Notorious OxyContin-maker Purdue Pharma—which has been widely criticized for deceptively marketing its highly addictive painkiller and for its role in spurring the current nationwide epidemic of opioid abuse and overdose deaths—is moving ahead with a new, potent drug, one said to be an antidote to opioid overdoses.
The company announced this week that the US Food and Drug Administration has granted fast-track status to its investigational drug nalmefene hydrochloride (HCl), an injectable, emergency treatment intended to rescue people suspected of having an opioid overdose. Purdue suggests that nalmefene HCl’s effects last longer than the similar emergency opioid antagonist naloxone. As such, the company hopes nalmefene HCl will out-compete naloxone at reversing overdoses from the most highly potent opioid, namely fentanyl, which is currently driving the alarming numbers of opioid overdose deaths. The FDA’s fast-track status will speed the development and regulatory review of the drug.
“Opioid antagonists like naloxone have played an important role in the emergency treatment of opioid overdose,” John Renger, Purdue’s head of Research & Development and Regulatory Affairs, said in a statement. “However, because of the increasing number of deaths due to fentanyl and its even more potent analogues, we are focusing on a potentially more potent and longer-lasting rescue option specifically intended to work in those overdose situations.”