The U.S. Food and Drug Administration today approved Brisdelle
(paroxetine)to treat moderate to severe hot flashes (vasomotor symptoms)
associated with menopause. Brisdelle, which contains the selective
serotonin reuptake inhibitor paroxetine mesylate, is currently the only
non-hormonal treatment for hot flashes approved by the FDA.
There
are a variety of FDA-approved treatments for hot flashes, but all
contain either estrogen alone or estrogen plus a progestin.
Hot
flashes associated with menopause occur in up to 75 percent of women
and can persist for up to five years, or even longer in some women. Hot
flashes are not life-threatening, but the symptoms can be very
bothersome, causing discomfort, embarrassment and disruption of sleep.
“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.”
The
safety and effectiveness of Brisdelle were established in two
randomized, double-blind, placebo-controlled studies in a total of 1,175
postmenopausal women with moderate to severe hot flashes (a minimum of
seven to eight per day or 50-60 per week). The treatment period lasted
12 weeks in one study and 24 weeks in the other study. The results
showed that Brisdelle reduced hot flashes compared to placebo. The
mechanism by which Brisdelle reduces hot flashes is unknown.
The most common side effects in patients treated with Brisdelle were headache, fatigue, and nausea/vomiting.
Brisdelle
contains 7.5 mg of paroxetine and is dosed once daily at bedtime. Other
medications such as Paxil and Pexeva contain higher doses of paroxetine
and are approved for treating conditions such as major depressive
disorder, obsessive-compulsive disorder, panic disorder and generalized
anxiety disorder. All medications that are approved for treating
depression, including Paxil and Pexeva, have a Boxed Warning about an
increased risk of suicide in children and young adults. Because
Brisdelle contains the same active ingredient as Paxil and Pexeva, a
Boxed Warning about suicidality is included in the Brisdelle label.
Additional
labeled warnings include a possible reduction in the effectiveness of
tamoxifen if both medications are used together, an increased risk of
bleeding, and a risk of developing serotonin syndrome (signs and
symptoms can include confusion, rapid heart rate, and high blood
pressure). Brisdelle will be dispensed with a Medication Guide that
informs patients of the most important information about the medication.
The Medication Guide will be distributed to patients each time the
prescription is refilled.
Consumers and health
care professionals are encouraged to report adverse reactions from the
use of Brisdelle to the FDA MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.
Brisdelle
and Pexeva are marketed by Noven Therapeutics, LLC., based in Miami,
Fla. Paxil is marketed by GlaxoSmithKline, based in Philadelphia, Pa.
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