Lundbeck and Takeda have jointly announced the plans for the additional clinical phase III studies on Lu AA21004 and phase III studies on Lu AA24530 in patients with major depressive disorder (MDD).
The new programme on Lu AA21004 will consist of four clinical phase III studies including approximately 2,000 patients with moderate to severe depression in addition to a long-term extension study.
The planned doses are 10mg, 15mg and 20mg. The pivotal programme is planned to commence in the first half of 2010.
Following the communication of initial top-line MDD results from previous phase III studies with Lu AA21004 in June 2009, additional data from the full programme was received and analysed.
These data showed encouraging results for the potential efficacy and the tolerability profile of Lu AA21004. Data received towards the end of 2009 from the clinical phase III programme, with 560 patients in a MDD trial, showed statistical significance on the primary efficacy endpoint across all tested doses of Lu AA21004 compared to placebo in a primarily European-based trial.
Also, encouraging results from an MDD relapse prevention study involving 639 patients showed statistically significant results on maintenance of efficacy in long-term treatment of MDD.
“With the full review of all data and dosages available we have strong data to continue development of Lu AA21004 including exploring the potential at higher dosages than previously studied”, says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck. “We are pleased that with our partner Takeda we are ready to move forward.”
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