New Long-Acting Injection in Development
WASHINGTON and CHADDS FORD, Pa., June 10 /PRNewswire/ -- About 63 percent of men who suffered from low testosterone saw two or more doctors before the condition was diagnosed, and once treated, nearly 30 percent of men said they stopped taking their medicine, according to results of a survey released today.
Results of the poll of more than 100 men who had been diagnosed with and treated for low testosterone, were released at the annual meeting of the Endocrine Society. The most frequent symptoms respondents reported were lack of energy (87 percent), decreased concentration (83 percent), loss of sex drive (82 percent) and the inability to get or maintain an erection (80 percent).
An estimated 13.9 million American men have low testosterone, also known as hypogonadism, yet only 9 percent of men are currently being treated with testosterone replacement therapy. The condition takes a significant toll on men's lives. Among men polled, 97 percent said low testosterone had a somewhat or very negative impact on the sexual aspect of their lives, and 90 percent said it adversely affected their self esteem.
"Low testosterone levels may have a marked impact on a man's sense of well being," said Raymond Rosen, Ph.D., Chief Scientist of the New England Research Institutes in Watertown, Mass. Among men polled, 61 percent said they were generally unsatisfied with their lives before being treated.
Low testosterone is associated with a broad range of physical, psychological and sexual symptoms including decreased energy and mood, fatigue, loss of muscle mass, depressed libido and erectile dysfunction. In addition, low testosterone has been associated with other serious medical conditions including diabetes, cardiovascular disease and metabolic syndrome.
"These symptoms are vague and non-specific, which may account for the apparent under-diagnosis of low testosterone," Dr. Martin M. Miner, MD , Co-Director of the Men's Health Center Miriam Hospital and Clinical, Providence, R.I. and Associate Clinical Professor of Family Medicine Warren Alpert School of Medicine of
Current treatment options include transdermal patches and gels that must be applied to the skin on a daily basis. Patients using gels must take care to prevent any transfer of testosterone to partners or children, as they have been associated with inappropriate genitalia enlargement and aggression in children. Short-acting testosterone injections are another, less popular treatment option that must be administered every two to four weeks.
"Despite the benefits of treatment, staying on therapy can be a problem for some men," Dr. Rosen said. According to the survey, 64 percent of men had used two or more testosterone replacement medicines, and 28 percent of men reported that they had stopped taking their medication at some point.
New long-acting injections that only need to be administered five times in the first year following the initial injection and every 10 weeks thereafter are in development and may offer patients a convenient new option for treatment. A majority of men polled said five shots in a year would be an improvement over their current therapies.
Although testosterone levels decline with age, hypogonadism is not a natural consequence of the aging process. "Men with clinically diagnosed hypogonadism do not need to 'tolerate' the symptoms of low testosterone," Dr. Miner said. "There may be important physical benefits to treatment, such as increased muscle mass and a reduced risk for osteoporosis. We are only beginning to explore/appreciate the link between low testosterone and more serious medical conditions such as diabetes and cardiovascular disease."
The internet survey was conducted by Forrest W. Anderson during March and April and was sponsored by Endo Pharmaceuticals Inc., which is developing the first and only long-acting injectable testosterone replacement treatment in the U.S. Testosterone undecanoate currently is pending U.S. Food and Drug Administration approval. Testosterone undecanoate was first approved in Europe in 2003 and is now marketed as Nebido in more than 80 countries by Bayer Schering Pharma AG.
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.
Endo Pharmaceuticals (Nasdaq: ENDP) 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) LA for the treatment of early onset puberty in children. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, endocrinology 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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