Even in the best of cases, FDA expert hearings on the merits of a drug application are rarely a clean sweep. But that’s exactly what happened Wednesday.
At a meeting of the agency’s Nonprescription Drugs and Anesthetic and Analgesic Drug Products advisory committees, the FDA’s panel of 19 independent experts voted unanimously in favor of an over-the-counter nod for Emergent BioSolutions’ opioid overdose reversal drug Narcan. While the FDA is not beholden to the vote, it often follows the lead of its committee experts.
The FDA is set to decide on the OTC approval pivot by March 29. If cleared next month, Emergent’s Narcan—a nasal spray—would become the first naloxone to successfully transform its prescription-status approval into an over-the-counter one. Emergent was first to file with its supplemental application for an OTC nod and won priority review last December.
Aside from making Narcan easier to access at the pharmacy, an OTC green light could also facilitate sales of the medicine in convenience stores, big box stores, supermarkets and even vending machines, the FDA posited in a presentation released ahead of Wednesday’s meeting.
Apart from an OTC nod’s potential social benefit, Emergent’s sales stand to gain on the supplement approval for its drug. With generic naloxone from Teva and Sandoz now on tap in the U.S., Emergent’s Narcan revenues have already taken a hit. Back in 2022’s third quarter, the company’s naloxone sales slipped 34% to $87.9 million.
But an over-the-counter approval for Narcan could boost availability of Emergent’s branded product, potentially giving the legacy drug a unique edge over generics, which will need to separately apply for their own OTC nods.
“Bystanders are present at nearly half of fatal overdoses, yet naloxone is administered in only a small percentage of those cases,” Joshua Lynch, clinical associate professor of emergency and addiction medicine at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences, said in Emergent's press release. “With access to over-the-counter naloxone, we would have a critical opportunity to close this gap and reduce the number of opioid-related deaths."
More than 100,000 people in the U.S. died from drug overdoses in 2021, of which more than 70,000 stemmed from synthetic opioids containing fentanyl. As opioid-related deaths spike, there’s a pressing need to expand access to overdose reversal treatment, Emergent has argued.
To further make its case at Wednesday’s meeting, Emergent provided a deep-dive look at its over-the-counter development program. The company also presented data from “human factor” studies alongside seven years of postmarketing safety readouts.
At present, all 50 states have access laws allowing (PDF) pharmacists to dispense naloxone without a doctor’s prescription. Even still, access barriers persist, Emergent and the FDA have warned. “The current level of naloxone distribution does not match the number of at-risk patients,” Emergent argued in briefing documents released before the AdComm.
Current naloxone access laws have “led to confusion, particularly given the variability in state-level NALs and nuances of implementation,” Emergent said. The company contends misconceptions about naloxone’s prescription status are “often present” among healthcare professionals and public health officials.
Emergent argues its Narcan nasal spray meets all FDA requirements for the prescription-status switch: The drug is easy to use, doesn’t require a healthcare professional to administer and has low potential for misuse or abuse, and the benefits of increased access trump the potential risks.
The biggest concern raised by panelists was related to Narcan’s instructions and packaging, which caused confusion among some patients in a company study, according to the FDA’s own briefing documents. “The design of the entire user interface plays an important role in how effective the product is at reversing opioid-induced respiratory depression and preventing death and other serious outcomes,” the regulator said.
Emergent has indicated it will make packaging and instruction changes per the FDA’s suggestions.
Politicians and health officials have long called for improvements to naloxone access. Back in November, the FDA issued a preliminary endorsement that certain naloxone products “may be approvable” for over-the-counter use. At the time, the FDA singled out two “community-use” naloxone products—Kaleo’s prefilled autoinjector Evzio and Emergent’s nasal spray Narcan—as prime candidates to “inform the public health decisions for layperson use.”
And last September, President Joe Biden made beating the opioid epidemic a key pillar of his agenda in his first State of the Union address. Alongside more than $1.5 billion in total federal funding to support substance-use treatment and prevention, Biden’s plan includes new FDA guidance meant to ease distribution of approved naloxone with a specific focus on boosting access in underserved communities.