LPCN 1021 regulatory update

FDA issued a complete response letter to Lipocine for an NDA for LPCN 1021 as testosterone replacement therapy in patients with hypogonadism. Lipocine said FDA identified problems with the company’s proposed dose titration scheme for clinical practice, which “significantly differed” from the scheme used in a Phase III trial. Lipocine plans to meet with the agency to discuss a path forward for approval of LPCN 1021. ...