NORTHBROOK, Ill., Sep 18, 2014 -- Clarus Therapeutics, Inc. announced today that the U.S. Food and Drug Administration's (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-3 that the overall benefit/risk profile of REXTORO™ (Testosterone Undecanoate) was not acceptable to support approval for testosterone replacement therapy. The panel also voted 12-8 with one abstention that there was not sufficient evidence that REXTORO is effective. The FDA is not required to follow the Committee's decision, but will consider its findings during the new drug application (NDA) review of REXTORO.
"We strongly believe the clinical data we presented demonstrate the safety and efficacy of REXTORO and are consistent with other testosterone replacement products that have been approved by the FDA," said Dr. Robert E. Dudley, chief executive officer, Clarus Therapeutics. "We will work closely with the FDA to respond to the panel's concerns, and remain committed to bringing REXTORO to the market as soon as possible."
In two Phase 3 trials, REXTORO met its primary endpoint of restoring testosterone to normal levels in at least 75 percent of subjects1 and demonstrated efficacy similar to currently approved treatments.1 Multiple studies have shown REXTORO has a safety profile similar to other testosterone replacement therapies.1 The most common treatment-related side effects were occasional mild GI disturbances in some subjects, a modest decrease in HDL cholesterol and side effects associated with REXTORO were increases in hematocrit, enlargement of the prostate or increases in prostate-specific antigen (PSA).1
Low testosterone, or hypogonadism, is a condition characterized by insufficient testosterone production.2 Signs and symptoms include reduced sexual activity and desire, decreased energy, increased body fat and reduced muscle mass, depressed mood and other emotional and psychological issues.2 Testosterone therapy benefits have been well-established and such therapy is the standard of care for men with diagnosed low testosterone.2
The FDA accepted Clarus Therapeutics' NDA for REXTORO on January 3, 2014 and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 3, 2014.
REXTORO is a proprietary softgel oral formulation of testosterone undecanoate1 currently under review by the U.S. Food and Drug Association as a treatment for men with low testosterone. If approved, REXTORO will offer patients and prescribing physicians a novel oral testosterone replacement option to restore testosterone levels.1
About Clarus Therapeutics
Clarus Therapeutics is a privately held men's specialty pharmaceutical company focused on the development and commercialization of REXTORO, an oral testosterone replacement therapy. Clarus Therapeutics owns the worldwide, royalty-free commercialization rights for REXTORO. The company is headquartered in Northbrook, Ill. For more information, please visit www.clarustherapeutics.com.
1 Data on file. Clarus Therapeutics. REXTORO (oral testosterone undecanoate capsules) for testosterone replacement therapy in hypogonadal men: briefing document for bone, reproductive and urologic drugs advisory committee. 2014:1-187.
2 Bhasin S, Cunningham GR, et al. Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010;95(6):2536-59.
CONTACT: Geoff Curtis Edelman 312-550-8138 [email protected]