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Noven Pharmaceuticals, Inc., has received the US Food and Drug Administration (FDA) approval for brisdelle low-dose paroxetine capsules, 7.5 mg/day, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly referred to as hot flashes and night sweats.
Prior to the approval of brisdelle, hormone therapy was the only FDA-approved treatment for VMS. Many women are unable or unwilling to take hormone therapy to treat their VMS associated with menopause, often leaving symptoms untreated.
“Noven is proud to have developed brisdelle, the first and only FDA-approved nonhormonal option for the treatment of moderate to severe VMS, and to be the first company to offer both nonhormonal and hormonal treatment options for women with VMS,” said Jeffrey F Eisenberg, Noven’s president and chief executive officer. “We will commercialize brisdelle in the US through our Noven Therapeutics Women’s Health division and we estimate that brisdelle will be available in US pharmacies in November 2013.”
At the unique low dose of 7.5 mg of paroxetine as a mesylate salt, brisdelle was specifically developed for and studied in women who experience hot flashes and night sweats associated with menopause. brisdelle contains a lower dose of paroxetine than is indicated for any other condition.
“The FDA approval of brisdelle addresses the unmet need for a clinically proven nonhormonal treatment option for hot flashes and night sweats,” said David Portman, MD, director of the Columbus Centre for Women’s Health Research and brisdelle clinical trial investigator. “As a clinician, the comprehensive prescribing information and proven data for brisdelle enable me to confidently offer women with moderate to severe VMS a nonhormonal option that is safe and effective.”
brisdelle was clinically proven to reduce the frequency and severity of hot flashes and night sweats. brisdelle was studied in one phase II and two phase III randomized, placebo-controlled trials in 1,276 women with VMS associated with menopause. The most common adverse reactions, defined as those experienced by at least two per cent of patients taking brisdelle compared to placebo were headache (6.3 vs. 4.8 per cent), fatigue/malaise/lethargy (4.9 vs. 2.8 per cent) and nausea/vomiting (4.3 vs. 2.3 per cent). Of these commonly reported adverse reactions, nausea occurred primarily within the first four weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in frequency with continued therapy. brisdelle shares paroxetine warnings and precautions.
“The approval of brisdelle is significant because it meaningfully expands the therapeutic options for the 24 million women in the US affected by moderate to severe VMS, two-thirds of whom are not currently treating these often debilitating symptoms,” said Joel Lippman, MD, FACOG, Noven’s executive vice president – Product Development and chief medical officer. “Noven has long focused on developing and offering therapies to address women’s menopausal health concerns, and we are pleased to address the diverse needs of this population.”
In clinical development, brisdelle was referred to as low-dose mesylate salt of paroxetine (LDMP) and Mesafem.
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