Benzinga | Jul 6, 2021 08:06AM EDT

Soleno Therapeutics Says On Jul. 2 Received Official meeting Minutes From Type B FDA Meeting; FDA Continued To Assert That Based On Data, Additional Trial Is Necessary For NDA But Encouraged Co. To Submit Available Data

Soleno Therapeutics, Inc. ("Soleno") (NASDAQ:SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided an update following a recent interaction with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi Syndrome (PWS).



On July 2, 2021, the Company received official meeting minutes from the June 11th, 2021, Type B meeting with the Division of Diabetes, Lipids and Obesity. Included in the meeting was the "patient voice" represented by the PWS advocacy organizations, as well as the family of a DCCR trial participant. The FDA continued to assert that based on the data they have seen to date, an additional clinical trial is necessary for the submission of a New Drug Application (NDA). However, the FDA strongly encouraged Soleno to submit the available data and clinical study reports for the Company's Phase 3 trial, DESTINY PWS (C601), and its long-term, open-label extension study (C602) to allow them to assess if these studies may provide adequate evidence of safety and efficacy to support the submission of an NDA.

"We are continuing our dialogue with the FDA and remain focused on our goal of achieving approval for DCCR for the treatment of PWS," said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. "We appreciate the opportunity to include the patient voice in our discussions with the Division. We intend to submit additional data from DESTINY PWS and the C602 extension study to the Agency before the end of the third quarter. The FDA has agreed to review these data to determine if the totality of data generated to date are sufficient to support a potential NDA submission."