RADNOR, Pa. - NRx Pharmaceuticals, Inc. (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has reportedly completed the enrollment for its phase 2b/3 clinical trial of NRX-101 for the treatment of suicidal bipolar depression that is resistant to conventional treatments. This development was highlighted by Lotus Pharmaceutical Co. Ltd (1975.TW), NRx's strategic partner in the Asia Pacific, in their recent financial filing dated February 7.
The trial's completion was described as a significant milestone for NRx Pharmaceuticals, with results expected in the second quarter of this year. NRX-101, which is currently being developed in partnership with Lotus and Alvogen, Inc., has been designated by the FDA as an investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain.
Stephen Willard, CEO of NRx Pharmaceuticals, expressed gratitude towards Lotus for their support in advancing NRX-101, especially in the Asia Pacific region, where, according to the World Health Organization, suicidal depression represents a major public health issue.
NRx Pharmaceuticals is also preparing to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, backed by clinical trial results and data from French health authorities. The U.S. FDA has granted Fast Track Designation for the development of ketamine (NRX-100) as part of a protocol for treating patients with acute suicidality.
In addition to its potential use in bipolar depression and chronic pain, NRX-101 may also serve as a non-opioid treatment for chronic pain and a treatment for complicated urinary tract infections.
The information provided in this article is based on a press release statement from NRx Pharmaceuticals, Inc.
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