and depression. HOPE Therapeutics also offers a digital therapeutic-enabled platform designed to enhance and prolong the clinical benefit of NMDA-targeted drug therapy.

NRx Pharmaceuticals continues to advance its research and development efforts, aiming to provide effective treatments for severe depression and suicidality through innovative approaches and strategic partnerships.