Hisamitsu Pharmaceutical Co.’s Noven unit won U.S. approval for its drug to ease hot flashes associated with menopause.
The Food and Drug Administration said today it cleared the drug, to be called Brisdelle, as the first non-hormonal alternative approved to help women avoid sweating and feverish feelings linked to menopause. The active ingredient in the treatment, paroxetine, is currently sold in the U.S. by Saga, Japan-based Hisamitsu’s Noven Pharmaceuticals unit as Pexeva for depression, panic disorder and other conditions.
Hot flashes, which can cause women’s faces and upper bodies to become flushed and lead to sweating, may affect as many as 75 percent of women going through the transition that causes their menstrual periods to stop, according to the National Institutes of Health. The FDA in May rejected a non-hormonal hot flash treatment from Depomed Inc.
“There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments,” Hylton Joffe, director of the FDA’s Division of Bone, Reproductive and Urologic Products, said today in a statement announcing the approval.
Existing hormonal medications for menopause have been found to increase the risk of heart attack, breast cancer and stroke. Women who don’t want hormone therapies use depression drugs that aren’t approved to treat menopause symptoms, such as GlaxoSmithKline Plc’s Paxil, which also contains paroxetine.
Brisdelle is taken once daily at bedtime. The 7.5 milligrams of paroxetine in the drug is less than the amount in Paxil and Pexeva, the agency said. Brisdelle will carry a boxed warning about an increased suicide risk similar to Paxil and Pexeva.
The most common side effects of the drug were headache, fatigue and nausea or vomiting.
An estimated 24 million women in the U.S. are affected by hot flashes and night sweats associated with menopause and two-thirds aren’t taking any treatments for their symptoms, Joel Lippman, Noven’s executive vice president for product development and chief medical officer, said in a statement. The company said it expects Brisdelle to be available in November.
FDA staff raised concerns ahead of a February meeting of agency advisers that the drug didn’t exhibit enough of a benefit to risk side effects such as suicidal thoughts.
The agency is supposed to decide by Oct. 3 on a similar drug from Pfizer Inc. and Ligand Pharmaceuticals Inc. The medication, bazedoxifene combined with a blend of estrogens, would treat hot flashes and vulvar and vaginal atrophy and prevent osteoporosis.