Soleno Concludes Type C Meeting With FDA For Diazoxide Choline In Prader-Willi Syndrome

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Soleno Therapeutics Inc SLNO said that on January 20, 2022, the Company received official meeting minutes from the Type C meeting with the FDA's Division of Psychiatry. 

  • The purpose of the meeting was to discuss the adequacy of the data submitted by Soleno to the FDA and possible ways to generate additional controlled clinical data for DCCR (diazoxide choline) extended-release tablets for Prader-Willi syndrome (PWS).
  • Related: Soleno Therapeutics' DCCR Shows Benefit On Hunger, Behavioral Parameters.
  • The FDA indicated they were receptive to a study design involving enrolled participants in Study C602, Soleno's ongoing open-label extension study, to generate the additional control data necessary to support a marketing application. 
  • The Company expects to submit a study proposal shortly and, if acceptable, intends to initiate the study after that.
  • "We appreciate the constructive dialogue with the FDA and the potential to obtain additional controlled clinical data from participants already enrolled in C602. This approach would significantly reduce the time and cost to obtain the necessary data," said Anish Bhatnagar, CEO.
  • Price Action: SLNO shares are down 6.17% at $0.35 during the premarket session on the last check Monday.
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