Medicus Pharma advances Phase 2 study following FDA and IRB feedback

Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive Medicus Pharma CEO Dr. Raza Bokhari joined Steve Darling from Proactive to discuss the company's receipt of written FDA feedback and central Institutional Review Board (IRB) approval, with modifications, for its optimized Phase 2 clinical trial evaluating Teverelix® in men following a first episode of acute urinary retention (AUR). Bokhari said the randomized, double-blind, placebo-controlled, multicenter study, designated ANT-2111-02, will enroll approximately 126 patients to evaluate the effects of Teverelix DP, a long-acting GnRH antagonist, on prostate volume and urinary function after an initial episode of AUR. The FDA provided seven recommendations related to protocol implementation, safety monitoring, and study documentation, including updates to contraception reporting, injection-site blinding, alpha-blocker therapy tracking, race data collection, and clarification of a secondary endpoint. Importantly...