武田和灵北抗抑郁药Brintellix显著改善药物产生的性功能障碍

Results of a New Study of Brintellix® (vortioxetine) vs. Escitalopram on Sexual Functioning in Well Treated MDD Patients Experiencing Treatment-Emergent Sexual Dysfunction

Takeda and Lundbeck Announce Results at American Society of Clinical Psychopharmacology Annual Meeting

Hollywood, Fla. U.S.A., June 17, 2014 and Osaka, Japan, June 18, 2014 —Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) announced that the companies presented results about sexual functioning from a head-to-head study of Brintellix® (vortioxetine) vs. escitalopram in patients with well treated major depressive disorder (MDD) experiencing treatment-emergent sexual dysfunction (TESD). The data, accepted as a late-breaker, was shared in a poster presentation #41.

In the study, 447 patients with recent major depressive episodes who had responded to SSRI monotherapy but were experiencing TESD were discontinued on their initial treatment and then randomized to Brintellix 10 mg/day or escitalopram 10 mg/day (10 mg for week one and 20 mg for week two of treatment) for eight weeks. 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).

“In this study, patients who were well treated for MDD but experienced treatment-emergent sexual dysfunction showed significant improvement in sexual function with Brintellix vs. escitalopram,” said Anita H. Clayton, M.D., University of Virginia School of Medicine and study investigator. “It is helpful to have a study specifically looking at this side effect that provides more information on the topic of TESD.”

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 clinical and research instrument identifying five scales of sexual functioning and yields scores for three scales corresponding to the phases of the sexual response cycle.1 Numerically more Brintellix-treated patients were responders (change from baseline in CSFQ-14 total score > 3; OR=1.51; P=0.06), as compared with escitalopram. Numerically similar responses on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score were observed between the two groups at the end of week eight. In this study, common adverse events for Brintellix were nausea, headache, and dizziness.

These findings build on the global clinical trial program for Brintellix. The comprehensive clinical trial program evaluating the safety and efficacy of Brintellix was comprised of seven positive pivotal studies, including six 6-8 week short-term studies and one 24-64 week long-term maintenance study that demonstrated statistically significant improvements in overall symptoms of depression in adults with MDD.

The FDA approved Brintellix on September 30, 2013 for the treatment of MDD in adults.

Patients can visit www.Brintellix.com to sign up for additional information about this new treatment option.

About Brintellix (vortioxetine)
The mechanism of the antidepressant effect of Brintellix is not fully understood. It is an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action. It is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. The contribution of each of these activities to Brintellix’s antidepressant effect has not been established. It is considered to be the first and only compound with this combination of pharmacodynamic activity. The clinical relevance of this is unknown.

Brintellix was discovered by Lundbeck researchers in Copenhagen, Denmark. The clinical trial program in the U.S. was conducted jointly by Lundbeck and Takeda, and Takeda holds the new drug application for the U.S. market. Brintellix is a trademark of H. Lundbeck A/S and is used under license by Takeda Pharmaceuticals America, Inc.

The World Health Organization has issued an Anatomical Therapeutic Chemical (ATC) code for Brintellix that places it in the category of “Other” antidepressants.

The most commonly observed adverse events in MDD patients treated with Brintellix in 6-8 week placebo-controlled studies (incidence greater than or equal to 5 percent and at least twice the rate of placebo) were nausea, constipation and vomiting. Overall, 5 to 8 percent of the patients who received Brintellix 5 to 20 mg/day in short-term trials discontinued treatment due to an adverse reaction, the most common being nausea, compared with 4 percent of placebo-treated patients in these studies. Brintellix and other antidepressants may cause serious side effects. See Important Safety Information below.

In clinical studies, Brintellix had no significant effect on body weight as measured by the mean change from baseline in 6-8 week placebo-controlled studies. In the 6-month, double-blind, placebo-controlled phase of a long-term study in patients who had responded to Brintellix during the initial 12-week, open-label phase, there was no significant effect on body weight between Brintellix and placebo-treated patients. Brintellix has not been associated with any clinically significant effects on vital signs, including systolic and diastolic blood pressure and heart rate, as measured in placebo-controlled studies.

The recommended starting dose of Brintellix is 10 mg once daily without regard to meals. The dose should then be increased to 20 mg/day, as tolerated, because higher doses demonstrated better treatment effects in trials conducted in the U.S. A dose decrease down to 5 mg/day may be considered for patients who do not tolerate higher doses. The available doses provide important flexibility for physicians to help address the variability of patient needs.

Brintellix is available as 5 mg, 10 mg and 20 mg tablets.