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Lundbeck today announced the presentation of new data on Lu AA21004, an investigational compound for the treatment of major depressive disorder (MDD), at the 165th Annual Meeting of the American Psychiatric Association (APA) in Philadelphia, USA.
The presentations included results from clinical Phase III studies as well as non-clinical data.
“The data from the phase III studies in adults further contribute to our understanding of Lu AA21004 as a multimodal antidepressant in our ongoing efforts to advance options that may address the multi-factorial symptoms faced by people with depression, ” says Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck.
He continues: “The data presented at APA support further investigation into how Lu AA21004 may address challenging symptoms of MDD such as difficulty concentrating, indecisiveness and forgetfulness.”
Summary of clinical results presented at APA
This study is a multinational, randomised, double-blind, placebo-controlled, active-reference, fixed-dose study of elderly patients with recurrent MDD assessing the efficacy and tolerability of Lu AA21004 at doses of 5 mg/day.
452 MDD patients aged 65 years or older with a current major depressive episode (MDE) of at least 4-week duration, at least one previous episode before the age of 60 years, and a Montgomery–Åsberg Depression Rating Scale (MADRS) total score of 26 or more, were randomly assigned (1:1:1) to Lu AA21004 5 mg/day, duloxetine 60mg/day (active reference), or placebo for eight weeks.
Results showed that Lu AA21004 was efficacious and well tolerated. The primary endpoint was mean change from baseline in the 24-item Hamilton Depression Rating Scale (HAM-D24) total score, a measure of the severity of MDD. According to the study results, patients taking Lu AA21004 showed a significantly (p=0.0011) greater improvement in the primary efficacy endpoint versus placebo at Week eight (mean difference to placebo of 3.3 HAM-D24 points).
HAM-D24 response (53.2% vs 35.2%) and HAM-D17 remission (29.2% vs 19.3%) rates at endpoint were higher for Lu AA21004 than for placebo. The active reference, duloxetine, also separated from placebo, demonstrating assay sensitivity.
The study also included secondary endpoints evaluating cognitive function.
These neuropsychological tests were the Digit Symbol Substitution Test (DSST), a measure of executive function, working memory, processing speed and visuo-spatial attention, and the Rey Auditory Verbal Learning Task (RAVLT), a measure of verbal learning, including recall and recognition.
Lu AA21004 showed superiority to placebo in both of these tests. Duloxetine showed superiority to placebo in the RAVLT, but not in the DSST, confirming previously published results.
Withdrawal rates due to adverse events were 5.8% (Lu AA21004) and 2.8% (placebo). Nausea was the only adverse event with a significantly higher incidence for Lu AA21004 (21.8%) versus placebo (8.3%).
For duloxetine, discontinuation due to adverse events was 9.9%, and adverse events with significantly higher incidence than that seen with placebo were: nausea (33.1%), constipation (13.9%), dry mouth (21.9%), hyperhidrosis (10.6%) and somnolence (10.6%).