Alkermes' ALKS5461 program has the burden of its opioid legacy, which would almost certainly result in Schedule II placement, and what may be some initial euphoric/intoxicant effects.
Other depression programs of note include:
Vortioxetine, the triple amine reuptake inhibitor from Lundbeck/Takeda, in NDA-preparation, and Euthymics Bioscience with its triple amine drug, amitifadine. Forest/Pierre Fabre's levomilnacipran is having its NDA prepared. Methylation Sciences is developing a reformulation of SAMe that they believe has much better bioavailability. This could be of interest to patients and prescribers who would perceive it as less "drug," more "nutriceutical."
3) Other neurotherapeutic stories of note in the December issue include:
The successful Phase III results for Acadia Pharmaceuticals' pimavanserin.
An illuminating graphic comparison of the six-month efficacy results for EnVivo's EVP-6124 and Lilly's solanezumab.
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