FDA Approves Watson’s AndrodermÂ® (testosterone transdermal system) 2 mg/day and 4 mg/day
PARSIPPANY, N.J., Oct. 21, 2011 /PRNewswire/ — Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that the U.S. Food and Drug Administration (FDA) approved its AndrodermÃ‚® (testosterone transdermal system) 2 mg and 4 mg formulation. The new smaller size and lower-dose testosterone patch provides highly effective testosterone administration with a 20 percent reduction in the active ingredient from the original strength in a smaller patch size. Watson plans to launch the new AndrodermÃ‚® formulation in November 2011 and the product will be marketed in the U.S. by the Company’s Global Brands business.
Approval of the lower dose formulation was based on a trial showing 97 percent of the subjects achieved testosterone concentrations within the normal range after 28 days of daily therapy. In the study, 94 percent of patients achieved normal testosterone levels by Day 8 with the 4 mg/day formulation with low rates of many common testosterone-related adverse events. The recommended starting dose for the new AndrodermÃ‚® transdermal system is 4 mg/day, which may be increased to 6 mg/day or decreased to 2 mg/day as needed.
AndrodermÃ‚® is indicated as testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Low testosterone affects an estimated 13.8 million men in the United States; its prevalence increases with age. Causes for testosterone deficiency include genetic abnormalities, side effects from certain medications, pre-existing conditions such as diabetes, and injury to the testes.
“The approval of the new low-dose testosterone patch offers millions of men a reliable and convenient transdermal option for what continues to be an under-diagnosed and undertreated condition,” said Jed C. Kaminetsky, MD, urologist at University Urology Associates and clinical assistant professor of urology at New York University School of Medicine. “The new AndrodermÃ‚® formulation effectively treats symptoms of male hypogonadism, which include decreased sexual desire, fatigue and mood depression. In addition, the patch helps minimize the risk that the testosterone may be transferred from patients to children or women, unlike testosterone gel preparations.”
Testosterone is one of two naturally-produced male hormones, endogenous androgens, responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Symptoms of male hypogonadism include erectile dysfunction, decreased sexual desire, fatigue, loss of energy, mood depression, regression of secondary sexual characteristics, and osteoporosis.
About AndrodermÃ‚® (testosterone transdermal system)
AndrodermÃ‚® is a convenient, once daily skin patch, called a transdermal delivery system. The patch delivers consistent, controlled concentrations of testosterone through the skin and is proven to be effective. In clinical studies, AndrodermÃ‚® helped most men achieve normal testosterone levels into their bloodstream. AndrodermÃ‚® is applied to the back, abdomen, thighs, or upper arms.
In previous studies with Androderm strengths of 2.5 mg/day and 5 mg/day, AndrodermÃ‚® significantly improved sexual function, energy, and mood in men with low testosterone levels. The patch delivers consistent testosterone throughout the 24-hour day. The potential benefit of sustained delivery means there may be fewer risks for ups and downs in mood, energy, or sexual desire. While the clinical significance is not known, the patch also simulates the circadian rhythm of testosterone observed in healthy young men. In clinical studies, AndrodermÃ‚® had no significant effect on prostate size, or on PSA levels (prostate specific antigen). Also, AndrodermÃ‚® causes manageable side effects at the application site and minimal risk of transference from patients to children or women.
Important Safety Information
Androderm should not be used in men with carcinoma of the breast, known or suspected carcinoma of the prostate, or patients with pre-existing cardiac, renal or hepatic disease. Androderm should also not be used in pregnant or breastfeeding women, as testosterone may cause fetal harm. Patients with benign prostatic hyperplasia (BPH) should be monitored for worsening signs and symptoms, and exposure of Androderm to women or children should be avoided. Exogenous administration of testosterone may lead to azoospermia, and sleep apnea may occur in those with risk factors. Patients should be monitored for prostate specific antigen (PSA), liver function, lipid concentrations, hematocrit and hemoglobin. In a clinical study of 36 patients treated with AndrodermÃ‚®, skin irritation from the patch was the most common adverse event (pruritus at application site (17 percent)), followed by application site vesicles (6 percent) and back pain (6 percent).
About Watson Pharmaceuticals
Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women’s Health. Watson has operations in many of the world’s established and growing international markets.
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Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson’s current perspective of existing information as of the date of this release. It is important to note that Watson’s goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson’s current expectations depending upon a number of factors, risks and uncertainties affecting Watson’s business. These factors include, among others, the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers’ facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson’s periodic public filings with the Securities and Exchange Commission, including but not limited to Watson’s quarterly report on form 10-Q for the quarter ended June 30, 2011 and Watson’s annual report on Form 10-K for the year ended December 31, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
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SOURCE Watson Pharmaceuticals, Inc.