Noven Pharmaceuticals, Inc., today announced that 11 presentations, featuring data analyses from its Phase 3 pivotal trials that supported the recent U.S. Food and Drug Administration approval of Brisdelle™ (paroxetine capsules, 7.5 mg/day) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, will be showcased at the 2013 Annual Meeting of The North American Menopause Society (NAMS) in Dallas on Oct. 9-10. Brisdelle™ was specifically developed for and studied in women who experience moderate to severe VMS and is the first and only FDA-approved non-hormonal therapy clinically proven to treat moderate to severe VMS associated with menopause. Brisdelle™ will be available in pharmacies beginning November 2013.
"We are pleased to have the opportunity to share a diverse set of analyses on Brisdelle at The North American Menopause Society conference, a definitive resource for health professionals and the public for information about menopause," said Joel Lippman, M.D., FACOG, Noven's Executive Vice President – Product Development and Chief Medical Officer. "The wealth of clinical information being presented to the scientific community underscores our commitment to providing physicians with an in-depth understanding of the clinical profile of this novel non-hormonal treatment option."
The meeting and presentations will take place at the Gaylord Texan Hotel. The oral presentation will take place from 5:00 p.m. to 5:15 p.m. on Thursday, Oct. 10 in the Texas Ballroom. The ten poster presentations will take place from 6 p.m. to 7 p.m. on Thursday, Oct. 10 in the Longhorn E Exhibit Hall.
The presentations at NAMS reference Brisdelle™ as LDMP (low-dose mesylate salt of paroxetine), as it was referred to in clinical development.
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