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Repros Requests Meeting With FDA to Discuss Phase 3 Requirements for Proellex® in the Treatment of Endometriosis
In previous studies of women with severe endometriosis, Proellex® not only significantly reduced pelvic abdominal pain associated with menses, the primary pain associated with endometriosis, it also reduced the need for analgesics compared to placebo. In a recently completed Phase 2 study, final results showed a 55% reduction in total pill count of non-prescription and prescription analgesics in the Proellex®-treated arms, while placebo-treated subjects only experienced a reduction of 30% (p = 0.0619). This is encouraging given the small size of the study, 43 on either 6 or 12 mg Proellex® and 17 on placebo.
The Company has previously requested a meeting with the
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as
"may," "will," "expect," "anticipate," "continue," "estimate," "project," "intend," "believe," "plan," "seek," "could," "can," "should" or similar expressions. These statements are based on assumptions that the Company has made in light of the Company's experience in the industry, as well as the Company's perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to ongoing and future clinical studies and the timing and results thereof, the Company's plans to communicate with the
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