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8/4/2004

Duloxetine Approved for Major Depression

Kate Traynor

Eli Lilly and Co. announced today that it has received approval from the Food and Drug Administration to market duloxetine hydrochloride oral capsules, or Cymbalta, for the treatment of major depressive disorder.

Duloxetine is a selective serotonin-and-norepinephrine-reuptake inhibitor and a less-potent inhibitor of dopamine reuptake.

The product's labeling (PDF) recommends that patients who use duloxetine for more than nine weeks be monitored periodically to ensure the continued effectiveness of the drug regimen. There is no information on the efficacy of the drug in adults after nine weeks of treatment or in children.

Duloxetine is contraindicated in patients with uncontrolled narrow-angle glaucoma. Concomitant use of duloxetine and a monoamine oxidase inhibitor (MAOI) is also contraindicated. According to the labeling, at least five days should lapse between stopping duloxetine and beginning MAOI therapy.

Patients who take duloxetine should be monitored for signs that their depression is worsening, including the emergence of suicidal thoughts or actions. Monitoring is particularly important whenever the dosage of duloxetine is increased or decreased.

In clinical trials, the most common adverse events reported among patients who used duloxetine were nausea, dry mouth, constipation, loss of appetite, fatigue, sleepiness, and increased sweating.

The recommended starting dosage of duloxetine is 20 or 30 mg administered twice daily or 60 mg once daily with or without meals. Dosages greater than 60 mg/day do not confer additional clinical benefits, according to the labeling.

Duloxetine will be supplied in 20-, 30-, and 60-mg capsules in unit-dose packages of 100 blister packs each. The 20-mg formulation will also be available in bottles of 60 capsules each, and the 30- and 60-mg formulations will be sold in bottles of 30, 90, or 1,000 each.

The Associated Press reported today that Lilly expects duloxetine to be available in pharmacies by the end of this month.