FDA Approves Watson’s TRELSTAR(R) 22.5 mg, the First and Only 6-Month Intramuscular GnRH Agonist for the Palliative Treatment of Advanced Prostate Cancer
MORRISTOWN, N.J., March 11 /PRNewswire-FirstCall/ — Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced the U.S. Food and Drug Administration (FDA) approval of TRELSTARÃ‚® 22.5 mg (triptorelin pamoate for injectable suspension), a new twice-yearly formulation of TRELSTARÃ‚®, a proven, simple and effective palliative treatment of advanced prostate cancer. With an anticipated May launch, TRELSTARÃ‚® 22.5 mg is the first and only six-month intramuscular (IM) GnRH agonist available for the palliative treatment of advanced prostate cancer. TRELSTARÃ‚® 22.5 mg is also the only six-month GnRH agonist that is stored at room temperature; no refrigeration is required.
TRELSTARÃ‚® 22.5 mg releases triptorelin pamoate, a gonadotropin releasing hormone (GnRH) agonist, over a prolonged period and, in turn, suppresses testosterone production for six months. Developed by Debiopharm Group and first approved in the U.S. in 2000, TRELSTARÃ‚® is indicated for the palliative treatment of advanced prostate cancer and is currently available in one-month (3.75 mg) and three-month (11.25 mg) forms. The new, longer-acting six-month formulation is designed to provide patients and physicians with a more convenient therapeutic option that is well tolerated and as effective.
TRELSTARÃ‚® is administered via the MIXJECTÃ‚® delivery system, which utilizes a thin (21-gauge) needle, and thereby offers easy administration with low incidence of injection site pain. In fact, in the clinical trial, only 1.7% of patients reported injection site pain. Following administration, the MIXJECTÃ‚® needle is captured to help comply with OSHA regulations.
“TRELSTARÃ‚® 22.5 mg builds on our extensive and established urology portfolio, and the forthcoming May launch will mark another critical milestone in the growth of our Brand business,” said Fred Wilkinson, Executive Vice President, Global Brands at Watson. “We are confident that the unique combination of convenience, reliable testosterone and PSA suppression, and injection site tolerability of this longer-acting TRELSTARÃ‚® formulation will provide advanced prostate cancer patients and their physicians an important treatment option. In fact, we plan to further evaluate and quantify the unique injection site tolerability this product offers as compared to other commonly used GnRH agonists later this year.”
The approval is based on a 12-month (48 week) phase 3 study evaluating the efficacy, pharmacokinetics, and safety of TRELSTARÃ‚® 22.5 mg administered every six months (24 weeks) in patients with advanced prostate cancer. Over the study, TRELSTARÃ‚® 22.5 mg produced a mean testosterone serum level of 12.8 ng/dL from month two through month 12, well below castration levels associated with androgen deprivation therapy. By day 29, 97.5% of the clinical trial patients achieved castrate level, and >98% of all patients were below castrate level at month six and month 12. Median prostate specific antigen (PSA) was also reduced by 96.4% at the end of the study. The most commonly reported adverse events associated with the use of TRELSTARÃ‚® 22.5 mg included hot flushes (71.7%), erectile dysfunction (10.0%), and testicular atrophy (7.5%).
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and causes approximately 27,000 U.S. male fatalities each year. As of 2009, more than two million men in this country were estimated to be living with prostate cancer, and the National Cancer Institute estimates that nearly 200,000 men were diagnosed in the U.S. alone in 2009. The U.S. market for the palliative treatment of advanced prostate cancer is defined by the use of GnRH agonists and antagonists.
Important Safety Information
The most commonly reported adverse events associated with the use of TRELSTARÃ‚® 22.5 mg included hot flushes (71.7%), erectile dysfunction (10.0%), and testicular atrophy (7.5%). The most commonly reported adverse events associated with the use of TRELSTARÃ‚® 3.75 mg/ TRELSTARÃ‚® 11.25 mg included hot flushes (58.6%/73.0%), skeletal pain (12.1%/13.2%), impotence (7.1%/2.3%), headache (5.0%/6.9%), leg pain (2.1%/5.2%), and edema in legs (0.0%/6.3%). TRELSTARÃ‚® is contraindicated in women who are or may become pregnant as well as patients who are hypersensitive to triptorelin, other GnRH agonists, or GnRH. Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration have been reported. TRELSTARÃ‚® causes an initial transient increase in testosterone levels. Patients may experience the onset or exacerbation of symptoms during this period, including bone pain, neuropathy, hematuria, spinal cord compression, or urethral or bladder outlet obstruction. Patients with metastatic vertebral lesions and/or urinary tract obstruction should be closely observed.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., is a leading global specialty pharmaceutical company. The Company is engaged in the development 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.
In the U.S., the Watson brand portfolio includes RAPAFLOÃ‚®, GELNIQUEÃ‚®, OxytrolÃ‚®, TRELSTARÃ‚® 3.75 mg and TRELSTARÃ‚® 11.25 mg and INFeDÃ‚®. In addition, Watson markets the following brands under co-promotion agreements: AndroGelÃ‚®, with Solvay Pharmaceuticals, Inc., and FemringÃ‚®, with Warner Chilcott Limited. The Watson brand pipeline portfolio includes a number of products, including URACYSTÃ‚®, under development for cystitis; and three novel new contraceptives.
For press release and other company information, visit Watson Pharmaceuticals’ Web site at http://www.watson.com.
About Debiopharm Group
Debiopharm Group is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. The group in-licenses promising biological and small molecule drug candidates. It develops its products for global registration and maximum commercial potential. Once registered, the products are out-licensed to pharmaceutical partners for sales and marketing.
Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed four products with global combined sales of $2.6 billion in 2008.
For more information on Debiopharm Group, please visit: www.debiopharm.com
MIXJECTÃ‚® is a registered trademark of Medimop Medical Projects Ltd. All other trademarks are property of their respective owners.
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SOURCE Watson Pharmaceuticals, Inc.