Lundbeck And Takeda Initiate Phase III Study For Depression Drug

Takeda and H. Lundbeck A/S announced yesterday the initiation of a phase III clinical trial in Japan for Lu AA21004 in patients with major depressive disorder.

AsianScientist (May 14, 2011) – Takeda Pharmaceutical Co and H. Lundbeck A/S announced yesterday the initiation of a phase III clinical trial in Japan for Lu AA21004 in patients with major depressive disorder (MDD).

Depression is a very common, debilitating illness affecting around 121 million people worldwide, according to the World Health Organization. Depression was the leading cause of disability and the 4th leading contributor to the global burden of disease in 2000.

This randomized, double-blind and multi-center phase III clinical trial is expected to enroll approximately 360 patients with MDD and will evaluate the efficacy and safety of Lu AA21004 (5 and 10 mg) compared to placebo. The primary endpoint of this study is a change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline after eight weeks. The study is expected to be concluded in about 1½ years.

Lu AA21004 is thought to work through a combination of two pharmacological modes of action: reuptake inhibition and receptor activity. In preclinical studies it has been demonstrated that Lu AA21004 enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain.

Data from clinical trials conducted outside Japan have shown encouraging results for the potential efficacy and tolerability profile of Lu AA21004. In addition to the Japanese study, the ongoing clinical trial program includes four ongoing short-term studies and two long-term safety studies.

The strategic alliance between Lundbeck and Takeda was formed in September 2007 and will initially focus on co-development and co-commercialization of Lundbeck’s two compounds, Lu AA21004 and Lu AA24530. Once approved, the companies will co-promote the products in the United States and Japan.

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Source: Takeda.
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