The Food and Drug Administration (FDA) is getting the side-eye after approving a painkiller that's said to be 1,000 times stronger than morphine.
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. Approval of the drug was highly criticized; Raeford Brown, MD, chair of the FDA's Anesthetic and Analgesic Drug Products Committee, urged the FDA not to approve Dsuvia.
The medication should not be used for more than 72 hours at a time, according to the FDA.
In a November 2 statement released by the consumer group Public Citizen, the chairman of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee criticized the decision, reiterating his opposition he had previously voiced last month in a letter to FDA leaders. As part of the program, the drug maker will monitor distribution and audit wholesalers' data, evaluate proper use in the healthcare setting, and monitor for diversion or abuse and decertify any healthcare setting that is noncompliant. The pill from AcelRx Pharmaceuticals contains the same decades-old painkiller often given in IV form or injection to surgical patients and women in labor.
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.
Gottlieb said military use of the drug was "carefully considered in this case" as the FDA wants to "make sure our soldiers have access to treatments that meet the unique needs of the battlefield".
"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Sidney Wolfe, founder of Public Citizen's Health Research Group, said in a statement.
According to the FDA, Dsuvia will not be available in retail pharmacies or for outpatient use. The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical. As such, "We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", said AcelRx's CEO, Vince Angotti, in a statement.
More: Drugs kill more Americans than guns, cars and AIDS. Company executives said they expect to launch Dsuvia in the first quarter of 2019. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.
"The FDA approval of Dsuvia is the culmination of almost 15 years of research to improve the standard of care for managing acute pain in medically supervised settings", Palmer said in a statement.