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

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 principle 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.

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