The U.S. Meals and Drug Administration (FDA) on Wednesday accredited Soleno Therapeutics, Inc.’s SLNO Vykat XR (diazoxide choline) extended-release tablets, beforehand known as DCCR, for hyperphagia in adults and kids 4 years of age and older with Prader-Willi syndrome (PWS).
Prader-Willi syndrome is a genetic situation characterised by hyperphagia (insatiable starvation) that impacts a toddler’s metabolism, physique, and conduct.
The corporate says Vykat XR is the primary accredited remedy to deal with hyperphagia in people with Prader-Willi syndrome.
Soleno expects Vykat XR to be accessible within the U.S. in April 2025.
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The FDA approval of Vykat XR was primarily based on an sufficient and well-controlled examine and security information from the excellent scientific growth program.
Efficacy was established throughout the 16-week randomized withdrawal examine interval of Research 2-RWP (Research C602-RWP), a Part 3 trial.
People randomized to change to placebo demonstrated a statistically vital worsening of hyperphagia (in contrast with people who remained on Vykat XR.
Vykat XR has a well-established security profile with over 4 years of information throughout 4 research.
Within the fourth-quarter earnings launch, the corporate stated it continued strengthening the business group in preparation for the anticipated U.S. launch of DCCR. Strategic investments in key business and medical affairs applications, together with illness state and payor schooling, information analytics, and assist infrastructure, are properly underway.
In November, the FDA prolonged the overview interval for the New Drug Software for DCCR (diazoxide choline) to March 27, 2025.
Worth Motion: SLNO inventory is up 37.8% at $67.50 throughout the premarket session on the final verify Thursday.
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