Soleno Therapeutics Provides Update on DCCR for the Treatment of PWS

FDA agrees to review additional data to determine adequacy for submission of NDA

Soleno Therapeutics, Inc. provided an update on Tuesday, July 7, 2021 following a recent interaction with the FDA regarding the development of DCCR, a potential treatment for PWS.

According to Soleno Therapeutics, on July 2, 2021 they received news from The FDA, following a meeting with them on June 11, 2021, that based on the data they have seen to date, an additional clinical trial is necessary for the submission of an NDA for DCCR. 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.


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