Gaithersburg, Maryland-based biotech Emergent BioSolutions stands to gain from a Food and Drug Administration decision to make opioid overdose drug Narcan available without a prescription. It makes the nasal spray version of the opioid-overdose antidote, naloxone.
Gaithersburg, Maryland-based biotech Emergent BioSolutions stands to gain from a Food and Drug Administration decision to make opioid overdose drug Narcan available without a prescription. It makes the nasal spray version of the opioid-overdose antidote naloxone.
An FDA advisory panel this week recommended over-the-counter availability of Narcan. While the FDA is not required to follow any recommendations from advisory panels, it usually does.
Emergent BioSolutions stock jumped as much as 20% in Thursday morning trading.
In December, the company received fast-track review status for making Narcan available without a prescription. That priority review status means the FDA is expected to issue a decision on March 29.
All versions of naloxone, including an injectable version, currently require a prescription. though access laws allow paramedics and other first responders to carry it. All 50 states have standing orders that also allow pharmacies to dispense the drug without a doctor’s prescription to other authorized individuals.
“This favorable recommendation marks another important step forward to broaden access to Narcan nasal spray for those who may be at risk of an opioid overdoes,” said Paul Williams, senior vice president and products business head at Emergent after the FDA’s recommendation.
He said the decision “reaffirms our confidence in the safe and effective use of Narcan in the community setting.”
Deaths related to synthetic opioids, namely fentanyl, increased 60% from 2019 to 2020 in the U.S., according to the Centers for Disease Control and Prevention. In 2021, more than 71,000 people in the U.S. died from opioids containing fentanyl.
Emergent gained rights to Narcan as part of its 2018 acquisition of Adapt Pharma. Since then it has distributed millions of prescription Narcan devices to national, state and local health departments and first responders, public health clinics, fire departments and police departments.
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