Brintellix® demonstrated a statistically significantly superior improvement compared to escitalopram in improving sexual functioning in well treated patients suffering from depression and experiencing treatment-emergent sexual dysfunction

H. Lundbeck A/S (Lundbeck) today will present results about sexual functioning from a head-to-head study of Brintellix® (vortioxetine) vs. escitalopram in patients with well treated Major Depressive Disorder (MDD, commonly referred to as “depression”) experiencing treatment-emergent sexual dysfunction (TESD). The data, accepted as a late-breaker, will be shared in a poster presentation (#41) today at 11:15 a.m. EDT.

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-Åsberg 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.

447 patients with recent major depressive episode who had responded to SSRI monotherapy – citalopram, paroxetine and sertraline (single treatment medication) but were experiencing treatment-induced sexual dysfunction were randomized to the study. Their previous treatment was discontinued and patients were switched to flexible doses of Brintellix 10-20 mg/day or escitalopram 10-20 mg/day for eight weeks (although the dose was fixed as 10 mg for week one and 20 mg for week 2 of treatment). The dose of Brintellix or escitalopram could be adjusted after week two, four, or six, as judged by the investigator. The primary endpoint was change from baseline to week 8 in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) total score using mixed-effects model repeated measures approach (MMRM).

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.