Proellex-V regulatory update

Repros said FDA recommended that it conduct a Phase IIb trial for Proellex-V to treat uterine fibroids before Phase III testing. The Phase IIb trial will start next half, with data expected in mid-2014. Repros also said it and FDA agreed that the primary indication for Proellex-V should be treatment of severe menstrual bleeding associated with uterine fibroids and that the primary endpoint for the trial will be Pictorial Blood Loss Assessment (PBAC). Additionally, Repros must validate any label claim based on a patient reported outcome (PRO) before the start of Phase III testing. FDA said the pivotal trials should be 1 year in duration. Repros expects to submit an NDA for the vaginally delivered selective progesterone receptor modulator (SPRM) in 2016. ...