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The US Food and Drug Administration has granted Purdue Pharma the rapid designation of an investigational drug for the treatment of opioid overdose. According to Purdue, her drug, nalmefene hydrochloride injection, has a longer effect than naloxone, another opioid antagonist approved to treat overdoses.
The FDA's rapid designation facilitates the development and review of drugs that treat serious diseases and address an unmet medical need. "If approved, the duration of effect of nalmefene HCl injection could be an important alternative for the treatment of opioid overdose," Purdue said in a statement.
In 2017, more than 47,000 drug overdose deaths in the United States were attributed to opioids and more than half involved synthetic narcotics, such as illicit fentanyl.
"The FDA Fast Track designation for nalmefene HCl underscores the temporal importance and sensitivity of this unmet medical need. We will continue our efforts to make the injection of nalmefene HCl available as quickly as possible as it may be an important option to help resolve this public health emergency, "said Dr. Craig Landau, President and CEO of Purdue Pharma, in a statement.
The company said it was determined to offer solutions to the opioid crisis and that "Purdue will not benefit from the nalmefene HCI".
Purdue Pharma, owned privately by the Sackler family, has been named a plaintiff in a dozen lawsuits across the country for its role in one of the country's worst drug crises. The Sacklers and Purdue have been accused of aggressive marketing of OxyContin through deceptive marketing and marketing practices and the minimization of its abusive and addictive properties.
In a lawsuit filed by the state of Mbadachusetts, the prosecution stated that "from the outset, the Sacklers considered the limits imposed on opioids as an obstacle to greater profits. To earn more money, the Sacklers have considered selling OxyContin in some countries. uncontrolled drug. "
In a previous statement to CNN, Purdue said the "irresponsible and counterproductive" charges make each OxyContin prescription a dangerous and illegitimate product, substituting sensational claims of its lawyers to the expert scientific determinations of the Food and Drug Administration (FDA) and completely ignoring the millions of patients who are prescribed Purdue Pharma drugs for the management of their severe chronic pain. "
Between 1999 and 2011, the overdose death rate of prescription opioids such as OxyContin, a branded brand oxycodone version, quadrupled. According to the US Centers for Disease Control and Prevention, oxycodone, hydrocodone, and methadone are among the most commonly implicated drugs in overdose prescription opioid deaths. These opioids are chemically similar to heroin and fentanyl. Nearly 80% of Americans consuming heroin start by abusing opioid prescription.
According to Forbes, the Sackler family is one of the richest in the country, worth about $ 13 billion, and is known for its philanthropy.
In an interview with the Washington Post this week, Landau said bankruptcy was an option for the company. "We are looking at it, but we have not really made any decisions about what to do, it all depends on what will happen in the weeks and months ahead," he said.
Tony Marco and Lauren del Valle from CNN contributed to this report.
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