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FWIW Reboxetine info

Posted by Omeomy on October 24, 1999, at 11:00:32

Clinical Psychiatry News
FDA Deems Antidepressant Reboxetine 'Approvable'
Elizabeth Mechcatie, Senior Writer
[Clinical Psychiatry News 27(9):8, 1999. © 1999 International Medical News Group.]


The antidepressant reboxetine is now considered "approvable" and is likely to receive full Food and Drug Administration approval by the end of the year.

In late July, the FDA issued an "approvable letter" regarding reboxetine, a selective norepinephrine reuptake inhibitor, for the treatment of depression. Reboxetine has been available in Europe for over a year.

In controlled clinical trials, 70%-80% of people with depression receiving reboxetine improved significantly, similar to the range associated with selective serotonin reuptake inhibitors (SSRIs) and tricyclics, said Dr. Christopher Gallin, vice president of clinical research-CNS at Pharmacia & Upjohn, the manufacturer of the drug.Most of the studies have been short-term, 8-week studies.

In an interview, Dr. Gallin described reboxetine as a well-tolerated, safe compound, with fewer side effects than SSRIs.

He referred to data suggesting the drug has some "potential" advantages over SSRIs in particular populations. In a study comparing reboxetine to fluoxetine in patients with depression, those patients with severe depression did significantly better with reboxetine than with fluoxetine. The potential advantage in treating severe depression is "something we're extensively exploring at this time," he said.

There are also data from a trial that used a Social Adjustment Scale, which found that reboxetine was associated with significantly better results than fluoxetine, data that are "consistent with the hypothesis that by inhibiting the norepinephrine reuptake system, we are increasing people's interest, energy, and motivation," Dr. Gallin said.

The company is launching two large trials that will rigorously test this hypothesis further.

Dr. Jack Gorman, who has not been involved in clinical trials of reboxetine but is familiar with the data, considers this drug "extremely interesting."

"Since the tricyclic era, we have not really had a pure norepinephrine reuptake inhibitor, and this is better than the tricyclics because that's all it is. It doesn't have any anticholinergic side effects," said Dr. Gorman, the Lieber professor of psychiatry and vice chair of research in the department of psychiatry, Columbia University, New York.

He also expects that it should be fairly well tolerated and should not have sexual side effects "if what we believe causes sexual side effects is true." It is thought that sexual side effects are caused by increased serotonin activity in the pathway from the midbrain raphe region down the spinal cord, he said in an interview.

Dr. Gallin said that in clinical trials, the incidence of sexual side effects are above those associated with placebo but are low and that the incidence of impotence has been 2%.

Once approved, Pharmacia & Upjohn will promote the antidepressant with Janssen Pharmaceutica under the trade name Vestra in the United States. It is marketed as Edronax and Norebox in other countries where it is approved.

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