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FDA Grants End of Phase 2 Meeting to Discuss Phase 3 Requirements for Oral Proellex® in the Treatment of Uterine Fibroids
In the Phase 2 study, leading up to the meeting request, Proellex® successfully induced amenorrhea (cessation of menses) in greater than 90% (LOCF, p-value < 0.0001 pooled 6 and 12 mg doses compared to placebo) of subjects after two 18 week treatment cycles separated by an off drug interval to allow for menstruation. Subject's improvement in the Uterine Fibroid Symptom Severity Score from the UFSQOL questionnaire was statistically better for those treated with Proellex® (LOCF, p = 0.0038).
The study was conducted in the US with the average age of study participants > 40 years of age, with a body mass index > 30 and over 90% of the subjects were
The drug was generally well tolerated.
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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