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# FDA Seeks Additional Trial Before Soleno NDA Filing
- URL: https://www.fdaweb.com/fda-seeks-additional-trial-before-soleno-nda-filing/
- Published: 2021-07-06T12:00:00.000Z
- Updated: 2026-09-14T17:05:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149642

FDA has told Soleno Therapeutics that an additional clinical trial is necessary before the company submits an NDA for once-daily DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi Syndrome (PWS). CDER’s Division of Diabetes, Lipids and Obesity said that based on data it has seen to date, an additional clinical trial is necessary. However, it strongly encouraged Soleno to submit available data and clinical study reports from the Phase 3 DESTINY PWS (C601) trial, and its long-term, open-label extension study (C602) to allow reviewers to assess if these studies may provide adequate safety and efficacy evidence to support an NDA, according to Soleno. It plans to submit the requested data before the end of the current quarter.