Soleno Therapeutics Receives FDA Extension for DCCR Review

Soleno Therapeutics, Inc. made public on November 26, 2024, that the U.S. Food and Drug Administration (FDA) has lengthened the review period for the New Drug Application (NDA) concerning DCCR (diazoxide choline) extended-release tablets. Initially set for December 27, 2024, the new target action date for this review is now March 27, 2025.

The extension was necessary due to responses to recent information requests that constituted a major amendment to the NDA. This extra time will enable the FDA to thoroughly evaluate the additional information submitted. Importantly, in their correspondence, the FDA did not raise any concerns regarding safety, effectiveness, or manufacturing processes.

Soleno Therapeutics submitted the NDA to the FDA on June 27, 2024, and received Priority Review status in August 2024. DCCR (diazoxide choline) has been granted significant designations including Breakthrough and Fast Track Designations in the U.S., as well as Orphan Drug Designations in both the U.S. and E.U. for treating patients with Prader-Willi syndrome (PWS).

PWS is a rare genetic disorder that affects approximately one in every 15,000 live births. It is characterized by symptoms such as hyperphagia, cognitive disabilities, and behavioral issues. Hyperphagia, the hallmark symptom, presents as an insatiable hunger, leading to severe health risks and a diminished quality of life. Currently, there are no approved therapies targeting the various aspects of this disorder.

DCCR, a novel extended-release tablet formulation of diazoxide choline, has shown promise in addressing hyperphagia and other symptoms in individuals with PWS. The therapeutic potential of DCCR is supported by data from multiple clinical studies.

Soleno Therapeutics, Inc. is dedicated to developing and commercializing innovative therapeutics for rare diseases. The ongoing NDA review of DCCR for the treatment of PWS underscores the company’s commitment to addressing unmet medical needs. For further information, interested parties can visit Soleno’s website at www.soleno.life.

This announcement contains forward-looking statements that involve known and unknown risks and uncertainties, which could lead to actual results differing materially from those expressed or implied. It is recommended that interested parties review the company’s filings with the SEC for a comprehensive understanding of the associated risks. The company does not intend to publicly update or revise any forward-looking statements unless required by law.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Soleno Therapeutics’s 8K filing here.

About Soleno Therapeutics

Soleno Therapeutics, Inc, a clinical-stage biopharmaceutical company, focuses on the development and commercialization of novel therapeutics for the treatment of rare diseases. Its lead candidate is Diazoxide Choline Extended-Release tablets, a once-daily oral tablet, which is in Phase III clinical trials for the treatment of Prader-Willi Syndrome.