Ultra-Powerful Opioid Approved by FDA

Pearl Mccarthy
November 7, 2018

The Food and Drug Administration (FDA) is taking heat for approving a powerful, fast-acting opioid.

Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill". It's an alternative to IV painkillers used in hospitals.

"We need to address the question that I believe underlies the criticism raised in advance of this approval", Gottlieb wrote.

"To what extent should we evaluate each opioid exclusively on its own merits, and to what extent should we also consider. the epidemic of opioid misuse and abuse that's gripping our nation?"

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.

Also on Friday, the Drug Enforcement Administration released a report showing that prescription drugs were responsible for the most overdose deaths of any illicit drugs since 2001.

Gottlieb is committed to bringing a plan the FDA's Opioid Policy Steering Committee and maybe even the Congress.

The approval comes just a bit more than a year after President Donald Trump declared the opioid crisis a public health emergency.

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"In this way, [drug companies] would know up front where the opportunities are for developing new drugs that meet the FDA's standards for safety and effectiveness." .

The drug is a 30-microgram pill that packs the same punch as 5 milligrams of intravenous morphine, according to the Washington Post. Each would come in a plastic applicator that looks like a syringe.

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.

Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said. The drug's manufacturer, AcelRx, said the drug will be marketed with the name Dsuvia and cost between $50 and $60 per dose.

An FDA advisory committee did recommend for approval of Dsuvia in a 10-3 vote last month. Brown missed the meeting because he was speaking at a medical conference that day.

Dsuvia "works exactly the same as morphine and other opioids do", Alan says. "This action is inconsistent with the charter of the agency", Brown said in a statement Friday. Others weren't convinced that the drug's benefits outweighed potential risks. Fewer than 1 percent of people said they acquired opioids that way.

According to Gottlieb, there are very tight limitations for the use of the drug. The military wants to explore whether the pill can be used as a battlefield painkiller that is less cumbersome than liquid analgesics. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients. Most of that was the result of a record number of opioid-related deaths.

"It's a huge mistake", Wolfe said.

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