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Lundbeck today announced positive headline results from a dose finding clinical trial with the compound Lu AA24530 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, 5, 10 and 20 mg, to that of placebo in terms of change from baseline on the Montgomery- Åsberg Depression Rating Scale (MADRS) 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 active reference compound, duloxetine, also produced significant improvement compared to placebo, thereby validating the study. This trial also demonstrated that Lu AA24530 was well-tolerated. Drop-out rates due to serious adverse events were low in groups treated with Lu AA24530 and were similar to those of duloxetine.
“These findings demonstrate the potential value of Lu AA24530 in the treatment of major depressive disorders”, says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck. “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.”