Lipocine’s Male Hormone Therapy Stumbles With FDA For The Third Time

Lipocine said Monday the FDA said “nay” for the third time for its Tlando, an oral testosterone replacement therapy for use in adult males for treating conditions associated with hypogonadism, which is a deficiency of endogenous testosterone. The complete response letter, or CRL, issued by the FDA signaling the application cannot be approved in the present form, pointed to one deficiency — the efficacy trial not meeting the three secondary endpoints for maximal testosterone concentration. Lipocine initially submitted the NDA for Tlando back in 2015, although the FDA shot down the application the very next year on the grounds that there were deficiencies related to the dosing algorithm for the label.