Lundbeck and Takeda Pharmaceutical Company Limited (Takeda) today jointly announced headline results from the first three clinical trials in the phase III development programme with Lu AA21004 in major depressive disorder (MDD).
Previously reported clinical phase II data showed equal efficacy with the 5 and 10 mg doses.
In the recently completed phase III clinical trials, Lu AA21004 was tested in doses of 2.5, 5 and 10 mg. Results from two studies, which included the lower dosages, 2.5 and 5 mg, did not reach significance across studies when compared with placebo.
A third trial demonstrated mixed results, with the 2.5 mg dose not reaching statistical significance compared to placebo, and the 5 and 10 mg doses showing separation from placebo, although not in all analyses. These results also suggest that a higher dose may be more efficacious.
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 with approximately 18-24 months. Lundbeck and Takeda will continue to work with the US Food and Drug Administration (FDA) and other regulatory agencies on the clinical development program and submission plans.
Lu AA21004 is also in phase III development for generalised anxiety disorder (GAD).