Lipocine Inc. issued the following announcement on April 17.
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the United States Food and Drug Administration ("FDA") denied the Citizen Petition filed by Clarus Therapeutics Inc. ("Clarus") on October 2, 2019. Specifically, the FDA declined to issue product-specific guidance on oral T-ester drug products and denied without comment Clarus' request regarding how the FDA should review and make approval decisions on any pending or future oral T-ester products.
Clarus originally filed the Citizens Petition with the FDA requesting the FDA issue "clear, written guidance regarding the safety and efficacy standards required for oral testosterone-ester prodrugs as testosterone replacement therapy" and requested the FDA not to approve "any pending [new drug application ("NDA")] for an oral T-ester to treat male hypogonadism that fails to meet the standards for approval set forth in [the] petition."
About Lipocine
Lipocine 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 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 has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. 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 targeted for the treatment of NASH cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. For more information, please visit www.lipocine.com.
Original source can be found here.
