CEO Update: Breakthrough Therapy Designation

Recently, we’ve received several questions about the Breakthrough Therapy Designation (BTD) application NRx submitted to the US Food and Drug Administration (FDA) for ZYESAMI™ (aviptadil) last month. As you know, we received BTD for our psychiatry drug NRX-101 for suicidal bipolar depression. Admission to the BTD program provided us with increased access to review guidance and input from the Division of Psychiatry Products.

I’m happy to take a few minutes to give you more information about the application and why we believe ZYESAMI is worthy of BTD.

In June 2020, FDA granted us a Fast Track Designation for the use of aviptadil to treat Critical COVID-19. This designation was based on the life-threatening nature of COVID-19, the clear unmet medical need (that remains today) for a drug to treat patients with respiratory failure, and a plausible mechanism of action for aviptadil.

According to the FDA website, Fast Track designation is:

“a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.”

In the 15 months that followed the grant of Fast Track designation, we completed two clinical studies; a randomized controlled trial and an open-label trial that was recently published in peer-reviewed literature. We have also collected evidence of effectiveness in an expanded access program and additional evidence of safety from the ongoing NIH ACTIV-3b trial.

We believe that the additional data support the requirement and demonstrate preliminary evidence of efficacy, which is required for Breakthrough Therapy Designation.

According to the FDA website, Breakthrough Therapy Designation is:

“a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

The information we submitted to FDA on September 27, 2021, has previously been shared with the public in various preprints and peer-reviewed publications. However, the BTD application presents it in a unified manner that we think might be of interest. You can find the data we submitted in support of the BTD application on our website at: [LINK] AVIPTADIL – Application for Breakthrough Therapy Designation

FDA policy is to respond to our request within 60 days. However, please remember that Dr. Woodcock described the extraordinary workload at FDA because of the pandemic. Therefore, we hope the public will not infer anything, either way, if the review takes a bit longer.

Should FDA grant Breakthrough Therapy Designation to ZYESAMI, we would be afforded more frequent and detailed access to drug development guidance as we move towards filing a New Drug Application.  The Breakthrough Therapy program is not directly connected to the EUA program, so we do not know if one influences the other.

Thank you,

Jonathan

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