September 25, 2017 / 12:31 PM / a year ago

BRIEF-Soleno Therapeutics receives scientific advice from EMA

Sept 25 (Reuters) - Soleno Therapeutics Inc

* Soleno Therapeutics says ‍has received scientific advice from CHMP of European Medicines Agency regarding diazoxide choline controlled-release for treatment of prader-willi syndrome

* Soleno THERAPEUTICS INC says ‍EMA indicated that a single pivotal trial would support a marketing authorisation application for DCCR in Prader-Willi syndrome​

* Soleno Therapeutics Inc says ‍EMA also indicated their general acceptance of several key aspects of proposed development plan​

* Says ‍EMA expressed their support for change in hyperphagia compared to placebo as primary endpoint for study​

* Says ‍EMA also commented that soleno could treat children with hyperphagia in study without further toxicology work​

* Says ‍looks forward to initiating Phase III program for DCCR before end of 2017​ Source text for Eikon: Further company coverage:

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