Lundbeck, Takeda' Phase-III Trial Shows Mixed Results For Lu AA21004

Published: 08-Jun-2009

Appropriate dose of Lu AA21004 needs to be established

Lundbeck and Takeda jointly announced headline results from the first three clinical trials in the phase III development program with Lu AA21004, in major depressive disorder (MDD). Previously reported clinical phase II data showed equal efficacy with the 5 and 10mg doses.

Third trial demonstrated mixed results, with the 2.5mg dose not reaching statistical significance, as compared to placebo, and the 5mg and 10mg doses showing separation from placebo, although not in all analyses. These results also suggest that a higher dose may be more effective.

In all of these trials, Lu AA21004 was well tolerated and confirmed the previously observed favourable safety profile.

As a result, the most appropriate dose of Lu AA21004 needs to be established. It is anticipated that this work will postpone submission of the new drug application (NDA) in the US. Lundbeck and Takeda will continue to work with the FDA and other regulatory agencies on the clinical development program and submission plans.

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