Lipocine announced that the Food and Drug Administration (FDA)’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted 6 in favor and 13 against the benefit/risk profile of Tlando (testosterone undecanoate) capsules, an oral testosterone product candidate for testosterone replacement therapy in adult males with primary hypogonadism or hypogonadotropic hypogonadism.
The Tlando New Drug Application (NDA) included safety and efficacy data from three Phase 3 trials: the Dosing Validation (DV) study, the Dosing Flexibility (DF) study, and the Study of Oral Androgen Replacement (SOAR) study. The NDA was resubmitted in August 2017 following the results of the DV study that confirmed the efficacy of Tlando as a fixed-dose regimen without the need for dose adjustment.
In the DV analysis (N=95), Tlando met the federal primary efficacy guidelines with 80% of study patients achieving average testosterone levels within normal range with a lower bound confidence interval of 72%. In addition, treatment with Tlando was was well tolerated over a period of 52 weeks; there were no reports of serious adverse events.
Safety concerns cited during the meeting included effects of Tlando on blood pressure and heart rate, hematocrit, and serum lipids.
Tlando capsules contain 112.5mg testosterone undecanoate, an esterified testosterone derivative, combined with a proprietary lipid formulation. Following oral administration, testosterone undecanoate is systemically absorbed primarily by the lymphatic system.
The recommendations by BRUDAC are non-binding and the FDA decision on approval is anticipated by the Prescription Drug User Fee Act (PDUFA) target date of May 8, 2018.
For more information call (801) 994-7383 or visit Lipocine.com.