WSJ section B-2 Better antidepressant than Prozac.
Another press release on same subject below:
Studies Show Promise for a New Antidepressant, Reboxetine, a Selective
Norepinephrine Reuptake Inhibitor
Tuesday, May 18, 1999 09:00 AM
WASHINGTON, May 18 /PRNewswire/ -- Researchers presented the results of clinical studies today
during the 152nd Annual Meeting of the American Psychiatric Association (APA) designed to evaluate
the efficacy and tolerability of reboxetine mesylate tablets, a new antidepressant under development by
Pharmacia & Upjohn (NYSE: PNU). Reboxetine, a selective norepinephrine reuptake inhibitor (NRI), is
the first in this new class of medications.
Researchers have long considered norepinephrine an important pathway in the treatment of depression
because norepinephrine depletion has been demonstrated to affect most core symptoms of
depression. Norepinephrine depletion in depressed patients is believed to be most closely associated
with several specific symptoms including lack of energy and interest and loss of motivation; addressing
these symptoms of depression is an important treatment goal for many patients.
Clinical Trial Results
The efficacy and tolerability of reboxetine was evaluated in two double-blind, parallel-group, randomized
multi-center studies of 549 patients in Europe, Latin America and Australia, diagnosed with major
depression. Both studies included an active control group treated with fluoxetine and one of the studies
was placebo-controlled. Patients received 8-10 mg./day of reboxetine (205 patients) or 20-40 mg./day
of fluoxetine (216 patients) or placebo (128 patients) for 8 weeks.
The primary outcome measure in both studies was mean reduction in Hamilton Depression Scale
(HAM-D) total scores. The HAM-D scale is a standardized instrument used by psychiatrists to
diagnose and evaluate depression. In the comparator study (non-placebo controlled), the mean
reduction in HAM-D scores was 19.2 for patients on reboxetine and 16.8 for patients on fluoxetine. In
the placebo-controlled study, the mean reduction in scores was 13.4 for reboxetine, 13.3 for fluoxetine
and 8.7 for placebo. Reboxetine was well-tolerated in both studies, with an overall adverse event rate
similar to fluoxetine: 67% for reboxetine, 65% for fluoxetine. Among the most common adverse events
reported for patients on reboxetine in both studies were dry mouth, insomnia, constipation, increased
sweating, hypotension and related symptoms, urinary hesitancy/retention, paresthesia, tachycardia
and impotence.
New Mechanism of Action
Reboxetine works by selectively inhibiting a process in the brain called "reuptake" increasing the
norepinephrine supply and its neurotransmission to various sections of the brain. Norepinephrine
deficiency is believed to be linked to the diminished energy, interest and motivation experienced by
depressed patients.
"Based on our knowledge of the role of the norepinephrine system, it has been suggested that drugs
that positively impact norepinephrine function will improve the major symptoms of depression," said
Dennis S. Charney, M.D., Deputy Chairman of Academic and Scientific Affairs, and professor of
psychiatry at the Yale University School of Medicine. "One of the ways this has been studied is to
examine the impact of lowering the availability of norepinephrine in the brain using experimental
procedures. These studies show a return of a variety of symptoms among depressed patients who had
been in remission including decreased energy, poor concentration, a return of feeling sad and loss of
interest and pleasure."
Additional Data Presented
Additional clinical study results were presented showing that reboxetine treatment led to more patients
achieving a normal Social Adaptation Self-evaluation Scale (SASS) score at last assessment than did
fluoxetine treatment (49% vs. 44%>35 points) in the two-double-blind trials with 549 patients. Social
functioning comprises active social behavior in both personal and occupational settings as well as
self-perception.
Improvements in SASS total scores from baseline to last assessment in the placebo-controlled were
10.2 (reboxetine), 7.4 (fluoxetine) and 3.3 (placebo) (p<0.05 for reboxetine vs. fluoxetine vs. placbeo).
"These studies provide important information on the role that norepinephrine plays in depression and a
possible treatment option for the many patients around the world who suffer from depression," said
study author Juan Massana, M.D., director of the Clinical Psychopharmacology Unit, Hospital Clinic,
Barcelona, Spain.
Reboxetine
Reboxetine is being developed for oral administration as a 4-mg. tablet, functionally scored for splitting
in even halves. Reboxetine is marketed outside the United States as Edronax and Norebox tablets,
and is available in the United Kingdom, Ireland, Italy, Finland, Germany, Sweden, Belgium, Denmark,
Spain and Austria.
Pharmacia & Upjohn is a global, innovation-driven pharmaceutical and health care company.
Pharmacia & Upjohn's products, services and employees demonstrate its commitment to improve
wellness and quality of life for people around the world.
SOURCE Pharmacia & Upjohn
CONTACT: Media - Gail S. Thornton, 908-306-4557, or cell phone, 973-913-5016; or Analyst - Craig
Tooman, 908-306-4450, for Pharmacia & Upjohn; or Pharmacia & Upjohn Patient Product Services
Hotline, 888-691-6813, or Pharmacia & Upjohn Physician - Pharmacist Hotline, 800-253-8600, ext.
3-8244
Quote for referenced ticker symbols: PNU
© 1999, PR Newswire |
