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Tag: sufentanil

  • Opioid 10 Times Stonger Than Fentanyl Approved By FDA Amid Controversy

    Opioid 10 Times Stonger Than Fentanyl Approved By FDA Amid Controversy

    “It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” said one critical health expert. 

    Amid controversy and despite warnings from some in the medical community, the Food and Drug Administration (FDA) last week green-lit a new opioid called Dsuvia, a drug estimated to be 10 times as strong as fentanyl. 

    The powerful painkiller is an under-the-tongue version of sufentanil, available in a pre-filled single-dose applicator, according to the federal agency. In theory, it would be used in hospitals, surgery centers and emergency departments.

    Though it wouldn’t be available for take-home prescriptions, some worry that it will be diverted and abused—to deadly effect.

    “It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” Dr. Sidney Wolfe of Public Citizen’s Health Research Group said in a press release. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.”

    FDA Commissioner Scott Gottlieb released a statement defending his agency’s decision, highlighting the drug’s potential for use in war in light of its specific packaging and formulation.

    Because it is sublingual, the painkiller doesn’t necessitate venous access and doesn’t require that the patient be alert enough to swallow. That could make it incredibly useful in extreme emergency situations, such as on the battlefield—and that’s what drew the Department of Defense to take interest in the drug. 

    “This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield,” Gottlieb wrote.

    Indeed, the Pentagon has poured millions of dollars in funding research by AcelRx, the drug company behind Dsuvia, according to the Washington Post.

    Despite the assurances Gottlieb sought to offer, his agency generated controversy not just for its decision to approve the drug, but also for the way in which they did it.

    The FDA advisory committee that recommended allowing the painkiller voted 10-3 in favor of the drug—even though committee chair Dr. Raeford Brown was out of town speaking at a medical conference, according to the Washington Post.

    Brown condemned the decision, raising concerns about the efficacy data and the sponsor’s response to safety questions.

    “Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect,” Brown wrote. “I will continue to hold the agency accountable for their response to the worst public health problem since the 1918 influenza epidemic.”

    View the original article at thefix.com

  • New Opioid 500 Times Stronger Than Morphine Nears FDA Approval

    New Opioid 500 Times Stronger Than Morphine Nears FDA Approval

    Sufentanil is currently used intravenously in operating rooms in tightly-controlled circumstances.

    The chair of an FDA advisory panel is speaking out against the approval of a powerful new opioid that is even stronger than fentanyl, but despite his public stances it appears likely that the FDA will approve the drug. 

    “Opioids are substantially different than almost any other classification of drugs in that they carry with them the risks of tolerance, addiction, and death, and what we’ve been trying to get the FDA to come to grips with is that this class of drugs needs to be treated differently,” Raeford Brown, Jr., MD, chair of the Anesthetic and Analgesic Drug Products Advisory Committee and professor at the University of Kentucky told MedPage Today. “Some of the methodology they use to manage other drug classes are perhaps not reasonable with this.”

    The drug in question is DSUVIA, a form of sufentanil, a synthetic opioid that is 500 times more powerful than morphine. Sufentanil is currently used intravenously in operating rooms in tightly-controlled circumstances, but DSUVIA would make it available in a tablet that is administered under the tongue.

    On Oct. 12, the FDA’s advising committee voted 10-3 to allow the drug to go to market. 

    However, Brown said that many committee members — himself included — were absent for that vote because they were attending the American Society of Anesthesiologists conference.

    “That’s one of the reasons I felt that I needed to speak up, because people that are regulating this drug need to be very thoughtful about the public health in this particular circumstance,” he said.

    The drug would be approved with a Risk Evaluation and Mitigation Strategy (REMS) program, but Brown said that is not enough of a safeguard. 

    “There’s no indication whatsoever that any of the REMS programs for opioids have been effective in improving the safety,” he said. 

    Brown is so against the approval of DSUVIA that he penned an open letter to the FDA, saying that sufentanil has “substantial risks of respiratory depression, diversion, abuse, and death,” and that its benefits do not outweigh these risks.  

    “It is my observation that once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health,” he wrote. “Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been post-marketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market.”

    Further information on the approval of DSUVIA is expected in early November. 

    View the original article at thefix.com