A supplemental new drug application (sNDA) for vortioxetine (TRINTELLIX), a prescription medication for the treatment of adults with major depressive disorder (MDD), has been accepted by the FDA.
A supplemental new drug application (sNDA) for vortioxetine (TRINTELLIX), a prescription medication for the treatment of adults with major depressive disorder (MDD), has been accepted by the US Food and Drug Administration (FDA).
With the sNDA, prescribing information for vortioxetine now includes data that demonstrates vortioxetine’s superiority to a commonly used selective serotonin reuptake inhibitor (SSRI), escitalopram (Lexapro), in improving treatment-emergent sexual dysfunction (TESD).
"Sexual dysfunction is one of the most common and bothersome side effects patients with depression struggle with when prescribed an SSRI," lead study investigator, Anita Clayton, MD, chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine, said in a recent statement. "We designed the study to specifically look at these troublesome side effects. Changing to a medication with potentially fewer sexual side effects, while not losing progress in treating depression, provides an important option for patients with depression."
In the 8-week head-to-head, randomized, double-blind clinical trial that served as the basis for sNDA, patients with MDD with TESD (N=447) who were well treated switched from citalopram, paroxetine, or sertraline to either vortioxetine (N=225) or escitalopram (N=222).
Patients were started on 10 mg for either vortioxetine or escitalopram and increased to 20 mg at week 1; flexible dosing (10 mg or 20 mg) followed.
From baseline to week 8 as measured by mean Change in Sexual Functioning Questionnaire Short Form (CSFQ-14) Total Score (8.8 vs. 6.6, p=0.013), a statistically significant improvement compared to escitalopram was demonstrated. Based on overall score on standardized depression rating scale, both drugs maintained prior improvement in depression.
This indication serves as the first time an antidepressant has included data of this type in its labeling.
Previously, vortioxetine was been granted another label update pertaining to improvements in processing speed as well.