Lundbeck's Vortioxetine Approved In Canada For Major Depressive Disorder
By C. Rajan, contributing writer
Lundbeck has just received approval from Health Canada for Trintellix (vortioxetine hydrobromide) for the treatment of major depressive disorder (MDD). The drug will be hitting the Canadian market by the end of this year.
The Health Canada approval is based on the positive clinical trial data presented by the company in June.
Lundbeck is already marketing vortioxetine under the name Brintellix in the U.S. and EU. The drug was approved last year by the U.S. FDA and the European Commission. In April this year, the Australian Therapeutic Goods Administration (TGA) also approved vortioxetine for treating MDD.
Patrick Cashman, President and General Manager of Lundbeck Canada said, "With the approval of Trintellix by Health Canada, we strive to offer new alternatives to Canadian patients living with MDD who deserve better treatment. This is why we keep pushing boundaries, trying to improve the daily lives of people who live with mental illness."
MDD affects more than 1 in every 10 Canadian adults. The illness more often affects women than it does men, and it does not consistently respond to therapy. Patients often have to explore different treatment options to find one that works for them.
Trintellix (vortioxetine) is an inhibitor of serotonin (5-HT) reuptake and also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors, and an antagonist to a few other key receptors. Clinical trials have demonstrated that Trintellix effectively provides symptomatic relief of MDD and maintained antidepressant response for as long as 24 weeks.
This latest approval marks an eventful week for Lundbeck. The company also just presented updated results from its stroke drug, desmoteplase, indicating a brighter outcome for the drug when compared to earlier Phase 3 results.
Lundbeck last week also provided an update on the NDA status of its Carbella (carbamazepine) injection. The company reported that the FDA has sent a Complete Response Letter (CRL) requesting additional data on Chemistry, Manufacturing, and Controls (CMC) of Carbella. Lundbeck is now working to address the FDA’s requests specified in the letter, in order to meet its goal of launching Carbella by 2015, pending FDA approval.
Carbella is an investigational intravenous formulation of the well-known anti-epileptic drug (AED) carbamazepine, for use as replacement therapy in adults when oral carbamazepine administration is not feasible. Lundbeck received orphan drug designation for Carbella from FDA in 2013 and submitted the New Drug Application in March 2014.