First Batches of Novel Oral Drug Targeting Suicidal Bipolar Depression Released

The first batches of the oral fixed-dosed combination of D-cycloserine and lurasidone (NRX-101), a phase 3-ready investigational drug targeting suicidal bipolar depression, have been released, maker NRx Pharmaceuticals, Inc. announced. This is the first oral drug targeting suicidal bipolar depression.

In a quarterly report released earlier this year, the Pennsylvania-based pharmaceutical company announced the shift in priority to NRX-101 from its failed trial assessing aviptadil acetate (ZYESAMI®) for treating severe COVID-19 subgroups and subsequently declined Emergency Use Authorization by the US Food and Drug Administration (FDA).

A phase 3 trial of NRX-101 targeting bipolar depression in patients with acute suicidal ideation and behavior (ASIB) will be initiated “in the near term,” the company stated in a news release. “Due to pandemic-related supply chain disruptions, [NRx] invested in developing commercial manufacturing processes in the US prior to initiating this registrational study.”

Related: FDA Approves Dissolving Sublingual Film for Agitation in Schizophrenia, Bipolar I or II

Using the commercial process material in the anticipated clinical study is expected to shorten the time to market availability for the drug. Currently, the only FDA-approved treatment for suicidal bipolar depression is electroshock therapy.

The FDA awarded NRX-101 Breakthrough Therapy Designation and Special Protocol Agreement based on the 2018 STABIL-B phase 2 trial that demonstrated patients treated with NRX-101 after a single infusion of ketamine exhibited substantial improvement over available therapy in reducing depression (P<.03) and suicidality (P<.03) compared to placebo.

References

NRx Pharmaceuticals produces first phase 3-stage NRX-101 drug made using commercial process. News release. NRx Pharmaceuticals. November 9, 2022. Accessed November 14, 2022.

NeuroRx, Inc. Sequential therapy (NRX-100 followed by NRX-101) for the treatment of acute suicidal ideation and behavior in bipolar depression: the STABIL-B study. NCT02974010. May 25, 2021. Accessed November 14, 2022. https://clinicaltrials.gov/ct2/show/study/NCT02974010.

NRx Pharmaceuticals provides business update and reports second quarter 2022 results focusing on reactivation & advancement of its psychiatry franchise. News release. NRx Pharmaceuticals. August 15, 2022. Accessed November 14, 2022.