Tag Archives: Depression

Assorted Interim Comments

1) Scott Gottlieb as FDA Commissioner: Gottlieb was Deputy Commissioner during the all-too-brief tenure of Mark McClellan, and we have followed his commentaries with interest and generally with agreement over the past decade+. We do believe that he has more … Continue reading

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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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Naurex

Over the weekend, Naurex announced that it had been acquired by Allergan (Actavis/Forest) for $560 million plus undisclosed milestones; Allergan is focused upon Naurex’s two clinical-stage Rapid-Acting-Antidepressant candidates, IV rapastinel/GlyX-13, and orally-bioavailable NRX-1074. NIR has been following this particular technology … Continue reading

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Naurex and NRX-1074

Naurex reported today that the first efficacy trial for NRX-1074, using a single-dose IV administration of a compound that will be delivered orally from now on, established a remarkable degree of immediate impact. At 24 hours post-injection of the highest … Continue reading

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The Flying Dutchman sets course for an IND

<<The Flying Dutchman is a legendary ghost ship that can never make port and is doomed to sail the oceans forever. >>  –Pedia, W. Last November, a disspiriting diaspora of neuro talent from Bristol Myers Squibb  began when BMS decided … Continue reading

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