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Lundbeck Presents Positive Results For Depressive Disorder Phase II Study

Study compared efficacy of three doses of Lu AA24530, 5mg, 10mg and 20 mg, to that of placebo

Lundbeck announces positive headline results from a dose finding clinical trial with the compound Lu AA24530. It is intended for the treatment of major depressive disorder (MDD).

The primary objective of the study was to compare the efficacy of three doses of Lu AA24530, 5mg, 10mg and 20mg to that of placebo (in terms of change from baseline on the Montgomery-Asberg Depression Rating Scale total score) after six weeks of treatment in patients with MDD. Duloxetine was included as an active reference compound in the trial.

Lu AA24530 consistently produced statistically significant improvements on the primary efficacy endpoint and on key secondary endpoints. The reference compound, duloxetine, also produced significant improvement compared to placebo, thereby validating the study. This trial also demonstrated that Lu AA24530 was well-tolerated, said the company.

Anders Gersel Pedersen, Executive Vice President and HOD for Drug Development at Lundbeck, said: “These findings demonstrate the potential value of Lu AA24530 in the treatment of major depressive disorders. We are pleased with the combination of efficacy and good tolerability for Lu AA24530 which clearly supports the development of the compound as a future treatment option for physicians and patients.”