Medicine

FDA Approves Powerful Opioid Pill That’s 10 Times Stronger Than Fentanyl

FDA Approves Powerful Opioid Pill That’s 10 Times Stronger Than Fentanyl

In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a "danger" to public health.

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.

Dsuvia comes as a tablet in an applicator that health care providers administer under the tongue.

Accordingly, then, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted in favor, 10 to 3, of approval of this medication.

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. The most notable of these critics might actually be in-house: the chair of the FDA advisory committee, who also happens to be the chair for the consumer advocacy group Public Citizen.

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.

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One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement. 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.

Critics blasted the agency for bringing a new opioid to market as the nation faces increasing opioid overdose deaths in what many call a crisis.

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.

"DSUVIA will not be available in retail pharmacies or for outpatient use". And many of those will overdose and die. Angotti noted that the drug will be subject to a Risk Evaluation and Mitigation Strategy program.

"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.

The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill. According to Gottlieb, "This opioid formulation, along with Dsuvia's unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation's soldiers on the battlefield". Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it. The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment.