Wyeth Pharmaceuticals, a division of Wyeth, reported that new study data presented at the 63rd Annual Meeting of the American Society for Reproductive Medicine (ASRM) showed that women who received 100 mg/day or 150 mg/day of desvenlafaxine, a serotonin and norepinephrine reuptake inhibitor (SNRI), experienced a significant reduction in moderate to severe vasomotor symptoms (VMS) (hot flashes and night sweats) associated with menopause over those taking placebo. This significant reduction was seen as early as week one.
The common adverse drug reactions (greater than or equal to five percent of either desvenlafaxine group) in this study were asthenia, hypertension, anorexia (loss of appetite), constipation, diarrhoea, dry mouth, nausea, dizziness, insomnia, somnolence and mydriasis.
"There are more than 10 million menopausal women who experience moderate to severe hot flashes and night sweats. Only a small percentage of menopausal women use FDA-approved treatments, all of which are hormone-based. Wyeth is committed to continuing to develop desvenlafaxine as a potential non-hormonal treatment option for women with moderate to severe vasomotor symptoms associated with menopause," said, Ginger Constantine, M.D., vice president, Women's Health Care, Wyeth Pharmaceuticals.
In July 2007, Wyeth received an approvable letter from the FDA for desvenlafaxine in the treatment of moderate to severe vasomotor symptoms associated with menopause. Wyeth is working with the FDA to address several items in the letter and to gain agreement on the design of one additional safety study. The efficacy and safety data for desvenlafaxine presented at the meeting represents only a portion of the totality of data that the company has submitted to the FDA, the company statement said.
"Additional treatment options are important for the millions of U.S. women experiencing hot flashes and night sweats associated with menopause. Vasomotor symptoms can be quite disruptive for women in performing their daily activities. The study findings presented show that desvenlafaxine significantly reduced the number of hot flashes in postmenopausal women, and thus, if approved, may be an important treatment option," said, David F. Archer, lead investigator of the 12-week study and professor, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Clinical Research Centre, Norfolk, Virginia.
Postmenopausal women (N=458) with 50 or more moderate to severe hot flashes per week received either desvenlafaxine 100 mg/day, 150 mg/day or placebo. In addition, also presented was a secondary analysis of a previously presented 52-week study with desvenlafaxine.
The analysis of the 12-week trial showed that desvenlafaxine 100 mg significantly reduced the frequency of moderate to severe hot flashes by
65 per cent from baseline to the end of the trial, compared to a 51 per cent reduction for placebo. This reduction in frequency of hot flashes with desvenlafaxine 100 mg was seen beginning at week one. The severity of hot flashes also reduced significantly at all time points compared to placebo among postmenopausal women who received desvenlafaxine.
Results from the secondary analysis of the 12-week study showed that desvenlafaxine 100 mg or 150 mg improved total mood disturbance score as measured by the Profile of Mood States (POMS), and climacteric symptoms as measured by the Greene Climacteric Scale (GCS), in postmenopausal women with moderate to severe vasomotor symptoms. Mood and climacteric symptoms were assessed by POMS and GCS, respectively, at baseline and weeks 4 and 12.
Wyeth Pharmaceuticals is committed to improving the care of patients and understanding the clinical and safety information about its products. The clinical development program for desvenlafaxine involves thousands of subjects and represents a continued exploration of the molecule's potential utility in multiple conditions.
Antidepressants, including SSRIs and SNRIs, increased the risk compared to placebo of suicidal thinking and behaviour (suicidality) in children, adolescents and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behaviour. Families and caregivers should be advised of the need for close observation and communication with the prescriber, the company said.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of womenâ health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, haemophilia, oncology, vaccines and nutritional products.