NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, is making significant strides in developing treatments for central nervous system disorders. The company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain.
Recently, NRXP announced plans to submit a New Drug Application for NRX-100 (IV ketamine) in the treatment of suicidal depression. This decision is based on results from clinical trials conducted under the US National Institutes of Health and data from French health authorities.
In its quest for FDA approval of Intravenous Ketamine, NRXP has initiated the manufacture of ketamine. The company has also developed a proprietary formulation of IV Ketamine, HTX-100, which is expected to generate patents and be marketed by HOPE Therapeutics, a wholly owned subsidiary of NRx.
NRXP announced successful results of its clinical trial of NRX-101 vs. lurasidone in the treatment of suicidal bipolar depression. The positive data from this study makes NRXP eligible to receive an additional $4 million from partners Alvogen, Inc. and Lotus Pharmaceuticals, Inc.
NRx has also licensed the exclusive rights to a method patent for treatment of chronic pain with DCS from Prof. Vania Apkarian of Northwestern University. The company is also developing treatments for Complicated UTI and Pyelonephritis with FDA Qualified Infectious Disease Product and Fast Track Designation.
NRXP has established HOPE Therapeutics to develop and launch IV Ketamine together with related technologies. The company plans to distribute shares of HOPE Therapeutics and royalty rights on Ketamine sales to existing NRx shareholders.