FDA Approves Actonel for Broader Use in Men With Osteoporosis
CINCINNATI and BRIDGEWATER, N.J., August 14, 2006 -- On August 11, 2006, the U.S. Food and Drug Administration (FDA) approved Actonel (risedronate sodium tablets) 35 mg for treatment to increase bone mass in men with osteoporosis. FDA approval of this new indication for Actonel opens the door for more men with osteoporosis to benefit from Actonel treatment. Actonel 5 mg was approved in 2000 for use in men and women to prevent and treat certain forms of steroid-induced osteoporosis. Actonel 35 mg is also approved for the prevention and treatment of osteoporosis in postmenopausal women.
The approval of Actonel for men with osteoporosis is based on a two-year, placebo-controlled, double-blind multi-center clinical trial of 284 male patients with osteoporosis. In the trial, patients treated with once-a-week Actonel 35 mg experienced statistically significant improvements in lumbar spine bone mineral density at all time points measured, 6, 12 and 24 months. Likewise, statistically significant reductions in bone turnover markers were achieved at all time points measured, 3, 6, 12 and 24 months. Actonel was well tolerated, and adverse events were generally similar between patients receiving Actonel and patients receiving placebo. The most commonly reported adverse events were constipation, back pain, arthralgia, influenza, and nasopharyngitis.
"Male osteoporosis is a serious health concern," said Paul Miller, M.D., Director of the Colorado Center for Bone Research and Clinical Professor of Medicine at the University of Colorado Medical Center in Denver. "The approval of Actonel for men with osteoporosis provides physicians with a new treatment option."
According to the National Osteoporosis Foundation, osteoporosis affects two million men in the U.S., and another 12 million are at risk for developing the disease.
Approximately half of male osteoporosis cases are associated with aging. Men with age-related osteoporosis usually develop the disease later in life than do women. With an aging population and increasing life expectancy, age- related cases of male osteoporosis are expected to increase. The other half of all male osteoporosis cases are due to secondary causes such as oral steroid use, low testosterone (hypogonadism), and heavy alcohol use.
About Actonel (risedronate sodium tablets)
Actonel 5 mg daily and 35 mg once a week are indicated for the prevention and treatment of postmenopausal osteoporosis in women. Actonel 35 mg once a week is indicated to increase bone mass in men with osteoporosis. Actonel 5 mg daily is indicated for the prevention and treatment of glucocorticoid- induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (greater than or equal to 7.5 mg/d prednisone or equivalent) for chronic diseases.
In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.
Among patients treated with bisphosphonates, there have been infrequent reports of severe and occasionally incapacitating bone, joint and/or muscle pain. Rare occurrences of osteonecrosis, primarily of the jaw (ONJ), have been reported in patients receiving bisphosphonates. Most ONJ cases have occurred in cancer patients undergoing dental procedures. In the majority of cases reported, patients had received intravenous bisphosphonate therapy.
In clinical trials, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7% vs Actonel 5 mg 29.9%), back pain (23.6% vs 26.1%), and arthralgia (21.1% vs 23.7%).
In a 1-year clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily, the overall incidence of adverse events with the two dosing regimens was similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6% vs Actonel 5 mg 19.0%), arthralgia (14.2% vs 11.5%) and constipation (12.2% vs 12.5%).
Please see full prescribing information for Actonel (risedronate sodium tablets) for additional safety information. For a copy of the full prescribing information for Actonel visit the Actonel Web site at http://www.actonel.com.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe. It is a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.
Source: Procter & Gamble
Posted: August 2006