Additional Cariprazine Trial Could Put Forest In A Better Competitive Position
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA “complete response” letter seeks another trial to better define the most tolerable dose, which could get the atypical antipsychotic to market in a better position than the original dataset.
You may also be interested in...
Forest’s Fetzima Will Test Enantiomer Exclusivity Policy Change
The antidepressant levomilnacipran, an enantiomer of Forest’s fibromyalgia drug Savella (milnacipran), could be the first product to take advantage of an FDA Amendments Act provision that allows enantiomers of previously approved drugs to qualify for five years of new chemical entity exclusivity.
APA Update: New Antidepressants Elbow Into Crowded Market
Lundbeck/Takeda unveil pivotal trial data for Brintellix (vortioxetine) in major depression, while Forest pooled analyses shed more light on levomilnacipran in subgroups. Docs don’t think the new drugs are differentiated, but since antidepressant response is so quirky, the prescribing door is still open.
Forest Builds On Viibryd With Levomilnacipran NDA For Its “Middle” Antidepressant
Forest hopes the SNRI can follow the enantiomer blockbuster model. The application includes in vitro data showing that levomilnacipran has a greater potency for norepinephrine reuptake inhibition, without directly affecting the uptake of dopamine or other neurotransmitters.