Soleno Therapeutics, Inc. has submitted a New Drug Application to the U.S. Food and Drug Administration for approval of DCCR extended-release tablets. This submission aims to treat Prader-Willi syndrome (PWS) in individuals aged four years and older who suffer from hyperphagia.

Soleno Therapeutics, emphasized the importance of this regulatory step for both Soleno and the PWS community. He highlighted that the NDA submission is a crucial milestone toward potentially offering a new treatment option for hyperphagia and other critical aspects of PWS. Soleno expressed gratitude to all stakeholders, including patients, families, investigators, and advocacy groups, for their contributions to DCCR's development.

DCCR has received Breakthrough and Fast Track designations in the U.S., along with Orphan Drug Designation for PWS in the U.S. and E.U. The FDA will review the NDA within 60 days to determine acceptance. Soleno has requested Priority Review, which could lead to a six-month review period post-acceptance.

Prader-Willi syndrome affects approximately one in 15,000 live births and is characterized by hyperphagia, along with behavioral issues and cognitive disabilities. Currently, there are no approved therapies targeting the appetite, metabolic, cognitive, or behavioral aspects of the disorder.

DCCR, an extended-release formulation of diazoxide choline, has shown promise in clinical trials for reducing hyperphagia and addressing other symptoms in individuals with PWS. The development program includes data from multiple Phase 1 and Phase 2 studies, supporting its potential therapeutic benefit in this patient population.

 

Source: globenewswire.com

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