BioCentury
ARTICLE | Clinical News

Proellex telapristone regulatory update

November 11, 2013 8:00 AM UTC

Repros said FDA provided guidance for the company's clinical program for low-dose oral Proellex telapristone to treat uterine fibroids, which the agency put on a full clinical hold in 2009. Repros said FDA provided guidance on acceptable endpoints for the treatment of uterine fibroids and instructed the biotech to submit a request for lifting the hold at the same time it submits a new protocol. The company said it will submit the protocol and request "in a timely fashion." Repros expects to start a clinical trial for oral Proellex and a Phase IIb trial for vaginal Proellex ( Proellex-V) in early 2014. In May, FDA recommended that Repros conduct a Phase IIb trial with Proellex-V before Phase III testing (see BioCentury, May 27). ...