Noven announced that the FDA has approved Brisdelle (paroxetine mesylate) capsules for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause (eg, hot flashes and night sweats).
Brisdelle, a low-dose selective serotonin reuptake inhibitor (SSRI), is the first nonhormonal therapy approved to treat VMS. Prior to Brisdelle, hormone therapy was the only approved treatment for VMS associated with menopause.
The safety and efficacy of Brisdelle were evaluated in one Phase 2 and two Phase 3 randomized, placebo-controlled studies in 1,276 postmenopausal women with VMS associated with menopause. Study results showed that Brisdelle reduced the frequency and severity of hot flashes and night sweats.
Brisdelle will be available in 7.5mg strength capsules; this is a lower dose of paroxetine than is indicated for any other condition. Brisdelle shares paroxetine warnings and precautions, including a black box warning regarding a possible increase in suicidal thoughts or actions within the first few months of treatment.
Noven is expected to launch Brisdelle capsules in November 2013.
For more information call (800) 455-8070 or visit Brisdelle.com.