> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Soleno Needs Another Trial for NDA Filing: FDA
- URL: https://www.fdaweb.com/soleno-needs-another-trial-for-nda-filing-fda/
- Published: 2022-01-25T12:00:00.000Z
- Updated: 2026-09-14T17:29:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150999

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). Soleno says that recent meeting minutes from a 12/21/2021 Type C meeting with CDER’s Division of Psychiatry indicated the agency was “receptive to a study design involving participants currently enrolled in Study C602, the company’s ongoing open-label extension study to generate the additional control data necessary to support an NDA.” Study C602 comprises patients who completed DESTINY PWS, an international, multi-center, randomized, double-blind, placebo-controlled study of DCCR. The company expects to submit a study proposal shortly and, if acceptable, intends to begin it soon after.  

“We appreciate the constructive dialog with the FDA and the potential to obtain additional controlled clinical data from participants already enrolled in C602,” Soleno says. “This approach would significantly reduce the time and cost to obtain the necessary data. Importantly, we are continuing our preparations for an NDA submission for DCCR while the additional data are being collected.”

According to the company, the Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births in the U.S. The disorder is characterized by hyperphagia, a chronic feeling of insatiable hunger that severely diminishes quality of life. Additional characteristics include behavioral problems, cognitive disabilities, low muscle tone, short stature, the accumulation of excess body fat, developmental delays, and incomplete sexual development.