3/1/2013 8:02:38 AM
Drugs being developed by Depomed Inc. (DEPO) and Hisamitsu Pharmaceutical Co. (4530) to ease menopausal hot flashes yielded inconsistent results in trials that call into question how meaningful the benefits would be, regulators said. Depomed’s gabapentin and Hisamitsu’s paroxetine mesylate were shown to help women avoid sudden feverish feelings linked to menopause, staff at the Food and Drug Administration said in a report today. The concern is that the reduction in severity and frequency of the flashes varied widely in clinical trials. Each drug, non-hormonal alternatives to the existing medicines, will be discussed on March 4 by agency advisers. Companies have been looking to give women more choices in menopause therapies after hormone treatments were found to increase the risk of breast cancer, heart attack and stroke. “There’s a real need for an approved product so women who don’t want to use hormones don’t have to suffer in silence,” Michael Sweeney, chief medical officer for Menlo Park, California-based Depomed, said in a telephone interview. Hot flashes affect about 32 million women in the U.S. and 40 percent choose not to use hormones or aren’t good candidates for them, Depomed said. The FDA is scheduled to decide on Depomed’s pill by May 31 and Saga, Japan-based Hisamitsu’s capsule by June 28. Suicidal Thoughts: Both drugs also carry side effects that include suicidal thoughts, which need to be considered before approval, the staff members said. The suicidal thoughts are listed as side effects in existing drugs with the same active ingredients. Hisamitsu’s paroxetine mesylate is currently sold in the antidepressant Pexeva, and Depomed’s gabapentin is used in a shingles therapy.
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