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| |  Reboxetine Effective In Treating Depression Symptoms WASHINGTON, DC -- May 18, 1999 -- Researchers presented the results of clinical studies today during the 152nd annual meeting of the American Psychiatric Association (APA) show that Pharmacia & Upjohn’s reboxetine mesylate tablets, a new antidepressant, is effective in treating the symptoms of depression. 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. The efficacy and tolerability of reboxetine was evaluated in two double-blind, parallel-group, randomised multi-centre 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 eight 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 standardised 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 percent for reboxetine, 65 percent 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. 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 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 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 percent versus 44 percent greater than 35 points) in the two-double-blind trials with 549 patients. Social functioning comprises active social behaviour 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). "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 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.
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