- Primary endpoint of induction of amenorrhea met for both pooled oral and vaginal delivery compared to placebo, p<0.0001 and p=0.0071, respectively
- Statistically significant reduction in fibroid size from baseline achieved by the combined active arms for the pooled oral dosage form compared to placebo, p=0.0004
- Statistically significant improvement in Uterine Fibroid Symptom Severity Score (UFSQOL) achieved for the pooled oral dosage form compared to placebo, p=0.0211
- On the basis of a comparison of oral and vaginal delivery systems, the Company will propose the oral route of administration for Phase 3 development
- The Company plans to submit a request to the FDA before the end of 2016 to discuss the Phase 3 program
Joseph Podolski, President and CEO of Repros, commented, "We believe the benefit:risk profile of Proellex ® could afford a significant advantage over GnRH agonists and antagonists in the treatment of uterine fibroids. The longer treatment period and apparent improvement in efficacy based on the incidence of amenorrhea compared to other selective progesterone antagonists is also encouraging."The Company plans to request, before the end of this year, a meeting with the FDA to discuss Phase 3 development of the oral dosage form. About Repros Therapeutics Inc. ® Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders. Forward-Looking Statements 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 FDA, possible submission of one or more NDAs and the commercial potential of Proellex ®, risks relating to the Company's ability to protect its intellectual property rights and such other risks as are identified in the Company's most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For more information, please visit the Company's website at http://www.reprosrx.com.
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