Hormone replacement therapy (HRT) can relieve distressing menopausal symptoms such as hot flashes (vasomotor symptoms). However, some women have medical conditions (e.g., estrogen receptor positive breast cancer) that prohibit their use. In addition, some women are fearful of their use because of their association with breast or endometrial cancer. In June 2013, Brisdelle™ (paroxetine capsules) was approved by the United States Food and Drug Administration (FDA) for the treatment of moderate to severe hot flashes. On September 18, Noven Pharmaceuticals, Inc. announced that Menopause, the peer-reviewed, scientific journal of The North American Menopause Society, published the results of two promising Phase 3 clinical studies on the first and only non-hormonal treatment for moderate to severe vasomotor symptoms associated with menopause.
Noven notes that the publication of these data is timely and important because approximately 24 million women in the US are affected by moderate to severe hot flashes and night sweats; however, Brisdelle was specifically developed for and studied in women who experience moderate to severe vasomotor symptoms and is the first and only FDA-approved non-hormonal therapy clinically proven to treat moderate to severe vasomotor symptoms. Brisdelle will be available in pharmacies beginning November 2013. “Prior to the approval of Brisdelle, physicians did not have a clinically proven and FDA-approved, non-hormonal treatment option to offer women,” said Joel Lippman, M.D., FACOG, Noven’s Executive Vice President – Product Development and Chief Medical Officer.
Menopause published the 12-week and the 24-week multicenter, double-blind, randomized, placebo-controlled Phase 3 clinical studies evaluating Brisdelle for the treatment of moderate to severe vasomotor symptoms associated with menopause. The co-primary endpoints of the studies evaluated weekly reductions in the frequency and severity of hot flashes associated with menopause in patients taking Brisdelle versus placebo at Week 4 and Week 12. Persistence of treatment benefit was also evaluated at 24 weeks in the 24-week study.
Brisdelle was studied in one Phase 2 and two Phase 3 randomized, placebo-controlled trials in 1,276 women with moderate to severe hot flashes associated with menopause and clinically proven to reduce the frequency and severity of hot flashes and night sweats. The most common adverse reactions, defined as those experienced by at least 2% of patients taking Brisdelle compared to placebo were headache (6.3% vs. 4.8%), fatigue/malaise/lethargy (4.9% vs. 2.8%) and nausea/vomiting (4.3% vs. 2.3%). Brisdelle has similar warnings and precautions to the higher doses of paroxetine used to treat a number of psychiatric disorders, including a Boxed Warning about Suicidal Thoughts or Behaviors. The lower dose of paroxetine in Brisdelle™ has not been studied in any psychiatric conditions and Brisdelle is not approved for any psychiatric uses.
In the 12-week study, average weekly reductions in vasomotor symptoms frequency were significantly greater for Brisdelle than for placebo at Week 4 (–33.0 and –23.5, respectively) and at Week 12 (–43.5 and –37.3, respectively). In the 24-week study, average weekly reductions in VMS frequency were significantly greater for Brisdelle than for placebo at Week 4 (–28.9 and –19.0, respectively) and at Week 12 (–37.2 and –27.6, respectively).
In the 12-week study, average weekly reductions in VMS severity from baseline were significantly greater for Brisdelle than for placebo at Week 4 (–0.09 and –0.05, respectively) but not at Week 12 (–0.10 and –0.09, respectively). In the 24-week study, average weekly reductions in VMS severity were significantly greater for Brisdelle than for placebo at Week 4 (–0.09 and –0.06, respectively) and at Week 12 (–0.12 and –0.07, respectively).
A Brisdelle comes with an important safety warning that notes a woman taking the medication should call her healthcare provider right away or present at a hospital emergency department if she experiences any of the following symptoms:
- Brisdelle and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment.
- Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
- Watch for these changes and call your healthcare provider right away if you notice: new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe; pay particular attention to such changes when Brisdelle is started; Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.