Forest Laboratories and partner Pierre Fabre have presented more positive late-stage data on their investigational depression drug levomilnacipran.
The firms announced positive top-line results in a Phase III trial which showed that treatment with levomilnacipran significantly reduced depression symptoms in patients with major depressive disorder compared to placebo, as early as week one. The study involved 442 patients aged 18 to 80 years, and the drug was generally well-tolerated in this study: 77% of patients completed the trial.
This is the second, positive Phase III study in this population and results from an additional late-stage fixed-dose study are expected in the spring. However, in an earlier Phase III trial, the overall difference observed between the drug-treated and placebo-treated patients was not statistically significant, despite levomilnacipran consistently showing improvement over placebo.
Nevertheless, the two firms are pleased with the latest set of results. Marco Taglietti, R&D chief at the Forest Research Institute, noted that a New Drug Application for levomilnacipran will be filed in the USA later this year, while the head of pharmaceuticals at Pierre Fabre, Frederic Duchesne, said the data "confirm our strategy to make neuropsychiatry a major priority".
Levomilnacipran, an enantiomer of racemic milnacipran, has greater potency for norepinephrine reuptake inhibition than for serotonin reuptake inhibition in vitro without directly affecting the uptake of dopamine or other neurotransmitters, noted Forest. A sustained-release formulation, the drug is dosed once-daily.