Despite concerns and controversies, the U.S. Food and Drug Administration (FDA) just approved an opioid that's said to be 10 times more powerful than fentanyl.
"This new opioid will soon be hitting the market in the middle of the worst drug crisis this country has ever seen", the Bay State senator said. According to critics, the decision will only fuel the United States' drug crisis even further rather than improving it.
Gottlieb has pledged that the FDA would do more to balance efforts to curb the epidemic-which killed a record 49,000 users in 2017, according to preliminary data-with the needs of people who need strong pain relief. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths. "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.
The company producing Dsuvia, AcelRx, argued it would be an "important non-invasive, rapidly acting alternative to IV opioids".
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.
For instance, it may not be administered at home, and can only be administered by a health care provider, which means that the drug will not be available at retail pharmacies. The committee voted when its chair, Dr. Raeford Brown, who has publicly opposed the application, was not present, and FDA also failed to have the full Drug Safety and Risk Management Advisory Committee participate in the advisory committee meeting, Markey said.
"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group. The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical.
An FDA advisory committee recommended approval of the new drug in a 10-3 vote on October 12. "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". Dsuvia was a priority for the Pentagon because its unique properties make it suited for military use, which was a factor in the FDA's approval. It is expected to be available in the first quarter of next year. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.