“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,” – MA Senator Ed Markey.

Despite the nation’s rampant opioid crisis, the FDA recently approved Dsuvia, a new drug that is five to 10 times stronger than fentanyl, an opioid already on the market and one that is widely produced illegally. Fentanyl is responsible for many opioid deaths, mainly because patients don’t know that the opioids they are using contain it. As if that is not enough, Dsuvia can be up to 1,000 times more powerful than morphine.

The makers of Dsuvia, AcelRx Pharmaceuticals, say this opioid is only intended for use under strict medical supervision in a medical setting. However, every day, nearly 200 people die from opioid abuse, the equivalent of a plane crash.

As with any drug, AcelRX claims that Dsuvia fills an unmet need because it is a sublingual (a dissolvable tablet that is put under the tongue) drug. The company’s chief medical officer Dr. Pamela Parker told ABC News that it has been many years since an opioid was developed for hospital management of acute pain. The options now are injectable painkillers or an oral pain pill that may take an hour to begin working. Because Dsuvia is a sublingual medication, it begins working immediately in crisis situations. Palmer was also quick to point out that Dsuvia will likely help prevent dosing errors that frequently occur when liquid opioids are dispensed.

The U.S. Food and Drug Administration’s Commissioner Dr. Scott Gottlieb joined Palmer in defending his agency’s approval of Dsuvia. Gottlieb stated that the drug’s unique aspects make it a welcome addition to hospitals. The commissioner in particular cited Dsuvia’s potential military use, saying the drug could help soldiers who cannot be given intravenous opioids.

Not everyone at the FDA shares in Gottlieb’s opinion. Dr. Raeford Brown chairs the FDA’s advisory committee on analgesics and anesthetics and was not present at the FDA vote but said he has significant concerns about placing such a potent opioid on the market. Brown stated the FDA’s final decision disappointed him. With more than 200 million opioid prescriptions written in the United States each year, Brown could not understand why Dsuvia was even necessary.

Staunch critics like Dr. Sidney Wolfe of the Public Citizen’s Health Research Group made his opposition known in a press release, saying that Dsuvia will only worsen the already burgeoning opioid crisis.

AcelRx states it has put measures in place to ensure the drug is not abused, such as stricter monitoring of manufacturers, distributors and hospitals. The company has contracted with Denver Health, a group that offers several programs to monitor prescription drug abuse and diversion. But the reality is quite different; once opioids are released into the market, there is actually very little, if any, control on the drugs to guard against misuse and abuse.

Congress has taken notice and expressed concern. Massachusetts has some of the nation’s highest opioid overdose rates, and Democratic Senator Ed Markey said in a press release that it made absolutely no sense that the FDA would release an opioid 1,000 times more powerful than morphine: “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.”

 

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