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Brainstorm Health: FDA Opioid Approval, Daylight Saving and Hospitals, Peer Review

Brainstorm Health: FDA Opioid Approval, Daylight Saving and Hospitals, Peer Review

Brainstorm Health: FDA Opioid Approval, Daylight Saving and Hospitals, Peer Review

Brainstorm Health: FDA Opioid Approval, Daylight Saving and Hospitals, Peer Review

Brainstorm Health: FDA Opioid Approval, Daylight Saving and Hospitals, Peer Review

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FDA defends controversial opioid approval. Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a lengthy statement on Friday defending the agency’s approval of a powerful new opioid drug that’s considerably stronger than the already-powerful fentanyl, Dsuvia from AcelRx. Of note, Gottlieb points out the drug was developed in conjunction with the Department of Defense and is targeted toward a very specific segment of the population: “I believe that the unique aspects of Dsuvia, including those that make this drug a high priority for the Pentagon, differentiate this new formulation of sufentanil from other sufentanil products in a way that is consistent with population-based considerations for how it fits into the overall drug armamentarium. The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds.” (Fortune

Sage inches toward post-partum drug approval. Sage Therapeutics’ stock did a funny thing on Monday: It sank more than 8% on news that the FDA will almost certainly approve its pioneering post-partum depression drug, the first of its kind. The reason? The small sample size of clinical trials and the therapy’s risk/benefit profile could sharply limit its market potential. Case in point: The treatment’s expected approval could come with a requirement that patients have to receive extensive, monitored administration of the drug over a 72 hour period. (Fortune)

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