Lipocine Gets CRL From FDA For LPCN 1021 - Quick Facts

(RTTNews) - Lipocine Inc. (LPCN) said that it has received a Complete Response Letter or "CRL" from the United States Food and Drug Administration regarding its New Drug Application or "NDA" for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy or "TRT" in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form.

The CRL identified deficiencies related to the dosing algorithm for the label. Specifically, the proposed titration scheme for clinical practice was significantly different from the titration scheme used in the Phase 3 trial leading to discordance in titration decisions between the Phase 3 trial and real-world clinical practice.

The company noted that the next step will be to request a meeting with the FDA to understand more fully the issues raised and to agree on a path forward to achieve approval of LPCN 1021.