The infamous OxyContin-maker Purdue Pharma – which has been widely criticized for deceivingly marketed its highly addictive painkiller and its role in stimulating the current national epidemic of opiate abuse and overdose death – is moving forward with a new potent drug, said to be an antidote to opioid overdoses.
The company announced this week that the US Food and Drug Administration has granted accelerated status to its experimental drug nalmefene hydrochloride (HCl), an injectable emergency treatment designed to rescue people suspected of opioid overdose. Purdue suggests that the effects of nalmefene HCl last longer than the similar emergency opioid antagonist naloxone. As such, the company hopes that nalmefene HCl will outperform naloxone in the case of highly potent opioid overdoses, namely fentanyl, which is currently driving the alarming number of opioid overdose deaths. The FDA's rapid progress will accelerate drug development and regulatory review.
"Opioid antagonists such as naloxone have played an important role in the emergency treatment of opioid overdose," Purdue head of research and development and regulatory affairs said in a statement. "However, due to the increasing number of deaths due to fentanyl and its even more powerful analogues, we are focusing on a potentially more powerful and more durable rescue option, specifically designed to work in those overdose situations."
The deaths of the extremely powerful fentanyl started popping up nationally in 2013. In 2017, synthetic narcotics (mainly fentanyl) were behind about 40% of the over 70,200 overdose deaths in the country. The sharp increase in the use of fentanyl and overdoses has followed a fourfold use and prescription opiate overdose, such as OxyContin. With the emergence of the crisis, the opiate prescription stabilized and began to decline in 2012, leading to an increase in the illicit use of fentanyl and heroin.
In the midst of the crisis, Purdue was harshly condemned for initially downplaying the dependence of OxyContin, which began to aggressively commercialize in the mid-1990s, earning billions of dollars in sales. In 2007, the company and three executives pleaded guilty in federal court to criminal charges that deceived doctors, patients and regulators for drug dependence. Since then, Purdue has been punched by lawsuits that blame the company for helping to stimulate the increase in opioid abuse and overdose. The company has defended itself against the accusations, but is now considering the possibility of declaring bankruptcy, which would mitigate the stroke of litigation and sentences.
"What is right"
In this week's statement, Purdue once again distanced itself from any involvement in starting the epidemic, focusing exclusively on the use of illicit drugs. Purdue president and CEO Craig Landau has been quoted as describing the problem simply as "Fentanyl and opioid illicit deaths continue to increase in the United States, fueled increasingly by overdoses of this class of compounds".
In a recent interview with the Washington Post, Landau said he expected Purdue's efforts to treat opiate overdoses to be criticized, saying:
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.
In keeping with this sentiment, Purdue has announced that it does not intend to make money with the new drug. "As part of Purdue's commitment to put forward meaningful solutions to address the opioid crisis, the company will work to advance this option with the commitment not to profit from any future sales of this drug."
Yet according to Purdue internal discussions that were made public in a lawsuit filed by the Massachusetts Commonwealth, Purdue and members of the wealthy Sackler family that owns the company had carefully studied the economic potential of treatments aimed at reversing the epidemic.
An unedited section of the case describes a secret plan called Project Tango, which explored Purdue's expansion in the sale of treatment options. The lawsuit states that Purdue and a member of the Sackler family determined that the millions of people who had become addicted to opioids constituted a primary business opportunity. Purdue staff wrote in the internal documents cited in the case that "It is an attractive market. Great unmet need for population of vulnerable, underdeveloped and stigmatized patients suffering from substance abuse, addiction and addiction."