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Rextoro

Treatment for Hypogonadism -- Male

NDA Submitted for Rextoro

Clarus Therapeutics Submits New Drug Application for Rextoro (formerly CLR-610) for the treatment of Low Testosterone

NORTHBROOK, Ill – January 13, 2014 -- Clarus Therapeutics, Inc., today announced the submission of a New Drug Application (NDA) for Rextoro™ (formerly CLR-610), the Company’s oral testosterone (T) replacement product, to the U.S. Food and Drug Administration (FDA). Efficacy consistent with the current FDA mandate for T-replacement products was achieved in two Phase 3 studies. After protocol-prescribed dose titration, at least 75% of men treated with Rextoro achieved average serum T levels (C-avg) in the normal range (between 300 – 1,000 ng/dL).

“If approved, we believe Rextoro will be an appealing option for men and their healthcare providers over the currently available transdermal or injectable products,” said Theodore M. Danoff, M.D., Ph.D., Clarus’ VP of clinical development and chief medical officer. “An oral T-replacement product would not only be convenient, but would avoid many of the safety issues associated with accidental transfer of testosterone to women or children that can occur from transdermal products. We look forward to working with the FDA to advance Rextoro to market.”

Ronald S. Swerdloff, M.D. who served as principal investigator for the Phase 3 trials of Rextoro at the LA Biomedical Research Institute and is professor of medicine at UCLA’s David Geffen School of Medicine and chief of the Division of Endocrinology, Harbor-UCLA Medical Center stated, “The addition of a new oral testosterone treatment option for men with low T is an important advance -- one that hypogonadal men and their physicians have wanted for a long time. Pending FDA approval, Rextoro will be attractive to many of my patients with low T.”

The observed safety profile for Rextoro with the final dose titration algorithm reflected the well-recognized pharmacological effects of T-replacement therapy and is consistent with the profiles of approved T-replacement products. 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).

About Clarus Therapeutics

Clarus is a privately held biopharmaceutical company focused on the development and commercialization of our oral T-replacement product, Rextoro (formerly CLR-610). According to the American Urological Association, 10% of men 40-to-60 years of age, and 20% over the age of 60 have low T levels. Common symptoms associated with low T may include mild depression, increased body fat, decreased energy, reductions in lean body mass, muscle strength and bone mineral density, low sex drive and erectile function. For more information, please visit: www.clarustherapeutics.com.

Source: Clarus Therapeutics

Posted: January 2014

Rextoro (testosterone undecanoate) FDA Approval History

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