Research & Development
Lipocine Inc updates US FDA's BRUDAC Advisory Committee meeting outcome of the hypogonadism testosterone replacement TLANDO therapy
11 January 2018 -

Pharmaceutical company Lipocine Inc (NASDAQ:LPCN) Wednesday provided the voting outcome of US FDA's BRUDAC Advisory Committee meeting of the adult males hypogonadism testosterone replacement therapy, the TLANDO.

The company said the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) of the US Food and Drug Administration (FDA) voted six in favor and 13 against the benefit/risk profile of TLANDO, the oral testosterone product candidate for testosterone replacement therapy (TRT) in adult males.

According to the company, TLANDO is its 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.

In conjunction, the US FDA's 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 8 May 2018, added the company.

TLANDO's NDA includes efficacy and safety data from 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. The company resubmitted the NDA to the US FDA based on the results of the DV study.

Additionally, the company's DV study confirmed the efficacy of TLANDO with a fixed dose regimen without the need for dose adjustment. TLANDO successfully met the US 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 (CI) of 72%. TLANDO was well tolerated upon 52-week exposure with no reports of drug related serious adverse events.