Repros Therapeutics settles with creditors, new hope for Androxal FDA approval.

"The creditor settlement is an important first step in addressing our balance sheet issues and allows us to continue our Androxal® program for the immediate future while we pursue additional financing and strategic options. We have recently submitted a request for a Type C meeting with the FDA to discuss our latest findings for Androxal."

Mr. Podolski continued: "We hope to determine with the FDA whether the
previously reported preservation of fertility while being treated for secondary hypogonadism is a clinically relevant outcome which would allow for a clear clinical path for Androxal, an oral treatment that restores testicular function. There can be no assurances that the FDA will deem fertility preservation during treatment as clinically relevant and sufficient to support efficacy of the drug.

Previously Repros showed Androxal to be non inferior to Androgel when comparing circulating testosterone levels. Androgel is a topical testosterone gel and the leading testosterone treatment with reported US sales of over $400 million. Unlike Androgel or exogenous testosterone treatments in general, Androxal does not suppress the hypothalamic-pituitary-testes axis as evidenced by secretion of normal pituitary hormones as well as normalization of testicular production of testosterone and sperm when hypogonadal men are administered Androxal."

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