Ultra-Powerful Opioid Approved by FDA

  • Ultra-Powerful Opioid Approved by FDA

Ultra-Powerful Opioid Approved by FDA

Also, Dr. Palmer argues that risk for abuse is low because it must be administered-again, by a health care professional in a controlled medical center setting-under the tongue. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

"We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval - the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", Gottlieb said in his written statement. According to Gottlieb, "This opioid formulation, along with Dsuvia's unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation's soldiers on the battlefield".

Another criticism to be voiced is that Dsuvia is unnecessary: a drug that will not really add any benefit to an already saturated-and very unstable-opioid market. The drug itself is only allowed for use in health-care settings and perhaps the battlefield and is not available to be sold separately at retail pharmacies. The group noted that Dsuvia is five to 10 times more powerful than fentanyl and 1,000 times more potent than morphine. "We are committed to the safe and effective administration of Dsuvia through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program".

More: The opioid crisis hits home.

Leading the dissent was Raeford Brown, the chairman of an FDA advisory committee that reviewed AcelRx Pharmaceuticals' Dsuvia last month and ultimately recommended its approval in a 10-3 vote. It's intended for short-term use only, and should not be used for more than 72 hours.

The United States continues to struggle with the opioid abuse epidemic.

"The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain", he said. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.

As for Dsuvia, even after approval, "the FDA will continue to carefully monitor the implementation of the [regulatory safeguards] associated with Dsuvia and compliance with its requirements, and we'll work to quickly make regulatory adjustments if problems arise", Gottlieb said.

FDA Commissioner Scott Gottlieb, M.D., released a lengthy statement regarding the drug's approval, reading, in part: "the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible".

There's more on pain control at the American Society of Anesthesiologists.