INVESTIGATIONAL OC RELIEVES SYMPTOMS OF PMS
An investigational oral contraceptive that releases steady amounts
of estrogen and drospirenone, a novel progestin, relieves premenstrual
symptoms.
PHARMACIA MIGRAINE DRUG WINS FDA APPROVAL
The US Food and Drug Administration has approved Pharmacia Corp.'s
Axert (almotriptan malate) tablets for acute treatment of migraine
with or without aura in adults.
Investigational OC Relieves
Symptoms of PMS
CHICAGO (Reuters Health) May 04 - An investigational oral contraceptive
that releases steady amounts of estrogen and drospirenone, a novel
progestin, relieves premenstrual symptoms, according to study results
presented here at the 50th annual meeting of the American College
of Obstetricians and Gynecologists.
Dr. Candace Brown, a professor of pharmacology, psychiatry and
obstetrics/gynecology at the University of Tennessee in Memphis,
said that the drug has diuretic and antiandrogenic effects. On average,
the 258 women who took it for 6 cycles had a marked reduction in
negative affect and water retention by the end of the multicenter
study.
These were "normal, healthy women," Dr. Brown told Reuters
Health. "In women with more severe premenstrual symptoms or
with premenstrual dysphoric disorder, I expect the results will
be greater," she said.
Dr. Brown said that the new drug, which will be marketed under
the name Yasmin, is awaiting marketing clearance by the US Food
and Drug Administration. The manufacturer, Berlex Laboratories,
expects approval sometime this summer. After it is approved as a
contraceptive, the company plans to ask the FDA to approve its use
for treatment of premenstrual symptoms, Dr. Brown said.
She added that the study was open-label, "so we will need
to wait for results of a well-planned, placebo-controlled trial
to verify the findings."
Dr. Brown hopes that Yasmin will relieve premenstrual dysphoric
disorder-related affective disorders in a forthcoming 21-center
placebo-controlled trial. "We've decided to bypass PMS and
go all the way to PMDD, and we are very hopeful that this pill will
demonstrate a benefit for this disorder," she says.
Dr. Brown said she has found that women "are willing to take
a birth control pill than they are to take an antidepressant. There
is still a stigma surrounding the use of antidepressants."
Pharmacia Migraine Drug Wins
FDA Approval
NEW YORK (Reuters Health) May 08 - The US Food and Drug Administration
has approved Pharmacia Corp.'s Axert (almotriptan malate) tablets
for acute treatment of migraine with or without aura in adults.
According to Peapack, New Jersey-based Pharmacia, in clinical studies,
the percentage of patients who achieved a response of mild or no
pain 2 hours after treatment was significantly greater among the
patients who received Axert than among those who received placebo.
The company said that the incidence of side effects with Axert was
low and similar to the incidence with placebo.
The most common side effects reported in the studies were nausea,
dry mouth and paresthesia. Pharmacia said that Axert should not
be given to patients with documented ischemic or vasospastic coronary
artery disease.
Dr. Egilius L. H. Spierings, associate clinical professor of neurology
at Harvard Medical School and principal investigator of the study,
said, "The solid performance of Axert, with its strong efficacy
plus its favorable side effect profile, will make it a new treatment
option for physicians and patients."
Dr. Spierings, who is also general medical director of the Boston
Clinical Research Center, on Tuesday released data from a head-to-head
study comparing Axert with GlaxoSmithKline's Imitrex (sumatriptan).
In a double-blind study, patients who received Axert 12.5 mg for
moderate or severe migraine headache demonstrated similar pain relief
at 2 hours to patients who received Imitrex 50 mg.
Patients who received Axert reported "significantly fewer
side effects," particularly less chest pain, compared with
patients who received Imitrex, according to the research center.
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