Tag Archives: ALKS 5461

Alkermes, ALKS5461, and the FDA

Alkermes late yesterday announced that the third of the ALKS 5461 antidepressant Phase III trials had yielded positive results for the high dose, utilizing an SPCD trial design and an alternative parsing of the MADRS as the primary endpoint. The … Continue reading

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Empty Calories: Sugar Pops and Kool-Aid

NeuroPerspective and Neurogram+ readers know that we have been less than enamored with Alkermes and its handling of the ALKS 5461 program–indeed with their R&D bent in general, which tends to be derivative and incremental. It was striking and dismaying … Continue reading

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ALKS 5461 Hits an Iceberg, The Boston Pops Plays On

Not wanting to be left out of the early-2016 chaos, the neuroscience area chimed in today with the announcement that Alkermes’ first two Phase III trials of ALKS 5461 had failed in Major Depression. In one trial (FORWARD-4), the higher … Continue reading

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