FDA Advisory Committee rejects NDA for Tlando a testosterone replacement therapy.

Lipocine Inc. announced that the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the "FDA" voted six in favor and thirteen against the benefit/risk profile of Tlando, the Company's oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The role of BRUDAC is to provide recommendations to the FDA. The FDA decision on whether or not to approve the Tlando New Drug Application is anticipated by the assigned Prescription Drug User Fee Act ("PDUFA") goal date of 8 May 2018.

The BRUDAC discussions were based on the NDA currently under review by the FDA. The NDA includes efficacy and safety data on Tlando including the results from three Phase III clinical trials: the Dosing Validation clinical study, the Dosing Flexibility clinical study and the Study of Oral Androgen Replacement clinical study. Lipocine resubmitted the NDA to the FDA in August 2017 based on the results of the DV study. The DV study confirmed the efficacy of Tlando with a fixed dose regimen without the need for dose adjustment. Tlando successfully met the FDA primary efficacy guidelines in the DV study safety statistical analysis set where 80% of the subjects achieved average testosterone levels within the normal range with a lower bound confidence interval of 72%. Tlando was well tolerated upon 52-week exposure with no reports of drug related Serious Adverse Events.

Comment- Two phase III trials showed Tlando moves average serum testosterone concentrations up into the normal range in most people. That result was enough for the studies to meet their primary endpoints. However the overall dataset failed to reduce fears about cardiovascular adverse events and the drug’s effect on blood pressure.