Lundbeck has rolled out a fresh set of positive data on its new antidepressant Brintellix (vortioxetine/Lu AA21004), this time offering up some head-to-head results to help position the drug in the marketplace.
The pharma company, which has been scrambling to find a new franchise drug that could help replace Lexapro, already has a battery of late-stage data on Brintellix. This time around investigators decided to compare it with agomelatine, which Servier sells in Europe as Valdoxan but never made it onto the U.S. market. Novartis ($NVS) had taken control of U.S. rights, but never pursued an approval.
According to investigators, patients taking Brintellix did significantly better on a system for rating depression. The Lundbeck drug groups also did better on secondary endpoints related to anxiety and overall functioning. The patients had all failed to respond to a depression drug, a common experience in this field, where hit-and-miss therapeutic strategies have been standard for years.
"Patients with inadequate response to current SSRI or SNRI therapies represent a large proportion of patients suffering from major depression. Only a few years ago, the landmark STAR*D study confirmed a significant unmet medical need as only half of patients responded to their first-line treatment, which was an SSRI. First-line treatments in clinical practice are typically SSRIs or SNRIs," says EVP Anders Gersel Pedersen, the head of R&D at Lundbeck.
Lundbeck has been building up a big store of late-stage data on this drug. The company reported last spring that "out of the ten large, placebo-controlled studies of Lu AA21004 completed in patients with MDD, eight have shown effect of Lu AA21004." The FDA accepted an NDA from Lundbeck and its partner Takeda on Brintellix last December.
- here's the press release