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News Release - April 28, 2009
Testosterone Undecanoate Achieves and Maintains Normal Testosterone Levels in Hypogonadal Men With Five Injections Per Year, New Data ShowLong-term Data Presented at AUA Annual Meeting
CHICAGO, April 28 (Healthcare Sales & Marketing Network) -- Endo Pharmaceuticals (Nasdaq: ENDP ) today released new long-term clinical trial data in men with hypogonadism who were treated for 21 months with testosterone undecanoate (NEBIDO(R) -- 750 mg) injection, a long-acting testosterone replacement therapy in development in the U.S. for treatment of hypogonadism. Results showed that average testosterone levels were maintained within the normal range over the 21-month study, and NEBIDO was generally well tolerated. The long-term clinical trial data were presented at the annual meeting of the American Urological Association.
Previously reported Phase III data evaluated NEBIDO's effectiveness and safety over the initial six-month treatment period in these hypogonadal men, with 94 percent of patients achieving an average testosterone level within the normal range (300-1000 ng/dL) over the 10-week treatment interval. At initiation of treatment, the average testosterone level for the patients rose into the normal range at the first sampling point, four days following the first injection. The new long-term data showed that average testosterone levels remained in the normal range throughout the 21-month study, and that NEBIDO was generally well tolerated. NEBIDO is currently under review at the U.S. Food and Drug Administration.
"Symptoms of low testosterone can be non-specific and may be dismissed as the natural consequence of aging," said Dr. Abraham Morgentaler, a leading investigator of the study and Director of Men's Health Boston, and Associate Clinical Professor of Urology at Harvard Medical School. "But treating hypogonadism can result in significant health benefits for patients."
This open-label study enrolled 130 hypogonadal men with serum testosterone levels below 300 ng/dL at study entry. NEBIDO was dosed as an intramuscular injection (750 mg) at baseline, at week four, and then every 10 weeks throughout the remainder of the 21-month study. Approximately 70 percent of patients completed all NEBIDO injections.
Evaluation of testosterone levels showed that average concentrations were consistent from one injection to the next.
Safety data showed that NEBIDO was generally well tolerated over the 21-month study, with reported side effects typically characterized as mild and non-serious. The most common side effects reported were acne (6.2 percent) and increased prostate specific antigen (5.4 percent).
Dr. Morgentaler noted: "Because men who suffer from hypogonadism need to remain on treatment for life, it is very important that they can have a treatment option that is well tolerated. Transdermal patches and gels that must be applied to the skin on a daily basis can be effective when used appropriately, but they are associated with variable patient compliance and may require extra care to prevent transfer of topical testosterone to partners or children. Long-term injections may offer hypogonadal men a convenient new option."
Hypogonadism, also known as low testosterone, is a common yet largely under-recognized and under-treated condition that affects an estimated 13.8 million men in the United States. Only 9 percent of American men with low testosterone are currently being treated with testosterone replacement therapy.
Low testosterone is associated with a broad range of physical, psychological and sexual symptoms including decreased energy and mood, fatigue, loss of muscle mass, decreased libido and erectile dysfunction. In addition, low testosterone is associated with other serious medical conditions including diabetes, cardiovascular disease and metabolic syndrome.
NEBIDO(R) is a registered trademark of Bayer Schering Pharma.
Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used to treat and manage pain, overactive bladder, prostate cancer and the early onset of puberty in children, or central precocious puberty (CPP).Its products include LIDODERM(R), a topical patch to relieve the pain of postherpetic neuralgia; PERCOCET(R) and PERCODAN(R) tablets for the relief of moderate-to-moderately severe pain; FROVA(R) tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA(R) tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA(R) ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; and Voltaren(R) Gel, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as those of the hands and the knees. Voltaren(R) Gel is owned and licensed by Novartis AG; Sanctura(R) and its XR version for treatment of overactive bladder, Vantas(R) for the palliative treatment of advanced prostate cancer, and Supprelin(R) for the treatment of early onset puberty in children. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com.
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Source: Endo Pharmaceuticals
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