番茄社区

Adapt Pharma's naloxone nasal spray (Narcan) has been working well in the real world, reversing the vast majority of opioid overdoses for which it's deployed, researchers reported here.

In a survey of a small number of community organizations that used the 4-mg nasal spray, first responders were successful at reviving about 98% of cases who went on to survive, , senior medical advisor to Delaware County in Pennsylvania, and colleagues reported at the .

Withdrawal syndrome -- originally raised as a concern with the 4-mg dose -- occurred in 14.3% of cases, which was deemed acceptable, Avetian said.

"I think this shows the safety of the product," Avetian told 番茄社区. "We're seeing much stronger [drugs] hit the streets. I feel more comfortable giving a 4-mg dose than a 2-mg dose. I'd rather deal with [withdrawal] than go to the coroner."

Community groups have been eager for real-world data, as only pharmacokinetic and usability data were needed for FDA approval of Adapt's product. The company conducted the survey ahead of an October FDA advisory committee that was tasked with examining whether naloxone dosing standards needed to be raised. (The panel was divided.)

A request to participate in the survey was sent to 152 of the 216 community organizations in the U.S. to which Adapt had distributed its Narcan nasal spray. The groups included law enforcement, county government, health departments, emergency medical services, advocacy groups, community outreach and harm reduction groups, volunteers, shelters, and pharmacy service centers.

Only eight of those groups provided information -- but sources contacted by 番茄社区 who were not involved in this survey said these groups probably didn't keep adequate data to provide meaningful information. Avetian noted that his county collected standardized information as soon as they began providing Narcan to stakeholders in the community, but acknowledged that not all groups took the same initiative.

All told, those groups had information on 261 attempted opioid overdose reversals using Narcan nasal spray.

Of the 245 cases in which outcomes were reported, 242 were successfully revived, the researchers said. Two of the three deaths were in cases for which Narcan was administered after the period in which naloxone would be considered effective. Details weren't provided for the third fatal case.

Most cases of opioid overdose (97.6%) were reversed with one or two doses, the researchers found. And response came quickly: of the 170 cases for which time to response was reported, 73.5% recovered consciousness in less than 5 minutes after administration.

Heroin was the most common opioid involved in overdose, reported in 95.4% of cases. Fentanyl was presumed to be involved in overdose in 5.2% of cases, they found. More than a third of cases had some indication that the patient had used multiple substances.

The study was limited by its retrospective nature and reliance on unconfirmed reports from the organizations surveyed. Also, the low response rate could indicate response bias, the researchers warned.

Still, they concluded that the results suggest 4-mg Narcan nasal spray is effective at reversing the effects of an opioid overdose, and that response time is consistent with what's reported for intramuscular naloxone formulations.

"As Delaware County's senior medical advisor, I'm going to stick with the 4-mg dose," Avetian told 番茄社区. "I'm comfortable with it, our partners in law enforcement are happy with it since it's easy to use, and the results suggest it's very effective."

The FDA approved Adapt's 2-mg dose of Narcan nasal spray in January. Experts told 番茄社区 a lower dose may be effective in areas that don't have as big of a problem with more potent synthetic opioids like fentanyl and, increasingly, the particularly dangerous veterinary sedative carfentanil.

The 2-mg formulation of Narcan made by Adapt has not yet launched. The FDA recently , which also makes a 0.4-mg injectable form and a 1-mg version that's easily adapted for off-label intranasal use.

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