Notorious OxyContin maker Purdue Pharma – who has been widely criticized for fraudulently marketing his highly addictive painkiller and for his role in stimulating the current nationwide epidemic of opioid abuse and overdose ̵
The company announced this week that the US Food and Drug Administration has granted rapid tracing status to its investigative drug shortcut hydrochloride (HCl), an injectable emergency treatment designed to rescue people suspected of having an opioid overdose. Purdue suggests that the nalmefene-HCl effects persist longer than the corresponding acutopioid antagonist naloxone. As such, the company hopes that nalmefenehCl will compete for naloxone in reversing overdoses from the strongest potent opioid, namely fentanyl, currently driving the alarming number of opioid doses. The FDA's Fast Track Status will accelerate drug development and regulatory review.
"Opioid antagonists such as naloxone have played an important role in the acute treatment of opioid overdose," said John Renger, Purdue's director of research and development and regulatory affairs, in a statement. "Due to the increasing number of fentanyl and its deaths, even stronger analogues, we focus on a potentially more potent and prolonged rescue option specifically intended to work in such overdose situations. "Deaths from extremely potent fentanyl began spiking nationwide in 2013. In 2017, synthetic drugs (mainly fentanyl) were behind about 40 The abrupt increase in fentanyl use and overdoses followed a four-fold increase in the use and overdose of prescription opioids, such as OxyContin, when the crisis revealed the opioid writing and began to decline in 2012, leading to the increase of illicit fentanyl and heroin use
In the crisis, Purdue has been condemned to initially reduce the experience of OxyContin, which it began to aggressively market in the mid-1990s and earned the company billions of dollars in sales. In 2007, the company and three executives pleaded guilty to the federal court for criminal charges that they deceived doctors, patients, and regulators of drug addictions. Since then, Purdue has been pummeled by trials blaming the company to help stimulate the rise of opioid abuse and overdoses. The company has strongly defended itself against the claims, but is now considering applying for bankruptcy, which would mitigate the kind of disputes and judgments.
In the statement this week, Purdue once again returned to the commitment to initiate the epidemic, focusing solely on illicit drug use. Purdue's President and CEO, Craig Landau, was quoted as describing the problem simply as "Fentanyl and illegal opioid deaths continue to increase in the United States, driven increasingly by overdoses of this class of associations."
In a recent interview with Washington Post Landau said he expected Purdue's efforts to treat opioid overdoses would be criticized and say:
I recognize everything we do will be criticized in this regard, but in the end we will do what is right. These are good things that can and should have a positive impact on public health and on patients.
In line with that feeling, Purdue announced that it does not intend to make money on the new drug. "As part of Purdue's commitment to promoting meaningful solutions to managing the opioid crisis, the company will work to bring this alternative to the commitment not to benefit from any future sales of this drug."
According to internal discussions in Purdue published in a process brought by the Commonwealth of Massachusetts, Purdue and the members of the rich Sackler family who own the company have carefully examined the money-making potential of treatments aimed at reversing the epidemic.
An unedited part of the trial describes a secret plan called Project Tango, which investigated Purdue's expansion to sell treatment options. The trial says that Purdue and a member of the Sackler family decided that the millions of people who had become addicted to opioids were an important business opportunity. Purdue staff wrote in internal documents cited in the trial that "it is an attractive market. Great unmet need for vulnerable, impaired and stigmatized patient population suffering from addiction, addiction and dependence."