Drugs being developed by Depomed Inc. and Hisamitsu Pharmaceutical Co. 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.
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.
Both Hisamitsu and Depomed’s drugs for hot flashes had an effect after four weeks and struggled as tests persisted out to 12 and 24 weeks, the FDA staff said in the report.
Hisamitsu’s paroxetine mesylate showed a treatment effect on hot flash frequency after 24 weeks in one study, according to the report.
Depomed’s gabapentin didn’t reduce the frequency of hot flashes after 12 weeks in any of the three studies on the drug, the report said. Two trials on gabapentin showed the drug decreased the severity of hot flashes after four and 12 weeks.
The FDA rejected Depomed’s proposed name for gabapentin, Serada, and now the company is suggesting it be dubbed Sefelsa. Gabapentin is currently used in Depomed’s Gralise, which is sold for pain associated with shingles. Gralise generated about $35 million in sales for the company last year, according to data compiled by Bloomberg.
The FDA also is reviewing an experimental drug from Pfizer Inc. and Ligand Pharmaceuticals Inc., bazedoxifene combined with a blend of estrogens. The drug would be used to treat hot flashes and vulvar and vaginal atrophy and prevent osteoporosis. The FDA is scheduled to decide by Oct. 3 whether New York-based Pfizer and Ligand, based in La Jolla, California, can market their treatment in the U.S.