In response to the CRL, Lipocine proposed a dosing regimen based on analyses of existing data. The FDA noted that while Lipocines 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. About LPCN 1021 LPCN 1021 is a novel twice-a-day oral testosterone replacement therapy product candidate that is designed to help restore normal testosterone levels in hypogonadal men. Lipocine expects LPCN 1021 will help More hints fulfill an unmet need in the treatment of hypogonadism. The current testosterone market primarily uses short-acting injectable products as well as topical products that carry an FDA “black box” warning related to inadvertent transfer of testosterone to others. According to the IMS Health database, an average of half a million prescriptions a month have been dispensed so far in 2016 for TRT. About Lipocine Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies.
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