Additional Cariprazine Trial Could Put Forest In A Better Competitive Position
This article was originally published in The Pink Sheet Daily
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.
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Gedeon Richter has finally had its antipsychotic cariprazine approved in the EU for treating schizophrenia - but its delay to market could dampen demand for the drug unless it can differentiate itself from rivals.
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.
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.