- Data showed that in two studies (one short-term and one long-term) of adult patients with major depressive disorder (MDD), Lu AA21004 had statistically significant separation from baseline versus placebo on the primary endpoints. In these studies, findings of the secondary outcome measures were supportive for both the 5 mg/day and 10 mg/day doses
- In two studies, none of the active treatment groups significantly differed from placebo on the primary endpoint, including the active reference duloxetine in one of these studies
- Data showed that Lu AA21004 is effective in preventing relapse in the adult patients studied with MDD
- In the four studies, the majority of adverse events (AE) were considered mild to moderate in severity across the Lu AA21004 dose groups
- Effects of higher doses (10-20 mg) than previously studied are being investigated in ongoing clinical phase III studies
- Lu AA21004 is planned to be submitted for U.S. and European registration during 2012
H. Lundbeck A/S (Lundbeck) today announced the presentation of new data from the clinical phase III programme of Lu AA21004, an investigational compound for the treatment of adult patients with major depressive disorder (MDD), at the 2011 Annual Meeting of the American Psychiatric Association (APA) in Honolulu, Hawaii. The presentations included results from four placebo-controlled clinical phase III studies as well as pre-clinical data.
“The data from the phase III studies continue to support Lu AA21004 as a multimodal anti-depressant based on its safety, efficacy as well as its relapse prevention profile,” said Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck. “With the ongoing development programme of Lu AA21004, we are building on Lundbeck’s market leadership position and our commitment to advancing medical treatment for one of the most prevalent and debilitating psychiatric disorders.”
The annual meeting of the APA is one of the largest scientific meetings for psychiatrists and other healthcare professionals involved in psychiatric research and psychiatric care.
In the U.S., Lundbeck is partnering with Takeda Global Research and Development Center Inc., U.S. on the co-development and co-commercialization of this compound. There are currently four ongoing short-term depression studies and two long-term safety studies.