NRx Pharmaceuticals awarded filing fee waiver by FDA for NRX-100 application

NRx Pharmaceuticals (NRXP) announced the grant of a filing fee waiver by the FDA to exempt the company from a $4.3M fee to file its New Drug Application for NRX-100, or preservative-free ketamine. The waiver is granted at the discretion of the FDA to Small Business Entities and for drugs that are deemed to be necessary for Public Health. The company anticipates that this waiver enables the completion of its New Drug Application for NRX-100 with currently-available corporate resources. The NDA filing is anticipated by the end of Q2. This patent-pending process is anticipated to yield long-term exclusivity should NRX-100 be approved by the FDA. NRx will be submitting data from controlled clinical trials that demonstrate ketamine to be superior to both a placebo and an active comparator, as well as either non-inferior or superior to electroshock therapy in treating various forms of depression, including patients with active suicidal ideation.