The company whose drugs are at the center of America’s deadly opioid epidemic was given a green light Wednesday to accelerate the development of a new opioid antidote.
The US Food and Drug Administration granted Purdue Pharma’s experimental opioid overdose drug fast-track designation. According to Purdue, its drug, nalmefene hydrochloride injection, has a longer effect than naloxone, another opioid antagonist that is approved to reverse overdoses.
The FDA’s fast-track designation facilitates the development and expedites the review of drugs that treat serious conditions and fill an unmet medical need. “If approved, the duration of effect of nalmefene HCl injection has the potential to serve as an important alternative for the treatment of opioid overdose,” Purdue said in a statement.
In 2017, over 47,000 US drug overdose deaths were attributed to opioids, and more than half involved synthetic narcotics, like illicit fentanyl.
“The Fast Track designation from the FDA for nalmefene HCl underscores the importance and time sensitivity of this unmet medical need. We will continue our efforts to make nalmefene HCl injection available as quickly as possible, as it has the potential to be an important option to help address this public health emergency,” Dr. Craig Landau, president and CEO of Purdue Pharma, said in a statement.
The company said it is committed to advancing solutions to the opioid crisis, and “Purdue will not profit from nalmefene HCI.”
Purdue Pharma, which is privately owned by the Sackler family, is named as a plaintiff in dozens of lawsuits across the country for its role in contributing to one of the country’s worst drug crises. The Sacklers and Purdue have been accused of aggressively marketing OxyContin using deceptive sales and marketing practices and downplaying its abusive and addictive properties.
In a complaint brought by the state of Massachusetts, the prosecution argued that “From the beginning, the Sacklers viewed limits on opioids as an obstacle to greater profits. To make more money, the Sacklers considered whether they could sell OxyContin in some countries as an uncontrolled drug.”
In a previous statement to CNN, Purdue has said that the accusations “irresponsibly and counterproductively casts every prescription of OxyContin as dangerous and illegitimate, substituting its lawyers’ sensational allegations for the expert scientific determinations of the Food and Drug Administration (FDA) and completely ignoring the millions of patients who are prescribed Purdue Pharma’s medicines for the management of their severe chronic pain.”
Between 1999 and 2011, the overdose death rate from prescription opioids like OxyContin, a brand-name version of oxycodone, quadrupled. According to the US Centers for Disease Control and Prevention, oxycodone, hydrocodone and methadone are the among the most common drugs involved in prescription opioid overdose fatalities. These opioid drugs are chemically similar to heroin and fentanyl. Nearly 80% of Americans using heroin start by misusing prescription opioids.
According to Forbes, the Sackler family is one of the country’s wealthiest, worth approximately $13 billion, and is well-known for their philanthropy.
In an interview with the Washington Post this week, Landau said that bankruptcy is an option for the company. “We are considering it, but we’ve really made no decisions on what course of actions to pursue. A lot depends on what unfolds in the weeks and months ahead,” he said.