Promise for Lundbeck and Takeda’s depression drug
pharmafile | May 20, 2013 | News story | Research and Development, Sales and Marketing | Lexapro, Lundbeck, Takeda, cymbalta, depression, lilly
Takeda and Lundbeck’s treatment for major depressive disorder has demonstrated a significant improvement in patients’ symptoms during trials.
Brintellix (Vortioxetine) which is currently under review by the FDA, showed statistically significant improvements in overall symptoms of depression against Lilly’s Cymbalta and placebo in some Phase III studies.
However, a lower-dosage study did not meet its primary endpoint for the drug seen as the successor to Lundbeck’s top-selling Lexapro, which loses patent protection early next year.
“It is important that we continue to seek new options in depression because, even though there are effective treatments available, many patients remain symptomatic,” said Madhukar Trivedi, professor of psychiatry, UT Southwestern Medical Center and advisor for both firms.
Brintellix is an investigational antidepressant with multimodal activity that is thought to work through a combination of two mechanisms of action: receptor activity modulations and reuptake inhibition.
The objective of the recent four studies was to evaluate the efficacy and safety profile of Brintellix in doses ranging from 10-20 mg per day. Three of the four pivotal studies met the primary efficacy endpoint, and statistically significant improvements in overall symptoms of depression were demonstrated.
Brintellix’s peak sales may reach as much as $3 billion, according to Deutsche Bank AG analyst Tim Race. If the drug is approved, the companies plan to co-promote it in the US and Japan.
An FDA decision on the drug is expected in October this year, following its filing there in the US in December 2012, and September for Europe.
Speaking on the trial data, Trivedi added: “As a clinician, I’m encouraged by these data. They represent an important addition to the broader clinical profile for vortioxetine and support its potential as a new treatment for patients living with MDD.”
Brett Wells
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