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# Soleno Study Change Might Answer Questions: FDA
- URL: https://www.fdaweb.com/soleno-study-change-might-answer-questions-fda/
- Published: 2022-07-20T12:00:00.000Z
- Updated: 2026-09-14T17:52:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152323

FDA has told Soleno Therapeutics that a proposed change to the company’s study of DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi syndrome might address the agency’s concerns about the adequacy of the overall efficacy data supporting an NDA. Soleno [says](https://investors.soleno.life/news-releases/news-release-details/soleno-therapeutics-provides-regulatory-update-dccr-treatment-3?ref=fdaweb.com) the study protocol has been amended to include the randomized withdrawal period it had proposed to FDA. The randomized withdrawal phase would consist only of participants currently enrolled in the study and not include any new patients, it says.

Soleno says it is continuing to work with FDA to finalize specific details of the study design.