BRUDAC’s panel voted six in favor and thirteen against the benefit/risk profile of the company’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.
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 ("NDA") is anticipated by the assigned Prescription Drug User Fee Act ("PDUFA") goal date of May 8, 2018.
Lipocine chairman, president and CEO Mahesh Patel said: "We continue to believe that efficacy and safety results from numerous clinical studies with TLANDO are consistent with other FDA approved TRT products.
"We look forward to continuing to work with the FDA through the remainder of the review process."
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 3 clinical trials: the Dosing Validation ("DV") clinical study, the Dosing Flexibility ("DF") clinical study and the Study of Oral Androgen Replacement ("SOAR") 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 ("SS") where 80% of the subjects achieved average testosterone levels ("Cavg") within the normal range with a lower bound confidence interval ("CI") of 72%. TLANDO was well tolerated upon 52-week exposure with no reports of drug related Serious Adverse Events ("SAEs").
Although the FDA will consider the recommendation of BRUDAC, the final decision regarding the approval of TLANDO is made by the FDA solely, and the recommendations by BRUDAC are non-binding.