Lipocine Divulges TLANDO Profile examined by Advisory Committees of FDA for Hypogonadism
After the Bone, Reproductive and Urologic Drugs Advisory Committee (“BRUDAC”) of the U.S. Food and Drug Administration (“FDA”) voted six in favor and thirteen against the benefit/risk profile of TLANDO, Lipocine’s 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 setting the stage for sanctioning the TLANDO New Drug Application assigned by the Prescription Drug User Fee Act (“PDUFA”) goal date of May 8, 2018.
Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine said”We look forward to continuing to work with the FDA through the remainder of the review process.”
The application includes efficacy and safety data on TLANDO including the results from three Phase 3 clinical trials: the Dosing Validation clinical study, the Dosing Flexibility clinical study and the Study of Oral Androgen Replacement clinical study. The dosing Validation study promulgated the efficacy of TLANDO with a fixed dose regimen without entailing dose adjustment. TLANDO successfully fulfilled 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 witnessed high tolerance levels upon 52-week exposure with no reports of adverse drug related cases.