Recently, the US Food and Drug Administration (FDA)
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
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.
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
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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
Repors carries a Zacks Rank #4 (Sell). In the pharma/biopharma
space, companies that currently look well-positioned include
Salix Pharmaceuticals, Ltd.
). All three are Zacks Rank #1 (Strong Buy) stocks.