US health advisers are preparing to consider whether Emergent BioSolutions Inc.’s opioid overdose reversal drug is safe to sell without a prescription, a move hoped to raise access amid a surging death toll for the decades-long public-health crisis.
(Bloomberg) — US health advisers are preparing to consider whether Emergent BioSolutions Inc.’s opioid overdose reversal drug is safe to sell without a prescription, a move hoped to raise access amid a surging death toll for the decades-long public-health crisis.
Emergent will present findings to a joint meeting of two US Food and Drug Administration advisory panels Wednesday aimed at showing its nasal spray, sold under the brand name Narcan, can be used without oversight from a medical professional. Advice from the outside groups — the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee — isn’t binding, but the FDA frequently adopts their recommendations and has said it intends to return a decision by March 29.
Almost 81,000 Americans died from drug overdoses in 2021, an increase of about 10,000 from a year earlier, according to US health data. An over-the-counter version of Narcan, also known as naloxone, could remove barriers to the medication, a critical step endorsed by doctors, patient advocates, the FDA and members of Congress.
Naloxone “ought to be in every medicine cabinet in America right now,” Republican Representative Buddy Carter of Georgia said at a hearing last month. “I don’t want any barriers.”
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Pharmacists are authorized to dispense naloxone to anyone who needs it via states’ standing orders. Still, variations among the state rules can create confusion about who can order the drug and when. An over-the-counter option will ease access and help address stigma associated with asking for the medication, according to Bob Kramer, Emergent’s president and chief executive officer.
“It makes it easier, quite frankly, for someone to walk into one of the pharmacy chains and get immediate access,” he said in an interview.
Over-the-counter availability would increase naloxone sales by at least 15% and possibly as much as 179%, according to a 2019 study published in Health Services Research. Still, questions remain about how the shift would work.
Cheap generic versions of naloxone have been approved since 2019. A multi-step nasal spray costs about $85 and a single-step nasal spray costs about $150, according to the New York City health department. Many insurers also pay for the drug with minimal or no out-of-pocket patient costs. While making naloxone available without a prescription would likely reduce the product’s price and make it more available on pharmacy shelves, over-the-counter naloxone may not be covered by health insurance.
Every Second
“What we don’t want to have happen is there to be pricing shock in the market, where somebody who was historically getting ready access to Narcan at a reasonable price point — we don’t want that to increase,” Kramer said.
Products cleared for over-the-counter sale can’t be sold as prescription drugs. If Emergent’s over-the-counter Narcan receives approval, there will be a transition period during which it will be available alongside prescription nasal sprays, followed by a complete shift to nonprescription sales.
The FDA has been working to raise awareness of the potential switch and prevent shortages, according to a spokesperson. Other forms of naloxone, such as an injected version, will remain available via prescription.
Tens of thousands of lives have been saved by naloxone kits that were given to friends and family members to reverse opioid overdoses, US health data show. Making the medication available more widely can be a critical component of addressing the overdose epidemic, said Sarah Wakeman, medical director for the Massachusetts General Hospital’s Substance Use Disorder Initiative.
“In the era of illicitly manufactured fentanyl, where overdoses can happen so much more rapidly, really every second can count,” she said in an interview. “Making sure someone has naloxone in that moment is so crucial.”
–With assistance from Emma Court.
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