US orphan status for EffRx' EX404 for pediatric polycystic ovary syndrome

Swiss drug delivery specialist EffRx Pharmaceuticals says the US Food and Drug Administration has granted orphan drug designation to its proprietary metformin-based product candidate, EX404, for the treatment of pediatric polycystic ovary syndrome (PCOS).

"The FDA's Orphan Drug designation of EX404 is a significant step forward in our clinical development program. PCOS is a serious problem among women of reproductive age and there is a clear, unmet need for treatments targeting the pediatric and adolescent patient population," said Christer Rosen, EffRx chairman and chief executive.

Clinical trial initiation expected this fall