FDA News

Expanded label shows Trintellix effective for SSRI-emergent sexual dysfunction

The FDA has approved a supplemental new drug application for Trintellix, which will now include labeling data from a randomized trial showing improved treatment-emergent sexual dysfunction, according to a press release.

"Sexual dysfunction is one of the most common and bothersome side effects patients with depression struggle with when prescribed an SSRI," Anita Clayton, MD, chair in the department of psychiatry & neurobehavioral sciences at University of Virginia School of Medicine, and study investigator, said in a press release. "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 an 8-week head-to-head, randomized, double-blind study, well-treated adults with major depressive disorder and treatment-emergent sexual dysfunction (n = 447) were switched from citalopram, paroxetine or sertraline to Trintellix (vortioxetine, Takeda/Lundbeck; n = 225) or escitalopram (n = 222), because of treatment-induced sexual dysfunction.

Patients in both groups received 10 mg of vortioxetine or escitalopram, which was increased to 20 mg at week 1, followed by flexible dosing at 10 mg or 20 mg. Compared with escitalopram, vortioxetine shows statistically significant improvement in mean Change in Sexual Functioning Questionnaire Short Form (CSFQ-14) total score (6.6 vs. 8.8; P = .013) from baseline to week 8. According to the overall score on a standardized depression rating scale, both drugs maintained prior improvement in depression, according to the press release.

Disclosure: Healio Psychiatry was unable to confirm any relevant financial disclosures at the time of publication.

The FDA has approved a supplemental new drug application for Trintellix, which will now include labeling data from a randomized trial showing improved treatment-emergent sexual dysfunction, according to a press release.

"Sexual dysfunction is one of the most common and bothersome side effects patients with depression struggle with when prescribed an SSRI," Anita Clayton, MD, chair in the department of psychiatry & neurobehavioral sciences at University of Virginia School of Medicine, and study investigator, said in a press release. "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 an 8-week head-to-head, randomized, double-blind study, well-treated adults with major depressive disorder and treatment-emergent sexual dysfunction (n = 447) were switched from citalopram, paroxetine or sertraline to Trintellix (vortioxetine, Takeda/Lundbeck; n = 225) or escitalopram (n = 222), because of treatment-induced sexual dysfunction.

Patients in both groups received 10 mg of vortioxetine or escitalopram, which was increased to 20 mg at week 1, followed by flexible dosing at 10 mg or 20 mg. Compared with escitalopram, vortioxetine shows statistically significant improvement in mean Change in Sexual Functioning Questionnaire Short Form (CSFQ-14) total score (6.6 vs. 8.8; P = .013) from baseline to week 8. According to the overall score on a standardized depression rating scale, both drugs maintained prior improvement in depression, according to the press release.

Disclosure: Healio Psychiatry was unable to confirm any relevant financial disclosures at the time of publication.