FDA Approves Another Powerful Opioid Despite the Continual Rise in Opioid-Related Deaths

On Friday, November 2nd the Food and Drug Administration (FDA) approved the new pharmaceutical drug Dsuvia which is an extremely high strength opioid. The potent painkiller is 500 to 1,000 times more powerful than Morphine and 10 times stronger than one of the strongest opioids, fentanyl.

Dsuvia is an extremely powerful, fast-acting sublingual formulation of the synthetic opioid sufentanil. The FDA approved the use of the drug in limited, medically-supervised settings such as emergency rooms, hospitals, and surgery centers. The drug is not to be used for a period lasting longer than 72 hours and will not be available in retail pharmacies for take-home use. In an effort try and curb abuse of the drug it comes in a pre-packaged single dose applicator.

“… 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…”

Despite the FDA’s claims that the new drug will have very tight restrictions set in place for its use, concerns have been raised due to the current rates of opioid-related deaths in the United States. Massachusetts’ Democratic Senator Ed Markey openly opposed the approval of the drug stating that “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.” Markey also went on to say that “This drug offers no advance, in my mind, over previously available opioid formulations, but provides great risk of harm to patients and the general public health.”

The chairman of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) Dr. Raeford Brown also openly opposed the release of the new drug. He expressed doubts about the FDA’s ability to follow through with the regulations set in place for the drug. If a drug like this were to get into the wrong hands or make it onto the streets, the consequences could be devastating.

Preliminary estimates from the Centers for Disease Control (CDC) place 2017’s drug overdose death count around 72,000. A majority of those deaths involved some form of opioid that was either illicit or prescribed. According to the CDC, a large percentage of deaths related to opioids involved some form of the potent opioid fentanyl.

According to the new drug’s official website “Accidental exposure to or ingestion of DSUVIA, especially in children, can result in respiratory depression and death.” Even a brief scan through the side effects and warnings listed on the site make it very clear that this is a potentially deadly medication with a high risk of negative side effects. Another warning clearly states: “Serious, life-threatening, or fatal respiratory depression may occur with use of DSUVIA. Monitor for respiratory depression, especially during initiation of DSUVIA.”

Only time will tell how the release of Dsuvia will impact the current opioid crisis that the United States is currently facing. The new drug is scheduled to be released around the beginning of the new year.

Sources:

• USA Today
• Food and Drug Administration
• Official Dsuvia Webpage
• CDC: Provisional Drug Overdose Death Counts
• New York Times: Bleak New Estimates in Drug Epidemic: A Record 72,000 Overdose Deaths in 2017
• Senator Markey Urges FDA to Deny Approval of Powerful Opioid Dsuvia, Cites Warning of Committee Chair
• Rolling Stone: Could New Drug Approved by FDA Make the Opioid Epidemic Worse?