NRx Pharmaceuticals, Inc., (Nasdaq : NRXP, NRx Pharmaceuticals), a clinical-stage biopharmaceutical firm, announced today that the U.S. Food and Drug Administration denied the Breakthrough Therapy designation (BTD). The FDA denied ZYESAMI (r) (aviptadil). It emphasized the company’s NRX101 BTD compound for Bipolar Disorder associated with Suicidality and its NRX-101 BTD drug. Based on the positive findings of a subgroup analysis of patients treated with Aviptadil and placebo, and who had respiratory failure due to Critical COVID-19, the request for BTD was made.
“While we are disappointed by FDA’s decision, it was announced that our strategic focus has shifted to the advancement and designation of NRX-101 as Breakthrough Therapy. Topline data from our ongoing Phase II trial of NRX101 in bipolar depression and sub-acute suicide ideation (SSIB), should be available by the end this year. COVID-19 has unfortunately also led to a mental health crisis. This includes suicide attempts and depression. Robert Besthof, interim CEO at NRx Pharmaceuticals, stated that our commitment to patients with high unmet medical needs is still the heart of our work.
“ZYESAMI’s mechanism, well-characterized safety profile and the well-known safety profile of ZYESAMI, NRx Pharmaceuticals will continue to evaluate options for its use in high unmet pulmonary and other non-pulmonary indications.”
About NRx Pharmaceuticals
NRx Pharmaceuticals, Inc. (“NRx Pharmaceuticals” or the “Company”) draws upon decades of collective, scientific, and drug-development experience to address very high unmet needs of patients and bring improved health to patients. The U.S. Food and Drug Administration (“FDA”) has additionally granted Breakthrough Therapy designation, a Special Protocol Agreement, and a Biomarker Letter of Support for NRX-101, an investigational medicine for the treatment of severe bipolar depression in patients with acute suicidal ideation and behavior (ASIB) after initial stabilization with ketamine or other effective therapy. NRx Pharmaceuticals is led by executives who have held leadership roles at Lilly, Pfizer, and Novartis as well as major investment banking institutions.
Cautionary Note Regarding Forward-Looking Statements
This announcement of NRx Pharmaceuticals, Inc. includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the Company’s strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the Company’s management.
The Company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.
