A Highly Addictive new Opioid, Stronger Than Fentanyl and Morphine, is Poised to be Approved by the FDA

In a controversial move, the U.S. Food and Drug Administration (FDA) is moving toward finalizing the approval of a highly addictive opioid. The decision was made by the FDA's advisory committee on October 12, where a 10–3 vote occurred in favor of the drug hitting the market.

"We are pleased with the Advisory Committee's recommendation to approve DSUVIA as a treatment in medically supervised settings for adults experiencing moderate-to-severe acute pain," Dr. Pamela Palmer, Co-Founder and Chief Medical Officer of AcelRx said in a news release. "We look forward to continued collaboration with the FDA on the application as we believe DSUVIA represents an important non-invasive acute pain management option with potential to significantly improve the current standard of care."

DSUVIA, the drug in question, is a form of Sufentanil—which is more potent than fentanyl and morphine. It would be sold as an under-the-tongue tablet. While it can treat pain, it's associated with a high risk for addiction and being dependent upon it. Side effects include but aren't limited to restlessness, muscle spasms, chest pain and fast heartbeat, according to PubMed Health.

Anaesthesiologist Raeford Brown of the University of Kentucky, who is also a committee chair, penned a letter Thursday opposing the FDA's approval. The letter was also signed by Sidney M. Wolfe, Meena M. Aladdin and Michael A. Carome of Public Citizen's Health Research Group.

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FDA Nearing Approval of New Opioid
The FDA is nearing an approval of a new opioid. Here, Oxycodone pain pills prescribed for a patient with chronic pain lie on display on March 23, 2016, in Norwich, CT. John Moore/Getty Images

"The agency feels that there is a capability, so far not demonstrated, to regulate this drug so that it is used only in closely controlled settings," the letter read. "In order to have this happen, the education of all prescribers would need to be guaranteed."

The letter continued, "This has not been demonstrated with any other opioid and, given the lack of teeth in the current risk evaluation and mitigation strategies for opioids, there is currently no educational nor regulatory scheme that will guarantee that this drug will be used only as described in the label."

America is in the midst of an opioid crisis. According to the National Institute on Drug Abuse (NIDA), an estimated 21 to 29 percent of individuals who hold an opioid prescription improperly use the medication. Out of the 21 to 29 percent of people who misuse the drug, about 4 to 6 percent will use heroin.

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President Donald Trump and his administration have called attention to the country's opioid crisis. In doing so, he's declared the issue to be a Public Health Emergency.

"It is time to liberate our communities from this scourge of drug addiction," Trump, 72, said in October 2017 during a speech at the White House. "I am directing all executive agencies to use every appropriate emergency authority to fight the opioid crisis."

A Highly Addictive new Opioid, Stronger Than Fentanyl and Morphine, is Poised to be Approved by the FDA | U.S.