Noven Pharmaceuticals, Inc, a specialty pharmaceutical company, has informed that Brisdelle (paroxetine) capsules, 7.5 mg, is now available by prescription nationwide. Brisdelle is the first and only FDA-approved, non-hormonal treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly referred to as hot flashes.
The availability of Brisdelle offers women with moderate to severe hot flashes an FDA-approved, non-hormonal choice, helping to advance treatment options for menopausal women.
“The availability of Brisdelle is a major medical advancement for menopausal women dealing with moderate to severe hot flashes, which can often last five years or longer in some women,” said Lauren Streicher, MD, associate clinical professor of obstetrics and gynecology at Feinberg School of Medicine, Northwestern University. “The reality is, on average, today’s women are living over a third of their lives after the start of menopause. My hope is that this new, clinically proven option will help empower women to initiate a dialogue with their healthcare providers about finding a treatment plan that is right for them.”
Moderate to severe hot flashes – sudden feelings of intense heat in the body that include sweating – affect millions of menopausal women in the United States. Previously, hormone therapy was the only FDA-approved treatment for hot flashes associated with menopause and, because many women are unable or unwilling to take hormone therapy, symptoms were often left untreated.
“For the first time, menopausal women with moderate to severe hot flashes have access to a novel, non-hormonal medicine developed specifically for their symptoms and studied in this patient population,” said Jeffrey F Eisenberg, Noven’s president and chief executive officer. “Noven is committed to providing menopausal women with choices to address their diverse needs.”
Brisdelle is one small capsule taken once a day at bedtime. At 7.5 mg, Brisdelle contains a lower dose of paroxetine, a medicine also used to treat a number of psychiatric disorders. The lower dose of paroxetine in Brisdelle has not been studied in any psychiatric conditions and Brisdelle is not approved for any psychiatric uses.
Brisdelle (paroxetine) capsules, 7.5 mg, was approved by the FDA in June 2013 for the treatment of moderate to severe VMS associated with menopause, commonly referred to as hot flashes. 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.
Brisdelle was studied in one phase II and two phase III randomized, placebo-controlled trials in 1,276 women with moderate to severe VMS associated with menopause and was clinically proven to reduce frequency and severity of these symptoms. Brisdelle has similar warnings and precautions to the higher doses of paroxetine used to treat a number of psychiatric disorders
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products.