The US Food and Drug Administration granted Purdue Pharma’s experimental opioid overdose medical quick tracking designation. According to Purdue, its drug, nalmefene hydrochloride injection, has a longer effect than naloxone, another opioid antagonist approved for reversing overdoses.
The FDA’s rapid trace designation facilitates development and accelerates the review of drugs that treat serious conditions and fill an unsaturated medical need. “If approved, the effect of injection of nalmefene HCl 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 drugs. , as the illegal fentanyl. “The FDA’s Fast Track designation for nalmefene HCl emphasizes the importance and timing of this unheated medical need. We continue our efforts to make nalmefene HCl injection available as quickly as possible, as it has the potential to be an important alternative to helping address this public health situation, “says Craig Landau, President and CEO of Purdue Pharma. [1
9659005] The company said it is important to develop solutions for the opioid crisis and “Purdue will not profit from nalmefene HCI. ”
Purdue Pharma, privately owned by the Sackler family, is named as the proprietor of dozens of trials across the country for its role in contributing to one of the country’s worst drug crises. Sacklers and Purdue have been accused of aggressively marketing OxyContin using Fraudulent Sales and Marketing Methods and Playback of its Abusive and Addictive Features.