Lipocine Inc. announced the completion of a Post Action meeting with the U.S. Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The purpose of the meeting was to review the Complete Response Letter ("CRL") and to determine actions needed to achieve approval of LPCN 1021.
The CRL, issued June 28, 2016, identified deficiencies related to the dosing algorithm for the label. In response to the CRL, Lipocine proposed a dosing regimen based on analyses of existing data. The FDA noted that while Lipocine's proposed dosing regimen might be acceptable, validation in a clinical trial would be needed prior to resubmission.
As a result, Lipocine has submitted the new dosing validation clinical study protocol to the FDA and the FDA has agreed to review the protocol through a Special Protocol Assessment ("SPA"). An SPA is an advanced declaration from the FDA that a planned trial's design, clinical endpoints, and statistical analyses could potentially result in data acceptable for FDA review towards approval for the proposed indication.
"We were pleased to have had a very productive meeting with the FDA with a path identified to bring our NDA for LPCN 1021 into a position for approval," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine. "We remain committed to bring LPCN 1021 to the market."
