Officials with the FDA have approved a new opioid, (Dsuvia, AcelRx Pharmaceuticals), sparking some controversy in the media that the opioid has potential for abuse.
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 drug is supplied in a 30 microgram tablet in a single-dose, prefilled applicator for administration by a healthcare professional, and it will not be available in retail pharmacies or for outpatient use. Acknowledging the criticism, he said he's asked FDA staff to "evaluate a new framework" for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks. The goal, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide.
Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis.
"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.
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 also points out in his statement that it can help in special circumstances in which a patient may not be able to swallow, adding that there could be potential uses on the battlefield.
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Additionally, four Democratic senators had urged Gottlieb to deny approval on Dsuvia until Brown and other drug safety committee members could participate in the decision and vote, in a letter they sent last Wednesday.
The drug is also only for use by patients who can not tolerate other painkillers, or for whom other painkillers have failed or are expected to fail.
Drug overdose deaths hit the highest level ever recorded in the United States a year ago, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.
"I am very disappointed with the decision of the agency to approve Dsuvia". AcelRx returned to the committee this year, and on October 12 the drug was recommended for approval.
"It's a huge mistake", Wolfe said.