Repros Therapeutics Inc.
) announced that it has received guidance from the U.S. Food and
Drug Administration (FDA) related to the development of oral
Proellex for endometriosis and uterine fibroids.
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The FDA has allowed Repros to conduct phase I and phase II
studies on Proellex under two separate investigational new drug
(IND) applications for endometriosis and uterine fibroids.
However, the FDA maintained its partial clinical hold on
Proellex is being developed for severe endometriosis - a phase II
study is ongoing. The company is planning to submit the protocol
for a phase II study on Proellex for the treatment of symptomatic
The FDA also provided guidance related to the proposed uterine
fibroid phase II protocol. The FDA specified appropriate
enrollment criteria, preferred efficacy endpoint (reduction in
excessive menstrual bleeding associated with uterine fibroids)
and preferred methodology to determine changes in bleeding.
Repros plans to comply with the FDA guidance. We remind investors
that in 2009 data from a phase III efficacy study and phase III
safety studies revealed that Proellex (50 mg) was associated with
liver toxicity. Consequently, the company stopped these studies
and the FDA had placed a clinical hold on Proellex. On Oct 8,
2012, the FDA lifted the full clinical hold and placed a partial
clinical hold on low dose oral Proellex (12 mg).
Repros currently carries a Zacks Rank #4 (Sell). Some
better-ranked stocks include
Alexion Pharmaceuticals, Inc.
Gilead Sciences Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).