Recently, the US Food and Drug Administration (FDA) recommended Repros Therapeutics Inc. to conduct a phase IIb trial on its pipeline candidate, Proellex-V before commencing phase III studies.
The primary indication and label for Proellex-V, as agreed upon by Repros and the FDA, will be treatment of severe menstrual bleeding associated with uterine fibroids. Repros plans to initiate the phase IIb trial in the second half of 2013. Data from the study is expected in mid-2014. Pictorial Blood Loss Assessment (PBAC) was identified as the primary endpoint of this trial.
The company believes the Proellex-V provides relief from the bulk symptoms associated with uterine fibroids. Repros identifies this as a key advantage and believes that the inclusion of such claim would provide it with an edge while marketing the drug.
The FDA has recommended one-year pivotal studies for Proellex-V in uterine fibroids indication. Repros plans to conduct a one-year safety study as well and submit regulatory application for the drug to the FDA in 2016.
We note that in Jan 2013, the company reported top line results from a phase II trial evaluating the use of Proellex-V for the treatment of symptomatic fibroids. The results from the study suggested that Proellex-V at 12 mg dose may provide benefit to the patients.
Repors carries a Zacks Rank #4 (Sell). In the pharma/biopharma space, companies that currently look well-positioned include Salix Pharmaceuticals, Ltd. , Santarus, Inc. and Jazz Pharmaceuticals (JAZZ - Free Report) . All three are Zacks Rank #1 (Strong Buy) stocks.