- NRx Pharmaceuticals ( NASDAQ: NRXP ) announced Wednesday the release of the first commercially produced batch of NRX-101, an investigational therapy set to undergo a Phase 3 trial for suicidal bipolar depression in the near term. The company shares added ~11% pre-market in reaction to the news.
- Pandemic-related supply constraints prompted NRx Pharmaceuticals ( NRXP ) to develop commercial manufacturing infrastructure in the U.S. before this registrational trial gets underway.
- With the transition to U.S.-based production complete, the company plans to use the commercial process material for the study.
- The decision to build U.S. commercial manufacturing capacity was aimed at bringing "the drug to patients at the earliest possible moment, should NRx Pharmaceuticals demonstrate efficacy and safety in the upcoming phase 3 clinical trial," Chief Executive Stephen Willard said.
- NRx Pharmaceuticals ( NRXP ) also intends to study NRX-101, an oral therapy combining D-cycloserine and lurasidone, for post-traumatic stress disorder (PTSD).
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NRx Pharma announces commercial production of drug targeted at suicidal depression