Date: 2011-05-16
Type of information:
phase: 3
Announcement: results
Company: Lundbeck (Denmark)
Product: Lu AA21004
Action mechanism: Lu AA21004 is an investigational multimodal anti-depressant that is thought to work through a combination of two pharmacological modes of action: reuptake inhibition and receptor activity. It functions as a 5-HT3 and 5-HT7 receptor antagonist, 5-HT1A receptor agonist, 5-HT1B receptor partial agonist and inhibitor of the 5-HT transporter. In preclinical studies it has been demonstrated that Lu AA21004 enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain. All of the activities are considered to be of clinical relevance and potentially involved in the mechanism of action of Lu AA21004.
Disease: major depressive disorder (MDD)
Therapeutic area: Mental diseases - CNS diseases
Country:
Trial details:
Latest
news: Lundbeck has presented new data from the clinical phase III program 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.
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.
