The timing of the NDAs will depend on completion of 12-month stability data in manufactured lots as required by FDA regulations, NRx noted.
Dr. Jonathan Javitt, chairman and chief scientist of NRx
NRx Pharmaceuticals said the company plans to file two new-drug applications (NDAs) with the U.S. Food & Drug Administration this year.
In a news release, NRx said its legal counsel has advised the company to proceed with an accelerated-approval NDA for NRX-101 to treat bipolar depression in patients with akathisia and an application for NRX-100 (IV ketamine) to treat patients with suicidal depression.
The timing of the NDAs will depend on completion of 12-month stability data in manufactured lots as required by FDA regulations, NRx noted.
As disclosed in an 8K filing, NRx will be filing the NRX-101 application without a commercial partner.
“The addressable market for the accelerated-approval indication is such that a compact and efficient salesforce can be constructed by a small company, such as NRx, and current executives at NRx have previously held primary responsibility for launch of similar-sized pharmaceutical assets,” the company said in a news release.
NRX-101 is an oral combination of the NMDA antagonist D-cycloserine and lurasidone for bipolar depression.
The FDA has awarded fast-track designation for NRX-100, an intravenous ketamine for the treatment of acute suicidality and depression. NRx recently spun off a subsidiary called HOPE Therapeutics to develop and commercialize NRX-100.
The company said it “continues work to enable the distribution of shares in Hope Therapeutics,” the timing of which depends on completion of a public audit and successful review of an SEC Form 10.
“The NRx team has worked diligently since the end of the COVID pandemic to achieve these milestones for our shareholders and most importantly the patients we have always sought to help,” said Dr. Jonathan Javitt, chairman and chief scientist of NRx. “Given the near-term market opportunity represented by an accelerated approval process, NRx anticipates a higher potential return to NRx investors associated with an NRx-led initiative than that which would likely be achieved with a large commercial partner.”