A highly effective, fast-acting treatment for opioid overdoses will soon be available in the U.S. over-the-counter. On Wednesday, the Food and Drug Administration approved an OTC version of Narcan, a nasal spray formulation of naloxone developed by the company Emergent BioSolutions. Drug policy experts and harm reduction advocates have long called for OTC naloxone, but it’s expected to take months for the switch to be completed and other key details—particularly pricing—are still unknown at this time.
Naloxone is an opioid antagonist, meaning it blocks the effects of other opioids in our system. This allows it to rapidly reverse the symptoms of an opioid overdose, which include trouble breathing, faint heartbeat, and unconsciousness. The drug can be delivered intravenously, intramuscularly, or subcutaneously as a shot and via nasal spray.
In the midst of an ongoing drug overdose crisis, naloxone has emerged as a crucial tool for preventing opioid-related deaths. But despite efforts to expand naloxone access in recent years by community advocates and the government, supplies of the prescription drug have remained unsteady. As recently as mid-2022, for instance, there were long-running shortages of injectable naloxone throughout the U.S. These shortages now seem to be over, but many experts have argued that OTC naloxone would be an important step forward in ensuring the drug’s availability.
The FDA has been hesitant to approve an OTC version of injectable naloxone, but it has been pushing pharmaceutical companies to apply for the approval of a nasal spray OTC. Last December, Emergent—the creators of Narcan—announced that they had filed for such an approval and that they expected a decision by late March 2023. As expected, the FDA decided to give them the go-ahead for an OTC 4-milligram version of Narcan.
Powerful performanceThe M1 chip delivers 3.5x faster performance than the previous generation all while using way less power. Get up to 18 hours of battery life.
“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert Califf in a statement. “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country.”
In its announcement of the news, Emergent stated that it would take until late summer for Narcan to be sold in stores and online retailers. In the meantime, they added, it would remain available through current distribution channels, including community programs and pharmacies with standing orders (standing orders allow the drug to be sold without a doctor’s direct approval). The company, however, did not address the expected price of its OTC product.
Advocates have long criticized the higher list prices of Narcan relative to other formulations of naloxone, which can run as high as $140 or more for a two-pack. Though community and government programs have often been able to buy Narcan at lower costs, injectable naloxone has remained far cheaper (as low as $5 or less a dose), making it more affordable and reliable for distribution to poorer communities.
As recently as a month ago, Emergent declined to offer any details on its pricing of OTC Narcan. And it has not yet responded to a request for comment from Gizmodo. Meanwhile, in his statement, FDA Commissioner Califf went on to say that the agency will “encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Other OTC naloxone products could soon become available to the public. The nonprofit pharmaceutical company Harm Reduction Therapeutics has also applied for approval of their OTC naloxone nasal spray called RiVive, which was granted priority review by the FDA last December. Should their drug be approved, the company expects to launch RiVive by early 2024. The company has also said that its primary mission is to provide free or low-cost naloxone to everyone.
Source: Gizmodo