FDA Approves Drug For Treatment of Hot Flashes Linked With Menopause

The first non-hormonal treatment for hot flashes associated with menopause has got approval from the Food and Drug Administration.

The newly approved drug 'Brisdelle (paroxetine)' contains selective serotonin reuptake inhibitor paroxetine mesylate and is used to treat mild to severe hot flashes that are linked with menopause.

Prior to this drug 'Brisdelle', FDA had approved some treatments for hot flashes but those drugs either contain estrogen or estrogen plus a progestin.

"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," said Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research. "Today's approval provides women with the first FDA-approved, non-hormonal therapeutic option to help ease the hot flashes that are so common in menopause."

According to the FDA reports, nearly 75 percent of  women suffer from hot flashes that are linked with menopause and it can continue for up to five years or even longer. The symptoms can be embarrassing, bothersome, cause discomfort and also disrupt sleep.

The effectiveness of the drug was tested in two randomized placebo controlled studies. The study was conducted on 1,175 postmenopausal women who suffered either moderate or severe hot flashes that ranged from a minimum of 7-8 flashes per day or 50-60 per week. In one study the duration of the treatment lasted for 12 weeks and in another study the duration lasted for 24 weeks. The researchers noticed that women who were treated with Brisdelle had a drastic reduction in the frequency of hot flashes compared to the placebo group. But the investigators could not determine the mechanism by which Brisdelle decreased hot flashes.

Those treated with Brisdelle had common side effects such as headache, nausea/vomiting or fatigue. The new drug contains 7.5 mg of paroxetine and is advised to be consumed everyday at bedtime.

Other drugs that contain paroxetine are Paxila and Pexeva and they are recommended for treatment of panic disorder, anxiety disorder, obsessive compulsive disorder and major depressive disorder. Those medications that are approved to treat depression come with a boxed warning highlighting the increased risk of suicide in children and young adults.

Since the newly approved drug Brisdelle also contains similar active ingredients as Paxil and Pexeva it too comes with a boxed warning.

 Brisdelle and Pexeva are marketed by Noven Therapeutics, LLC., based in Miami, Fla.