Date: 2012-04-26
Type of information: Results
phase: 3
Announcement: results
Company: Pierre Fabre Medicament (France) Forrest Laboratories (USA)
Product: levomilnacipran (1S, 2R-milnacipran)
Action
mechanism: Levomilnacipran (1S, 2R-milnacipran), an enantiomer of racemic milnacipran, is protected by a method of use patent that extends through June 2023, without patent term extension. Levomilnacipran is an serotonin–norepinephrine reuptake inhibitor (SNRI) and has greater potency for norepinephrine reuptake inhibition than for serotonin reuptake inhibition in vitro without directly affecting the uptake of dopamine or other neurotransmitters. Levomilnacipran is given as a sustained-release formulation, dosed once-daily.
Disease: major depressive disorder (MDD)
Therapeutic area: CNS diseases - Mental diseases
Country:
Trial
details: This Phase III Study was a randomized, double-blind, placebo-controlled, fixed-dose study evaluating the efficacy, safety and tolerability of levomilnacipran compared with placebo in adult patients with MDD. Following a 1-week single-blind placebo run-in period, 568 men and women, 18-75 years of age, were randomized to receive either levomilnacipran 40 mg or 80 mg once daily or placebo for eight weeks. This was followed by an additional 1-week double-blind down-taper period. All patients participating in the study met the criteria for recurrent MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), and had a minimum score of 26 on the MADRS-CR. The average baseline score among participating patients was 31 on the MADRS-CR.
Latest
news: Forest Laboratories and Pierre Fabre Medicament have announced additional positive results from a Phase III clinical trial of levomilnacipran, an investigational agent for the treatment of adults with major depressive disorder (MDD).
Treatment with levomilnacipran significantly reduced depression symptoms in patients with MDD compared to placebo, as measured by the Montgomery-Asberg Depression Rating Scale - Clinician Rated (MADRS-CR). This is the third, positive Phase III study of levomilnacipran in adults with MDD. Further analyses of the data are ongoing. The companies anticipate filing a new drug application with the FDA in the third quarter of the calendar year 2012.
These study results are part of an ongoing development program for levomilnacipran, which also includes two additional Phase III studies that demonstrated statistically significant improvement over placebo. In another phase III study, levomilnacipran consistently demonstrated improvement relative to placebo over the course of the trial, however the overall difference observed between the drug-treated and placebo-treated patients was not statistically significant.
Levomilnacipran was generally well-tolerated in this study. Overall, 78.5% of patients completed the study. The premature discontinuation rates (all causes, including adverse-event related) were 17.2%, 22.9%, and 24.5% for placebo, levomilnacipran 40 mg and 80 mg groups, respectively. The most common adverse events (?10% and twice the rate of placebo) observed in the levomilnacipran groups were nausea and dry mouth.
