Treatment for Hypogonadism, Male
Lipocine Announces PDUFA Goal Date for LPCN 1021 NDA
SALT LAKE CITY, Nov. 12, 2015 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has assigned a Prescription Drug User Fee Act ("PDUFA") goal date of June 28, 2016 for completion of the review of the 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 ("hypogonadism"). Additionally, the 74-day filing communication letter did not mention a need to convene an Advisory Committee for advice on the NDA for LPCN 1021 and we confirmed in subsequent communication with the FDA that an Advisory Committee is not planned.
About LPCN 1021
LPCN 1021 is a novel twice-a-day, oral testosterone replacement therapy product candidate with three simple oral dosing options that Lipocine expects will overcome the major shortcomings of existing products. The current testosterone market is dominated by topical products that carry FDA "black box" warnings related to inadvertent transfer of testosterone and by injectable products. The IMS Health database shows that an average of half a million prescriptions a month has been dispensed so far in 2015 for TRT.
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. LPCN 1021 demonstrated positive efficacy and safety results in Phase 3 testing, is targeted for testosterone replacement therapy and has a NDA under review with the FDA. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone replacement therapy product with once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth with orphan drug designation, that is currently in Phase 1 testing.
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 relating to expectations regarding the FDA review process relating to our NDA for LPCN 1021 and the outcome of such process, clinical trials, the potential uses and benefits of Lipocine's product candidates, product development and commercialization efforts and the projected timing and outcome of regulatory filings and actions. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks related to our products, expected product benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, risks related to the FDA's review of our NDA for LPCN 1021, the receipt of regulatory approvals, the results 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 U.S. Securities and Exchange Commission (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 Company's website at www.lipocine.com or 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: November 2015
- FDA Approves Tlando (testosterone undecanoate) for Male Hypogonadism - March 29, 2022
- Lipocine Announces FDA Affirmation Of Class 1 NDA Resubmission For TLANDO® - September 28, 2021
- Lipocine Announces Tentative Approval of TLANDO - December 8, 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
- 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
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.