EPeak Daily

After pushing addictive OxyContin, Purdue now pursuing overdose antidote

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Enlarge / If authorised, Purdue’s new drug would compete with opioid overdose antidote, naloxone.

Infamous OxyContin-maker Purdue Pharma—which has been extensively criticized for deceptively advertising its extremely addictive painkiller and for its position in spurring the present nationwide epidemic of opioid abuse and overdose deaths—is shifting forward with a brand new, potent drug, one mentioned to be an antidote to opioid overdoses.

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The corporate introduced this week that the US Meals and Drug Administration has granted fast-track standing to its investigational drug nalmefene hydrochloride (HCl), an injectable, emergency therapy meant to rescue folks suspected of getting an opioid overdose. Purdue means that nalmefene HCl’s results last more than the same emergency opioid antagonist naloxone. As such, the corporate hopes nalmefene HCl will out-compete naloxone at reversing overdoses from probably the most extremely potent opioid, specifically fentanyl, which is at present driving the alarming numbers of opioid overdose deaths. The FDA’s fast-track standing will pace the event and regulatory evaluation of the drug.

“Opioid antagonists like naloxone have performed an necessary position within the emergency therapy of opioid overdose,” John Renger, Purdue’s head of Analysis & Growth and Regulatory Affairs, mentioned in a press release. “Nonetheless, due to the growing variety of deaths as a consequence of fentanyl and its much more potent analogues, we’re specializing in a probably stronger and longer-lasting rescue choice particularly meant to work in these overdose conditions.”

Deaths from the extraordinarily potent fentanyl started spiking nationwide in 2013. In 2017, artificial narcotics (primarily fentanyl) had been behind roughly 40 p.c of the greater than 70,200 overdose deaths within the nation. The abrupt rise of fentanyl use and overdoses adopted a quadrupling of use and overdoses from prescription opioids, similar to OxyContin. Because the disaster got here to mild, opioid prescribing leveled off and commenced declining in 2012, resulting in the rise of illicit fentanyl and heroin use.

Amid the disaster, Purdue has been fiercely condemned for initially downplaying the addictiveness of OxyContin, which it started aggressively advertising within the mid-1990s, incomes the corporate billions of {dollars} in gross sales. In 2007, the corporate and three executives pleaded responsible in federal court docket to legal prices that they deceived medical doctors, sufferers, and regulators over the addictiveness of the drug.  Since then, Purdue has been pummeled by lawsuits blaming the corporate for serving to to spur the rise in opioid abuse and overdoses. The corporate has vigorously defended itself towards the claims however is now contemplating submitting for chapter, which might soften the blow of litigation and judgments.

“What’s proper”

Within the assertion this week, Purdue as soon as once more side-stepped any involvement in initiating the epidemic, focusing solely on illicit drug use. Purdue’s president and CEO, Craig Landau was quoted as describing the issue merely as “Fentanyl and illicit opioid deaths proceed to extend in the USA, fueled more and more by overdoses of this class of compounds.”

In a current interview with the Washington Submit, Landau mentioned he anticipated Purdue’s efforts to deal with opioid overdoses can be criticized, saying:

I acknowledge every little thing we do will probably be criticized on this regard, however ultimately we’re going to do what’s proper. These are good issues that would and will have a constructive affect on public well being and on sufferers.

According to that sentiment, Purdue introduced that it doesn’t intend to earn money on the brand new drug. “As a part of Purdue’s dedication to advance significant options to handle the opioid disaster, the corporate will work to carry ahead this feature with the dedication to not revenue from any future gross sales of this drug.”

Nonetheless, in accordance with inside discussions at Purdue that had been made public in a lawsuit introduced by the Commonwealth of Massachusetts, Purdue and members of the rich Sackler household that owns the corporate had rigorously researched the money-making potential of therapies geared toward reversing the epidemic.

An un-redacted part of the lawsuit describes a secret plan referred to as Challenge Tango, which explored Purdue’s enlargement into promoting therapy choices. The lawsuit states that Purdue and a member of the Sackler household decided that the tens of millions of people that had grow to be hooked on opioids had been a main enterprise alternative. Purdue workers wrote in inside paperwork quoted within the lawsuit that “It’s a horny market. Massive unmet want for susceptible, underserved and stigmatized affected person inhabitants affected by substance abuse, dependence and dependancy.”

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