Soleno Therapeutics (SLNO) said Tuesday the US Food and Drug Administration has extended its review period for the New Drug Application of DCCR by three months after determining that recent responses to the FDA's information requests represent a "major amendment."
The company said the FDA, which set a new target action date of March 27, did not raise concerns about the drug's safety, efficacy, or manufacturing.
The NDA, submitted in June and accepted with priority review in August, seeks approval for diazoxide choline extended-release tablets, known as DCCR, for the treatment of hyperphagia in individuals aged four and older with Prader-Willi syndrome, Soleno said.
Diazoxide choline has previously received Breakthrough and Fast Track designations in the US, and the Orphan Drug designation in the US and EU, the company added.
Shares of the company were down more than 5% in recent Tuesday premarket activity.
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