Brintellix success treating sexual dysfunction in Depression patients-Lundbeck

H. Lundbeck A/S (Lundbeck) presented results about sexual functioning from a head-to-head study of Brintellix (vortioxetine) vs. escitalopram study in patients with well treated Major Depressive Disorder (MDD) experiencing treatment-emergent sexual dysfunction (TESD).

Sexual dysfunction, induced by treatment affects the patient�s quality of life and is a common reason people taking antidepressants may choose to be less compliant with their treatments and then potentially experience relapse of depressive symptoms. The results demonstrated that patients treated with Brintellix (n=169) experienced a statistically significant improvement, with a mean treatment difference of 2.2 points (95% CI: 0.48�4.02) in the CSFQ-14 total score after eight weeks of treatment (P=0.013; MMRM) compared to escitalopram (n=179). The CSFQ-14 is a recognized clinical and research instrument identifying five dimensions of sexual functioning and yields scores for three phases of the sexual response cycle. Prior to initiating the study medication, the patients were already in partial or full remission from their depression, and they maintained or slightly improved their depressive symptoms in both treatment groups after eight weeks, as measured by the Montgomery-�sberg Depression Rating Scale (MADRS) total score and the Clinical Global Impression Severity and Improvement scales (CGI � S/I). The adverse event profile for Brintellix was similar to that seen in previous trials, with nausea, headache, and dizziness being the most common side effects observed.

The FDA approved Brintellix on September 30, 2013 for the treatment of Major Depressive Disorder in adults. Brintellix is also approved since December 2013 by the European Commission for the treatment of adults with Major Depressive Episode commonly referred to as depression. More recently, the Australian Therapeutic Goods Administration (TGA) approved Brintellix for the treatment of Major Depressive Disorders in April 2014.