- The FDA issues a Complete Response Letter (CRL) to Repros Therapeutics (RPRX -33%) in response to its New Drug Application (NDA) seeking approval of enclomiphene citrate for the treatment of men with low testosterone due to secondary hypogonadism, a condition caused by insufficient stimulation of the testes by the pituitary gland.
- In the letter, the agency states, based on scientific developments, that the design of the Phase 3 studies supporting the NDA is no longer adequate to show clinical benefit and the company will need to conduct an additional study to support approval in the target population. It also includes concerns about study entry criteria, titration and bioanalytical method validation in the Phase 3 program.
- The company intends to work with the regulator to clarify a path forward that will address all its concerns. CEO Joe Podolski says, "We are disappointed that the FDA has taken this position without the benefit of an advisory committee recommendation. We plan to work closely with the agency to gain more information to determine the appropriate next steps regarding the enclomiphene application."
- Shares are down on more than triple normal volume.
- Previously: FDA action date approaches for Repros' Androxal (Nov. 27)