Lipocine Announces Tentative Approval of TLANDO
SALT LAKE CITY, Dec. 8, 2020 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration (“FDA”) has granted tentative approval to TLANDO, its oral testosterone product for testosterone replacement therapy (“TRT”) in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). In granting tentative approval, the FDA has concluded that TLANDO has met all required quality, safety and efficacy standards necessary for approval, but TLANDO has not received final approval and is not eligible for final approval and marketing in the U.S. until the expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. with respect to Jatenzo®, which expires on March 27, 2022. Lipocine is currently reviewing FDA’s tentative approval of TLANDO and remains committed to taking appropriate actions with the goal of receiving final approval to permit the launch of TLANDO. The FDA has also required Lipocine to conduct certain post-marketing studies to (i) assess patient understanding of key risks relating to TLANDO and (ii) evaluate development of adrenal insufficiency with chronic TLANDO therapy.
“We are pleased to have received this tentative approval for TLANDO. The tentative approval is supported by a strong clinical and CMC data package. This is an important step towards getting our oral TRT no-titration option to patients. We are committed to working towards obtaining final approval of TLANDO,” said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. Dr. Patel further stated, “We believe that TLANDO represents a differentiated TRT for treating hypogonadism in men, with the potential to both improve patient compliance and overcome inadvertent testosterone transference and pulmonary oil micro-embolism risks, effects often associated with existing non-oral treatments.”
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 LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study. 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 cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate 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.
This release contains “forward-looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding the timing and receipt of final approval of TLANDO, the expiration of exclusivity rights of third party products, the timing of completion of clinical trials and other studies, the regulatory approval process of our product candidates, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not grant final approval for TLANDO, that the FDA will not approve any of our products, risks related to exclusivity granted by the FDA to competing products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.
SOURCE Lipocine Inc.
Posted: December 2020
- Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA – November 11, 2019
- Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019 – May 14, 2019
- Lipocine Receives Complete Response Letter for Tlando From U.S. Food and Drug Administration – May 9, 2018
- Lipocine Announces Outcome of FDA Advisory Committee Meeting for Tlando, Testosterone Replacement Therapy in Adult Males with Hypogonadism – January 10, 2018
- Lipocine Announces FDA Acknowledgement of Tlando (LPCN 1021) NDA Resubmission – August 14, 2017
- Lipocine Resubmits NDA for Its Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism – August 9, 2017
- Lipocine Receives Complete Response Letter (CRL) for LPCN 1021 From U.S. FDA – June 29, 2016
- Lipocine Announces PDUFA Goal Date for LPCN 1021 NDA – November 12, 2015
- FDA Accepts for Filing Lipocine’s NDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021 – October 29, 2015
- Lipocine Submits NDA to FDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021 – August 31, 2015
Tlando (testosterone) FDA Approval History
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