Health Care

FDA OKs Powerful New Opioid Dsuvia Despite Criticisms

FDA OKs Powerful New Opioid Dsuvia Despite Criticisms”

In a statement, FDA Commissioner Scott Gottlieb, MD, sought to deflect criticism of the approval, saying that, "Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that's available to patients and providers".

The Food and Drug Administration (FDA) is taking heat for approving a powerful, fast-acting opioid.

But critics of the drug and its potency - it's 10 times stronger than fentanyl - are tired that such a pill could add to the country's already alarming opioid epidemic.

The painkiller Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, but critics worry the opioid will fuel an already grim opioid epidemic.

"To that end, I've asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals", he said. "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.

Sidney Wolfe of Public Citizen's Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency missed a big opportunity when it approved the pill.

More: The opioid crisis hits home. Gottlieb noted Dsuvia was "a priority medical product for the Pentagon" and the military's use "was carefully considered in this case". It's an alternative to IV painkillers used in hospitals.

More: Drugs kill more Americans than guns, cars and AIDS.

Drug overdose deaths hit the highest level ever recorded in the United States previous year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo.

Although the FDA is committed to reducing the opioid crisis and despite their claims to work in the interest of addiction-free drugs, the latest opioid may go against everything that has been said. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. Company executives said they expect to launch Dsuvia in the first quarter of 2019.

Supporters of the drug also argue that even though sufentanil is known to be very potent, the effective dose of Dsuvia is a tiny, premeasured 30 mcg. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.



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