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Lexapro for adolescent depression meets phase III goal

Forest Labs and Lundbeck reveal positive results from a phase III clinical trial testing Lexapro for depression in adolescents

US-based Forest Labs and Danish-headquartered Lundbeck have revealed positive results from a late-stage clinical trial testing Lexapro (escitalopram) for depression in adolescents.

The phase III study evaluated patients between the ages of 12 to 17 with major depressive disorder. Patients in the trial treated with the drug experienced "statistically significant" improvement in depression symptoms compared with a placebo, according to a press statement.

During the eight-week study, 316 patients received either 10-20 milligrams of Lexapro or placebo. The study's primary goal was for a change from baseline to the eighth week on the Children's Depression Rating Scale (Revised), an instrument that covers 17 symptom areas of depression.

Lexapro, which Forest has in-licensed from Lundbeck, is already indicated for the initial and maintenance treatment of major depressive and generalised anxiety disorders in adults.

Forest expects to file with the FDA in 2008 for approval of Lexapro in adolescents with depression and not a moment too soon. The agency has already granted final approval for Israel-headquartered generics company Teva to market three doses of generic Lexapro once the drug's patent expires in 2009.

Sales of Lexapro in the US for Lundbeck in Q3 FY07 were DKK 699m, compared with DKK 479m in the same period of FY06, an increase of 46 per cent. The increase was partly attributable to a low income level for Lexapro in 2006 due to the inventory reductions made in 2006 and partly to rising Lexapro sales on the US market.

At the end of August 2007, Lexapro maintained a 22.3 per cent hold on total antidepressants sales in the US, compared with a share of 16.9 per cent in August 2006. Measured by the total number of prescriptions, those written for Lexapro grew by 2.7 per cent in Q3 2007.

29th November 2007

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