FDA Gives “Thumbs Down” to Oral Testosterone Therapy

Agency questions dosing algorithm

Lipocine, Inc., has received a complete response letter (CRL) from the FDA regarding its new drug application for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (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 LPCN 1021 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.

Lipocine plans to request a meeting with the FDA to agree on a path forward to achieve approval of LPCN 1021.

LPCN 1021 is a twice-a-day oral testosterone replacement therapy product candidate that is designed to help restore normal testosterone levels in hypogonadal men.

The current testosterone market primarily uses short-acting injectable products as well as topical products that carry an FDA boxed warning related to inadvertent transfer of testosterone to others. According to the IMS Health database, an average of half a million prescriptions a month have been dispensed in 2016 for testosterone replacement therapy.

Source: Lipocine; June 29, 2016.