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FDA fast track OxyContin manufacturer's overdose drug



The US Food and Drug Administration granted Purdue Pharma's experimental opioid overdose medical quick tracking designation. According to Purdue, its drug, nalmefene hydrochloride injection, has a longer effect than naloxone, another opioid antagonist approved for reversing overdoses.

The FDA's rapid trace designation facilitates development and accelerates the review of drugs that treat serious conditions and fill an unsaturated medical need. "If approved, the effect of injection of nalmefene HCl has the potential to serve as an important alternative for the treatment of opioid overdose," Purdue said in a statement.

In 2017, over 47,000 US drug overdose deaths were attributed to opioids, and more than half involved synthetic drugs. , as the illegal fentanyl. "The FDA's Fast Track designation for nalmefene HCl emphasizes the importance and timing of this unheated medical need. We continue our efforts to make nalmefene HCl injection available as quickly as possible, as it has the potential to be an important alternative to helping address this public health situation, "says Craig Landau, President and CEO of Purdue Pharma. [1

9659005] The company said it is important to develop solutions for the opioid crisis and "Purdue will not profit from nalmefene HCI. "

Purdue Pharma, privately owned by the Sackler family, is named as the proprietor of dozens of trials across the country for its role in contributing to one of the country's worst drug crises. Sacklers and Purdue have been accused of aggressively marketing OxyContin using Fraudulent Sales and Marketing Methods and Playback of its Abusive and Addictive Features.

In a state complaint from Massachusetts, the prosecution claimed that "from the beginning, Sackler's opioid boundaries began as an obstacle to greater profits. To make more money, Sacklers judged whether they could sell OxyContin in some countries as an uncontrolled drug. "Purdue Pharma is seeking legal notice in Massachusetts" data-src-mini = "// cdn.cnn.com/cnnnext/dam/assets/170601100656-cnnmoney-oxycontin-small-169.jpg" data-src-xsmall = " //cdn.cnn.com/cnnnext/dam/assets/170601100656-cnnmoney-oxycontin-medium-plus-169.jpg "data-src-small =" http://cdn.cnn.com/cnnnext/dam/assets /170601100656-cnnmoney-oxycontin-large-169.jpg "data-src-medium =" // cdn.cnn.com/cnnnext/dam/assets/170601100656-cnnmoney-oxycontin-exlarge-169.jpg "data-src- large = "// cdn.cnn.com/cnnnext/dam/assets/170601100656-cnnmoney-oxycontin-super-169.jpg" data-src-full16x9 = "// cdn.cnn.com/cnnnext/dam/assets/ 170601100656-cnnmoney-oxycontin-full-169.jpg "data-src-mini1x1 =" // cdn.cnn.com/cnnnext/dam/assets/170601100656-cnnmoney-oxycontin-small-11.jpg "data-demand load = "not-loaded" data-eq-pts = "mini: 0, xsmall: 221, small: 308, medium: 461, large: 781" src = "data: image / gif; // wAAACH5BAEAAAIALAAAAAAQAAkAAAIKlI + py + 0Po5yUFQA7 "/>
In a previous statement to CNN, Purdue has said that the allegations "irresponsibly and counteractingly throw any recipe for OxyContin as dangerous and illegal, replacing their lawyers' sensational claims for the scientific and scientific findings of the Food and Drug Administration (FDA) and completely ignore the millions of patients prescribed Purdue Pharma drugs to manage their severe chronic pain. "
Between 1999 and 2011, overdosage rate from prescription opioids such as OxyContin, a brand version of oxycodone, quadrupled. According to the US Centers for Disease Control and Prevention, oxycodone, hydrocodone and methadone are among the most common drugs involved in prescription opioid doses. These opioid drugs are chemically similar to heroin and fentanyl, with almost 80% of Americans using heroin starting to abuse prescription opioids.
According to Forbes, the Sackler family is one of the nation's richest, worth about $ 13 billion, and is well-known for its philanthropy
In an interview with the Washington Post this week, Landau said bankruptcy is an option for the company. "We are considering it, but we really have not made any decisions on what action to take. Much depends on what is developing during the weeks and months ahead, "he said.

CNN's Tony Marco and Lauren del Valle contributed to this report.


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