FDA Approved New Drug For Hot Flashes Menopause Treatment

FDA Approved New Drug For Hot Flashes Menopause Treatment

Food and Drug Administration (FDA) recently approval new drug for Hot Flashes Menopause Treatment of moderate-to-severe vasomotor symptoms linked with menopause was distinctive for at least two reasons. First, it offered the first nonhormonal option to women who cannot or do not want to use hormonal medications for Hot Flashes Menopause Treatment.
Second, the approval ran counter to the recommendation of the FDA Reproductive Health Drugs Advisory Committee, which had concluded, by a vote of 10 to 4, that the overall benefit–risk profile of Brisdelle did not support approval. The FDA always carefully believed the advice from its advisory committees but is not required to follow the committee recommendations. Why did the FDA decide, despite a negative vote from an advisory committee, to approve Brisdelle?

Vasomotor symptoms, also known as hot flushes or hot flashes, occur in as many as 75% of menopausal women in the United States. Vasomotor symptoms are not life-threatening but can greatly affect quality of life for many women, may transiently disrupt daily activities, and can impair sleep. For decades, hormonal therapy had been the only FDA-approved Hot Flashes Menopause Treatment for menopausal vasomotor symptoms, with estrogen monotherapy recommended for women who have had a hysterectomy and estrogen–progestin combination therapy prescribed for women who have not.

Hormonal therapy is highly effective for treating vasomotor symptoms, but health risks in some women became apparent about a decade ago, with the release of reports from the Women’s Health Initiative.1,2 The reports concluded, on the basis of a large randomized, controlled trial, that some risks, such as invasive breast cancer, coronary artery disease, stroke, and venous thromboembolism, were increased with the combined use of conjugated equine estrogens and progestin, whereas the risk of stroke and the risk of deep vein thrombosis were increased with the use of conjugated equine estrogens alone.

Owing to these reports, many women either have chosen not to use hormonal therapy to treat their symptoms or have not been offered such therapy because of coexisting conditions. Overall, use of hormonal therapy has decreased considerably in the past decade — a trend that underscores an unmet need for a nonhormonal treatment option for vasomotor symptoms.

Brisdelle contains 7.5 mg of paroxetine, a selective serotonin-reuptake inhibitor, and is taken at bedtime. Paroxetine For Hot Flashes Menopause Treatment is the active moiety in Paxil (paroxetine hydrochloride, GlaxoSmithKline) and Pexeva (paroxetine mesylate, Noven), which are approved for the Hot Flashes Menopause Treatment of several psychiatric conditions, including major depressive disorder. Both Paxil and Pexeva are typically taken in the morning, with doses starting at 10 to 20 mg and increased gradually, as needed, to a maximum recommended dose of 40 to 60 mg, depending on the condition being treated.

The efficacy of Brisdelle was established in two randomized, double-blind, placebo-controlled, multicenter clinical trials. Among a total of 1184 menopausal women who had a median of 10 moderate-to-severe hot flushes per day, Brisdelle was shown to provide modest relief in comparison to placebo. For example, at week 12 in one study, there was a median reduction from baseline of 5.9 moderate-to-severe hot flushes per day with Brisdelle as compared with a median reduction of 5.0 per day with placebo (median treatment difference, 0.9; P<0.01).

At week 12 in the second study, there was a median reduction from baseline of 5.6 moderate-to-severe hot flushes per day with Brisdelle as compared with a median reduction of 3.9 per day with placebo (median treatment difference, 1.7; P<0.001). Despite this modest effect, more women who used Brisdelle than women who used placebo considered the reduction in frequency of their hot flushes to be clinically meaningful. In addition, Brisdelle remained efficacious at 6 months, the latest time point assessed. This is an important finding, because a lack of efficacy at 6 months after Hot Flashes Menopause Treatment initiation would call into question its usefulness for this fairly chronic condition.this drug is very effective for Hot Flashes Menopause Treatment.