FDA finds deficiencies in Lipocine NDA

Shares of US drugmaker Lipocine (Nasdaq: LPCN) tumbled more than 32% to $1.20 in premarket trading today, after the company revealed that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration.

The CRL relates to Lipocine’s New Drug Application (NDA) for Tlando, its oral testosterone product candidate for testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

The CRL identified four deficiencies which include the following: determining the extent, if any, of ex vivo conversion of testosterone undecanoate (TU) to testosterone (T) in serum blood collection tubes to confirm the reliability of T data; obtaining definitive evidence pre-approval via an ambulatory blood pressure monitoring study as to whether Tlando causes a clinically meaningful increase in blood pressure in hypogonadal men; verifying the reliability of Cmax data and providing justification for non-applicability of the agreed-upon and pre-specified Cmax secondary endpoints for Tlando, and, determining the appropriate stopping criteria that can reproducibly and accurately identify those patients who should discontinue use of Tlando.