After pushing the OxyContin addiction, Purdue now pursues the overdose antidote



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When it was approved, the new drug from Purdue would compete with the antidote for opioid overdose, naloxone.
Enlarge / When it was approved, the new drug from Purdue would compete with the antidote for opioid overdose, naloxone.

Purdue Pharma, the famous manufacturer of OxyContin, which has been widely criticized for misleadingly commercializing its highly addictive painkiller and for its role in the development of the current national epidemic of drug abuse. Opioids and overdose deaths, goes from the front with a powerful new drug, an antidote to opioid overdoses.

The company announced this week that the US Food and Drug Administration has granted fast-track status to its experimental drug, Nalmefene Hydrochloride (HCl), an emergency injectable treatment to rescue people suspected of overdose. opioids. Purdue suggests that the effects of nalmefene hydrochloride last longer than those of naloxone, a similar emergency antagonist. As such, the company hopes that nalmefene HCl will outperform naloxone to overcome the overdoses of a very potent opioid, fentanyl, which is currently causing the alarming number of opioid overdose deaths. FDA's accelerated status will accelerate the development and regulatory review of the drug.

"Opioid antagonists such as naloxone have played an important role in the emergency treatment of opioid overdose," said John Renger, head of research and development and regulatory affairs at Purdue, in a statement. "However, because of the growing number of deaths from fentanyl and its even more powerful analogues, we are focusing on a potentially more powerful and longer-lasting rescue option specifically designed to work in overdose situations."

Deaths due to fentanyl, extremely potent, began to affect the country in 2013. In 2017, synthetic narcotics (mainly fentanyl) accounted for almost 40% of the more than 70,200 overdose deaths in the country. the country. The sudden increase in the use of fentanyl and overdoses followed a quadrupling of use and overdoses of opioid prescription, such as OxyContin. In light of the crisis, opioid prescriptions stabilized and began to decline in 2012, which resulted in an increase in the illicit consumption of fentanyl and heroin.

In the midst of the crisis, Purdue was strongly condemned for initially downplaying the addictive nature of OxyContin, which began trading aggressively in the mid-1990s, bringing in billions of dollars in sales. In 2007, the company and three leaders pleaded guilty in federal court to indicting doctors, patients and regulators for the drug's dependence. Since then, Purdue has been the victim of lawsuits, blaming the company for contributing to the rise of opioid abuse and overdoses. The company is vigorously defended against claims, but is now considering filing for bankruptcy, easing the burden of litigation and judgments.

"What is true"

In this week's statement, Purdue once again ruled out any involvement in triggering the outbreak, focusing solely on illicit drug use. Craig Landau, President and CEO of Purdue, would have described the problem simply as follows: "The number of deaths from fentanyl and illicit opioids continues to increase in the United States, fueled more and more by overdoses of this class of compounds. "

In a recent interview with the Washington Post, Landau said it expects Purdue's efforts to treat opioid overdoses to be criticized:

I recognize that everything we do will be criticized in this regard, but in the end, we will do what is right. These are good things that could and should have a positive impact on public health and patients.

True to this sentiment, Purdue announced that he did not intend to make money with the new drug. "As part of Purdue's commitment to provide concrete solutions to deal with the opioid crisis, the company will work to offer this option with a commitment to take no advantage of future sales of this drug."

Nonetheless, according to internal Purdue discussions that were made public in a lawsuit filed by the Commonwealth of Massachusetts, Purdue and members of the wealthy Sackler family, the company's owner, had carefully studied the financial potential of the treatments. to stop the epidemic.

An unredacted section of the lawsuit describes a secret plan called Project Tango, which explores the Purdue extension to the sale of treatment options. The lawsuit indicates that Purdue and a member of the Sackler family determined that the millions of people who had become opioid-dependent were a prime business opportunity. Purdue staff wrote in internal documents cited in the lawsuit: "This is an attractive market. Large unmet need for a population of vulnerable, underserved and stigmatized patients with substance abuse, addiction and addiction. "

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