A new highly addictive opioid, stronger than fentanyl and morphine, is about to be approved by the FDA



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In a controversial move, the US Food and Drug Administration (FDA) is about to finalize the approval of a highly addictive opioid. The decision was made by the FDA Advisory Committee on October 12, where 10 out of 3 votes were voted in favor of marketing the drug.

"We are delighted with the advisory committee's recommendation to endorse DSUVIA as a medicalized treatment for adults with moderate to severe acute pain," said Dr. Pamela Palmer, co-founder and chief medical officer. AcelRx in a press release. . "We look forward to continuing collaboration with the FDA on the application, as we believe that DSUVIA represents an important non-invasive acute pain management option, likely to significantly improve current standards 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 a tablet under the tongue. Although it can treat pain, it is associated with a high risk of addiction and dependency. According to PubMed Health, side effects include, inter alia, agitation, muscle spasms, chest pain and fast heartbeats.

Anesthesiologist Raeford Brown of the University of Kentucky, who also chairs the committee, wrote Thursday a letter opposing FDA approval. The letter was also signed by Sidney M. Wolfe, Meena M. Aladdin and Michael A. Carome of the Citizen Public Health Research Group.

FDA is preparing to approve a new opioid The FDA is about to approve a new opioid. Here on March 23, 2016 in Norwich, Connecticut, oxycodone pain pills prescribed for a patient with chronic pain are on display. John Moore / Getty Images

"The agency believes that there is an ability, not demonstrated so far, to regulate this drug so that it is only used in tightly controlled settings," reads in. the letter. "For this to happen, we should guarantee the education of all prescribers".

The letter continues: "This has not been demonstrated with any other opioid and, given the lack of rigor in current opioid risk assessment and risk reduction strategies, there is currently no educational or regulatory regime in place. which guarantees that this drug will be used only as described in the label. "

America is in the middle of an opioid crisis. According to the National Institute for Combating Drug Abuse (NIDA), it is estimated that between 21 and 29% of people who hold an opioid prescription use it in a way inappropriate. Of the 21 to 29% of people who use drugs, about 4 to 6% will use heroin.

President Donald Trump and his administration have drawn attention to the opioid crisis in the country. In doing so, he stated that the problem was a public health emergency.

"It's time to free our communities from this scourge of addiction," said Trump, 72, in October 2017 during a speech at the White House. "I ask all executive agencies to use all appropriate emergency authorities to combat the opioid crisis."

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