Forest Laboratories and Pierre Fabre Medicament say that one of their three late-stage studies for the antidepressant levomilnacipran failed to hit its primary endpoint.
"Although the overall difference observed between the drug-treated and placebo-treated patients was not statistically significant," the companies reported today, "levomilnacipran consistently demonstrated improvement relative to placebo over the course of the trial."
Analysts weren't too disturbed by what they saw, though, noting that developers typically set up several shots on goal for Phase III depression programs due to the variability of responses in the field.
"The efficacy of SSRI is relatively low versus other drug classes and thus if something goes wrong in the patient pool, the primary end point could be missed. This is part of the reason companies sometimes do three pivotal trials when only two are needed," noted Aaron Gal, an analyst with Bernstein Research. "We are confident the active ingredient is active."
- here's the Forest release
- check out the Reuters story