Repros Therapeutics Inc. said Monday it obtained positive written feedback from the Division of Reproductive and Urologic Products regarding its drug candidate Androxal.
In a written advice letter to the company, the FDA said, it agreed to the company’s proposal to conduct two Phase 3 placebo and active controlled studies to demonstrate the benefit of enclomiphene in fertile hypogonadal men with normal gonadotropin levels. The agency added that the final protocols for the Phase 2 and Phase 3 studies should be submitted to the division for review.
Repros noted that the regulatory body agreed with the company’s indication statement for the use of Androxal in the treatment of secondary hypogonadism in men wishing to preserve fertility.
The agency, in its written statement, added, “We recommend enrolling only those subjects with morning serum total testosterone levels below 250 ng/dl on two assessments performed at least one week apart to ensure that the majority of enrolled subjects have true hypogonadism warranting therapy.”
The Company believes the FDA’s comments are appropriate and will address them in the protocol that is being drafted, and said it would submit a Phase II protocol to determine a minimum effective dose when it submits its Phase III protocols to the FDA.
Joseph Podolski, Repros President and CEO, commented, “Gaining FDA agreement to the fertility preserving indication for Androxal is an important step in the development of the drug. We believe that Androxal, if eventually approved, can provide an important new drug therapy for men seeking treatment for their hypogonadal state.”