SALT LAKE CITY, Nov. 11, 2015 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that clinical data 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”), will be presented at the 21st Annual Meeting of the Sexual Medicine Society of North America (SMSNA) in Las Vegas, NV.
Presentation/poster details are as follows:
Title: Dose Titration and Safety of Oral Testosterone (LPCN 1021) in Hypogonadal Men:
Results from the SOAR Study (#030)
Date: November 20th
Time: 3:15 pm PST (Poster: 3:00 - 4:00 pm PST)
Presenter: Mohit Khera, MD
Associate Professor,
Urology
Baylor College of Medicine
Houston, TX, US
Director, Laboratory for Andrology Research
Medical Director, Houston Hospital for Specialized Surgery
Title: Assessment of Fasting and Varying Meal Fat Content on the Bioavailability of
Testosterone from Oral Testosterone Undecanoate (LPCN 1021) in Hypogonadal Men
(#036)
Date: November 20th
Time: 3:45 pm PST (Poster: 3:00 - 4:00 pm PST)
Presenter: Mohit Khera, MD
Title: Efficacy and Pharmacokinetics of Oral Testosterone (LPCN 1021) in Hypogonadal Men
(#028)
Date: November 20th
Time: 3:05 pm PST (Poster: 3:00 - 4:00 pm PST)
Presenter: Irwin Goldstein, MD
Director, San Diego Sexual Medicine
Director, Sexual Medicine, Alvarado Hospital, San Diego, CA
Clinical Professor of Surgery, University of California at San Diego
Editor-in-Chief, Sexual Medicine Reviews
President-Elect, International Society for the Study of Women’s Sexual Health
Editor Emeritus, The Journal of Sexual Medicine
Editor Emeritus, International Journal of Impotence Research
About LPCN 1021
LPCN 1021 is a 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 have been dispensed so far in 2015 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. A New Drug Application was filed with the FDA for Lipocine’s lead product candidate, LPCN 1021. LPCN 1021 demonstrated positive efficacy and safety results in Phase 3 testing and is targeted for testosterone replacement therapy. 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, is currently in Phase 1 testing.
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