FDA panel backs over-the-counter use of Emergent BioSolutions’ Narcan

The US Food and Drug Administration's (FDA’s) panel of advisors has unanimously voted in favour of an over-the-counter (OTC) version of Emergent BioSolutions’ opioid overdose-reversing drug.

If approved, Narcan (naloxone HCl) nasal spray will be the first opioid overdose medicine to be sold OTC nationwide, significantly expanding access to the life-saving treatment.

Paul Williams, senior vice president and products business head at Emergent BioSolutions said: "This favourable recommendation marks another important step forward to broaden access to Narcan nasal spray for those who may be at risk of an opioid overdose.”

Opioids are commonly used for the treatment of pain and include medicines such as morphine, fentanyl and tramadol.

However, due to their pharmacological effects, the drugs can cause breathing difficulties and opioid overdose can lead to death.

The number of overdoses has increased in recent years in several countries, partly due to the increased use of opioids in the management of chronic pain and increasing use of highly potent opioids appearing on the illegal drug market.

According to the US Centers for Disease Control and Prevention, more than 107,000 Americans died from a drug overdose in 2021, of which over 70,000 were as a result of using synthetic opioids containing fentanyl.

Narcan, which was developed to be used at home without the need for any medical training, works by blocking the effects of an opioid overdose if administered in time. However, it is currently only available in the US as a prescription medicine.

Dr Joshua Lynch, clinical associate professor of emergency and addiction medicine, the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, said: "Bystanders are present at nearly half of fatal overdoses, yet naloxone is administered in only a small percentage of those cases.

"The reality is accidental overdoses can happen to anyone, anywhere, at any time, and we can all do our part by being prepared to help like we would in any other emergency. With access to OTC naloxone, we would have a critical opportunity to close this gap and reduce the number of opioid-related deaths.”

While not obligated to do so, the FDA typically follows the recommendations of its expert panel and is expected to make its final decision on prescription-free sale of Narcan by 29 March.