قالب وردپرس درنا توس
Home / Business / A highly adjective new opioid, stronger than fentanyl and morphine, is expected to be approved by the FDA

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



In a controversial move, the US Food and Drug Administration (FDA) is moving ahead with the approval of a highly addictive opioid. The decision was made by the FDA Advisory Committee on October 12, where a 10: 3 vote was held in favor of the drug reaching the market.

"We are pleased with the recommendation of the Advisory Committee to authorize DSUVIA as a treatment in medically controlled environments for adults with moderate to severe acute pain," said Drs. Pamela Palmer, Co-Founder and Chief Medical Officer of AcelRx a Press Release. "We look forward to continued FDA collaboration with DSUVIA as we consider it an important non-invasive option for acute pain management that can significantly improve the current standard of care."

DSUVIA is the drug in question a form of sufentanil ̵

1; which is stronger than fentanyl and morphine. It would be sold as an under the tongue tablet. While it can treat pain, it is associated with and dependent on a high risk of dependency. Side effects include restlessness, muscle spasms, chest pain, and rapid heartbeat, according to PubMed Health.

The anesthesiologist Raeford Brown of the University of Kentucky, who is also chairman of the committee, wrote a letter on Thursday opposing FDA approval. The letter was also signed by Sidney M. Wolfe, Meena M. Aladdin and Michael A. Carome of the Public Citizen's Health Research Group. [194559005] <IMG itemprop = " contentUrl "width =" 961 "height =" 669 "class =" mapped-embed lazysize lazyload "src =" https://s.newsweek.com/sites/www.newsweek.com/files/styles/embed-lg/ public / 2018/10/20 / fda-nearing-approval-new-opioid.jpg "alt =" FDA soon to approve new opioid [19659006] The FDA is about to approve a new opioid, here are oxycodone pain pills used for A patient diagnosed with chronic pain was exhibited on March 23, 2016 in Norwich, CT. John Moore / Getty Images

"The authority has the feeling that there is a previously unproven ability to regulate this drug so that it will only be applied in the near future, controlled attitudes, "the letter read." To achieve this, the instructional

The letter continued, "This has not been proven in any other opioid, and given the lack of teeth in the current risk assessment and opioid mitigation strategies, there is currently no education or regulatory system that would warrant that this drug is only used as described on 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 people who hold an opioid prescription use the drug incorrectly, from 21 to 29 percent of people who are using the drug will use about 4 to 6 percent of heroin.

President Donald Trump and his government have called attention to the country's opioid crisis, turning the problem into a public health emergency

"It's time our communities rid of this scourge of drug addiction, "said Trump, 72, in a speech at the White House in October 2017." I mandate all executive agencies to use any appropriate emergency authority to combat the opioid crisis. "


Source link