Levomilnacipran Provides Functional Benefits in Major Depressive Disorder Patients: Presented at APA

By Liz Meszaros

PHILADELPHIA -- May 10, 2012 -- Levomilnacipran may improve symptoms and functioning in patients with major depressive disorder, according to a study presented here at the 2012 Annual Meeting of the American Psychiatric Association (APA).

“For the treatment of depression, there are many drugs available, including SSRIs [selective serotonin reuptake inhibitors] and SNRIs [selective norepinephrine reuptake inhibitors], but there are still a lot of unmet needs. Many patients still have a lot of residual symptoms,” said Anjana Bose, PhD, Forest Laboratories, Inc., New York, New York, on May 8. “Yes, there are improvements on tests, but can these patients go out to work? Can they get up in the morning on time?”

Levomilnacipran is an SSRI and SNRI, with preference for the norepinephrine transporter, and is currently under development

Researchers evaluated data from 2 fixed-dose and flexible-dose double-blind, multicentre phase 3 trials. Patients enrolled in the fixed-dose study had Montgomery-Åsberg Depression Rating Scale-Clinician Rated (MADRS-CR) scores ·30 with a current major depressive episode ·8 weeks and were randomised to levomilnacipran sustained release (SR) 40, 80, or 120 mg once daily or placebo. Patients enrolled in the flexible-dose study had MADRS-CR scores ·30 with a current major depressive episode ·4 weeks and were randomised to treatment with levomilnacipran SR 40 to 120 mg once daily or placebo.

Data from 712 patients treated with levomilnacipran SR and 358 treated with placebo were analysed. MADRS-CR scores were significantly improved in the levomilnacipran SR group compared with placebo (least-squared mean deviation [LSMD]: -2.83; P =.0006), as were Sheehan Disability Scale scores (LSMD: -1.34; P =.0301).

Significant differences in changes were also seen in the levomilnacipran SR group in the Hamilton Depression Rating Scale 17 scores (LSMD: -1.38; P =.0153), Clinical Global Impressions-Severity (CGI-S) scores (LSMD: -0.29; P =.0027), and CGI-Improvement scores ·5 (LSMD: -4.32; P <.0001).

For sites that participated in both studies, there were similar improvements on MADRS-CR total scores for patients treated with levomilnacipran SR. Placebo responses were higher in the flexible-dose study than in the fixed-dose study.

Our data show that with levomilnacipran, there are improvements functionally. Hopefully, we will be able to meet some of these unmet needs that patients currently face,ö Dr. Bose said.

Phase 3 studies on levomilnacipran are now completed, and Forest Laboratories intends to submit data to the US Food and Drug Administration by the end of this year.
Levomilnacipran provides additional benefits in terms of functional measures, in addition to improvements in normal symptoms of depression,ö Dr. Bose concluded.

Funding for this study was provided by Forest Laboratories, Inc., and Pierre Fabre MÚdicament.

[Presentation title: Levomilnacipran SR in the Treatment of Major Depressive Disorder: An Analysis of Efficacy Data From 2 Phase III Studies. Abstract NR9-33]

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