and Pierre Fabre Medicament
made an announcement
today stating that the main goal of their phase three study for levomilnacipran, a possible future treatment of major depressive disorder (MDD), had been achieved.
These recent findings are a relief for the two developmental partners as well as the medical community, especially since a previous phase three study earlier this year of levomilnacipran failed to exhibit optimistic results; the findings of that study showed that the drug decreased depression no more effectively than a placebo.
The purpose of this double-blind, randomized, placebo-controlled study was to test the drug's efficacy, safety, and tolerability.
The eight-week trial focused on 720 patients, whose depression was measured by the six-point Montgomery-Asberg Depression Rating Scale (MADRS). The researchers found that levomilnacipran decreased the depression of the participants, and further, they discovered that the participant’s scores lowered as doses increased.
MDD is estimated to affect roughly fifteen-million people in the United States each year.
"Depressed patients often struggle to find the right antidepressant and the need for new medications is high," said Dr. Marco Taglietti, Forest president and senior vice president of research and development.
The drug works through inhibiting the re-uptake of norepinephrine and serotonin, which increases the levels of these two neurotransmitters that are known to affect mood.
"These positive Phase III results are very encouraging and support the continued research of levomilnacipran in adult patients with major depressive disorder," concluded Taglietti.