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Clarus Therapeutics to Present Phase 3 Data for Rextoro(R) at ICE/ENDO 2014
Poster Presentations to Highlight Safety, Efficacy and Dosing Data for Clarus' Testosterone Replacement Therapy at Leading Endocrine Research Meeting
NORTHBROOK, IL - May 28, 2014 - Clarus Therapeutics, Inc., a men's health specialty pharmaceutical company focused on the development and commercialization of REXTORO, an oral testosterone (T) replacement product, today announced the presentation of two posters at the 16th International Congress of Endocrinology and The Endocrine Society's 96th Annual Meeting and Expo, June 21-24 in Chicago. This will be the first time in almost 20 years the two groups will unite to present ICE/ENDO 2014, with over 10,000 endocrinologists and hormone researchers from around the world expected to attend.
Ronald Swerdloff, M.D., of the L.A. Biomedical and Research Institute, Professor of Medicine at the David Geffen School of Medicine at UCLA and Chief, Division of Endocrinology at Harbor-UCLA Medical Center, will present data from two multi-center Phase 3 trials that support the efficacy and safety of REXTORO.
The following two posters will be presented during the clinical session, "Male Reproduction: Hypogonadism and Reproductive Aging," on Sunday, June 22, 2014, 1-3 p.m. CDT:
- Poster Board SUN-0088 – "Pharmacokinetics and Efficacy of a New S.E.D.D.S. Formulation of Oral Testosterone Undecanoate (TU) in Hypogonadal Men: Data from Two Phase 3 Trials with Different Dose-Titration Algorithms"
- Poster Board SUN-0089 – "Safety of a New S.E.D.D.S. Formulation of Oral Testosterone Undecanoate (TU) in Hypogonadal Men: Data from Two Phase 3 Trials with Different Dose-Titration Algorithms"
About Clarus Therapeutics
Clarus is an emerging men's specialty pharmaceutical company preparing for the commercial launch of REXTORO, an oral testosterone, or T, replacement therapy. On January 3, 2014 the Company submitted a New Drug Application, or NDA, for REXTORO to the U.S. Food and Drug Administration, or FDA. REXTORO is an oral T prodrug that, if approved by the FDA, will be used to treat men diagnosed with testosterone deficiency together with an associated medical condition, also known as hypogonadism. Clarus owns the worldwide, royalty-free commercialization rights for REXTORO. For more information, please visit: www.clarustherapeutics.com.
REXTORO is a proprietary softgel oral formulation of testosterone undecanoate for treating hypogonadal men. According to the International Journal of Clinical Practice, T deficiency affects approximately 39% of men over the age of 45. Common symptoms identified in the Endocrine Society's clinical guidelines that suggest testing for T deficiency include reduced sexual activity and desire, decreased energy, increased body fat and reduced muscle mass, depressed mood and other emotional and physiological issues. Clarus completed two Phase 3 trials of REXTORO and achieved the FDA guidance for efficacious T-replacement therapy, which is at least 75% of evaluable subjects with a serum T level in the normal range of 300 to 1,000 ng/dL, in each of the Phase 3 trials. The observed safety profile for REXTORO with the final dose titration algorithm was closely aligned with, but did not precisely meet, the FDA's targets. The most common side effects were mild GI disturbances in some subjects, a modest decrease in HDL cholesterol and modest increases in hematocrit and prostate specific antigen (PSA).