Amid deepening addiction crisis, FDA approves powerful new opioid

Desiree Burns
November 7, 2018

One stipulation of its stamp of approval was that the drug can only be administered within the walls of designated facilities like hospitals, surgical centers and emergency rooms, USA Today reported.

On Friday the Food and Drug Administration approved Dsuvia, an opioid that is 10 times more powerful than the controversial Fentanyl.

"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.

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. DSUVIA will only be distributed to health care settings certified in the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of DSUVIA", AcelRx said.

As the worst drug crisis in USA history has accelerated, agency critics and some public officials have clamored for that holistic approach to narcotic painkillers, instead of the FDA's practice of evaluating each opioid application on its own.

The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield.

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Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths.

The sublingual administration makes Dsuvia an option for patients with nothing by mouth (NPO) status and patients with hard IV access (obese, elderly, burn or needle-phobic patients), according to the statement. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. It notes that the Department of Defense was involved in its development and that it was a priority for the Pentagon because it "fills an unmet need".

Health experts said the pill isn't needed and will only worsen the opioid epidemic.

"I am very disappointed with the decision of the agency to approve Dsuvia". Writing in an October 18 letter to the FDA, Brown called the product "an extremely divertible drug", and predicted that diversion, abuse, and death would be observed within the first months of the drug's presence on the market. Alan says the concern around the drug is "valid given the potential for abuse".

"We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", AcelRx CEO Vince Angotti said in a statement. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.

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