Lipocine resubmits NDA for LPCN 1021
Lipocine announced the resubmission of a New Drug Application, or NDA, for LPCN 1021, its oral testosterone product candidate for testosterone replacement therapy, or TRT, in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. Lipocine had previously submitted an NDA for LPCN 1021 and received a Complete Response Letter, or CRL, from the FDA in June 2016. The CRL identified a deficiency related to the dosing algorithm for the proposed label. With the goal of addressing this deficiency, the company successfully completed a dosing validation study, which confirmed the validity of a fixed dose approach without the need for dose titration to orally administer LPCN 1021. The efficacy results of the DV study, as well as an integrated safety set from all previously conducted clinical trials, including 52-week safety results from the Phase 3 Study of Androgen Replacement clinical study, form the basis for the NDA resubmission.