Pfizer: Pristiq reduces hot flashes among postmenopausal women
WASHINGTON — A major depressive disorder treatment made by Pfizer significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women, compared with placebo, according to a new study.
The efficacy sub-study of 365 patients, conducted over a 12-week period, was part of a year-long, double-blind, placebo-controlled safety trial conducted in the United States and Canada for Pristiq (desvenlafaxine). Patients enrolled in the efficacy sub-study were required to have at least seven bothersome moderate-to-severe hot flashes per day, or 50 bothersome moderate-to-severe hot flashes per week at baseline.
Researchers found that by the fourth week, women treated with Pristiq experienced a 55% reduction in hot flash frequency (average decrease of 6.5 hot flashes per day from a baseline mean of approximately 12 hot flashes per day), compared with a 31% reduction in hot flash frequency (average decrease of 3.6 hot flashes per day from a baseline mean of approximately 12 hot flashes per day) in the placebo group.
At week 12, women in the Pristiq-treated group experienced a 62% reduction in hot flash frequency (average decrease of 7.3 hot flashes per day from a baseline mean of approximately 12 hot flashes per day), compared with a 38% reduction in hot flash frequency (average decrease of 4.5 hot flashes per day from a baseline mean of approximately 12 hot flashes per day) in the placebo group.
The data were presented at the 59th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in Washington, D.C.
Pristiq currently is under review by the Food and Drug Administration to expand its use as a treatment for moderate-to-severe vasomotor symptoms (i.e., hot flashes and night sweats) associated with menopause, Pfizer said.
“Pfizer is committed to women’s health and understands the impact that hot flashes and night sweats related to menopause can have on a woman’s life, and the importance of having options to treat menopausal symptoms,” said Steven Romano, Pfizer SVP and head of medicines development group for the primary care business unit. “If approved by the FDA for this indication, Pristiq will expand the range of effective treatment options available to help manage VMS in the United States.”
Mylan launches generic Percodan
PITTSBURGH — A generic drug maker has launched its version of a pain medication made by Endo Pharmaceuticals.
Mylan and its subsidiary Mylan Pharmaceuticals launched oxycodone and aspirin tablets USP in the 4.8355-mg/325-mg strength, based on an agreement with licensing partner Coastal Pharmaceuticals. The drug, designed to treat moderate to severe pain, is a generic version of Percodan.
Oxycodone and aspirin tablets had U.S. sales of approximately $6.5 million for the 12 months ended Dec. 31, 2010, according to IMS Health.
Currently, Mylan has 169 ANDAs pending approval from the Food and Drug Administration, the company said.
Cardinal Health’s quarterly dividend increases 10%
DUBLIN, Ohio — Healthcare services company Cardinal Health announced that its board of directors has approved an increase in the company’s quarterly dividend to 21.5 cents per share, or 86 cents per share on an annualized basis.
The declared dividend marks a 10% increase above what the company has paid out since July 2010, and also marks the 107th consecutive regular quarterly dividend for Cardinal Health.
The regular quarterly dividend is payable on July 15 to shareholders of record on July 1.