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FDA grants fast track designation to Revex for opioid overdose
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The FDA granted Revex fast track designation for the emergency treatment of known or suspected opioid overdose, according to a press release issued by the drug’s manufacturer.
“Fentanyl and illicit opioid deaths continue to increase in the United States, fueled increasingly by overdoses of this class of compounds,” Craig Landau, MD, president and CEO of Purdue Pharma, said in the release. “We urgently need new and potentially more effective treatments to combat opioid overdose than are available today.”
Revex (nalmefene hydrochloride [HCl] injection, Purdue Pharma) remains effective longer than Narcan (naloxone, Adapt Pharma), according to the release. Nalmefene HCl injection may be an important alternative to naloxone for treating opioid overdose if it is approved, according to the release.
“The fast track designation from the FDA for nalmefene HCl underscores the importance and time sensitivity of this unmet medical need,” Landau said. “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.”
The fast track designation was based on data from the investigational new drug application for nalmefene HCl which became effective Jan. 16, 2019, as well as expected efficacy and safety data from undergoing clinical trials, according to the release.
“Opioid antagonists like naloxone have played an important role in the emergency treatment of opioid overdose,” John Renger, PhD, vice president and head of research and development and regulatory affairs at Purdue Pharma, said in the release. “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.”
Disclosures: Landau and Renger are employed by Purdue Pharma.