FDA approves new, powerful drug amidst opioid crisis

FDA OKs powerful opioid pill as alternative to IV painkiller

More importantly, though, some critics argue that the drug's size (about 3mm wide) and potency (at least 10 times more powerful than fentanyl) will certainly have more appeal to those looking to misuse/abuse the drug or to sell it.

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. According to critics, the decision will only fuel the United States' drug crisis even further rather than improving it. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths.

Can the drug be prevented from being abused and misused? Dr. Palmer says that the drug will not be dispensed to patients via pharmacy; instead, it can only be administered by a healthcare provider in a medical center. 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. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001.

The drug, Dsuvia, is a quick-dissolve tablet designed as an alternative to the rapid-fire infusion of pain meds available via IV at a hospital.

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.

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The FDA also said it had signed a memorandum of understanding with the Defense Department to expedite availability of medical products, particularly those used to treat injuries in battlefield settings. The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical. A spokeswoman said the company is not providing information on expected sales. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.

An FDA advisory committee did recommend for approval of Dsuvia in a 10-3 vote last month.

"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain", Gottlieb said in an agency news release.

In a statement, he said, "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". The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment.

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