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Lipocine Announces Regulatory Path Forward for TLANDO™ Resubmission
SALT LAKE CITY, Feb. 24, 2020 /PRNewswire/ -- Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders,
About this update from Lipocine Inc.
[{"type":"text","content":"SALT LAKE CITY, Feb. 24, 2020 /PRNewswire/ -- Lipocine Inc. (LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the results of its Post Action meeting with the U.S. Food and Drug Administration (\"FDA') regarding its New Drug Application (\"NDA\") for TLANDO™, 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. Based on the Post Action meeting and written feedback, the FDA indicated Lipocine's approach to addressing the single remaining deficiency through the reanalysis of existing data in accordance with FDA feedback appears to be a reasonable path forward. The FDA requested that the information generated by the reanalysis be submitted as part of an NDA resubmission with a six-month Prescription Drug User Fee Act (\"PDUFA\") clock. \n\n \n \n\n \n\"We are committed to working closely with the FDA towards the goal of achieving approval of TLANDO, our fixed-dose oral TRT,\" said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. \"We plan to submit the TLANDO NDA in the first quarter of 2020.\"\nAbout LipocineLipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes TLANDO, LPCN 1144, TLANDO XR (\"LPCN 1111\"), LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine received a complete response letter from the FDA related to TLANDO on November 8, 2019. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of pre-cirrhotic NASH. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone tar...