ALBANY — A new entrant in the fight against opioid overdoses is lobbying for state approval for wider distribution, with advocates saying its quick-acting drug could be used to combat fentanyl overdoses. It claims to be designed for ingestion.
A “continuing order” from the state now allows only first responders and certified medical professionals to obtain Narcan at a discounted price under state funding, without having to obtain a separate prescription. has been done. Supporters of a new overdose suppressant made under the brand name Opvee hope to be added to that mandate.
But the state says the new option hasn’t been tested enough to promote widespread use under the state order. Opvee is available through private prescriptions in the state. His Opvee, a nalmefene nasal spray, is also more expensive than Narcan.
So-called opioid antagonists combat overdoses of drugs such as codeine and oxycodone, which are prescribed to relieve pain but are highly addictive.
What you need to know
- Manufacturer of Opvee, newcomer It is lobbying for state approval for wider distribution in the fight against opioid overdoses.
- Current “continuation order” from the state Only first responders and certified medical professionals will be able to obtain Narcan at a discounted price under state subsidies without having to obtain a separate prescription. The makers of Opvee want to add to that order.
- But the state says no new options have been introduced. There has still been enough testing to encourage widespread use under state mandates.
OpVee was approved by the federal Food and Drug Administration last May, 10 months after the agency placed a standing order for Narcan, the brand name for a device that delivers naloxone. The FDA currently recommends OpVie in conjunction with Narcan to combat opioid overdoses.
New options work faster
Opvee’s maker, Indivior Inc., claims the product works faster and is better suited to attack the surge in opioid overdoses caused by cheap and deadly synthetic opioids such as fentanyl. .
OpVe can revive someone who has overdosed in just five minutes, compared to Narcan’s 20 minutes, said Judy Dane, a spokeswoman for Indivior and OpVe.
“The speed of action of reversal agents is an important consideration, given that synthetic opioids such as fentanyl act rapidly and can cause respiratory depression and death,” Dane said.
Some recent studies have shown that Opvee can fight overdoses involving fentanyl faster than Narcan. For example, the Journal of Clinical Pharmacology noted in March that “this rapid onset of action could prove particularly valuable in an era when more than 90% of deaths are associated with synthetic opioid overdoses. There is,” the report said.
Opvee’s first on-site testing took place in Oakland County, Michigan. So the sheriff was looking for a better way to reverse opioid overdoses, which are increasingly caused by the more powerful fentanyl.
“We’re seeing more and more overdoses where multiple doses of Narcan have no effect,” said Sheriff Michael Bouchard. “We’re seeing more and more powerful fentanyl, and Opvee is the only FDA-approved drug for synthetic fentanyl. . . . You need to have the tools in your toolbox to handle fentanyl.”
New York limited sale
Emergent BioSolutions, the maker of Narcan, has received $66 million in exclusive state contracts to provide the product to state and local governments since 2017, according to New York state records. Over the years, Narcan has become deeply involved in state opioid overdose prevention programs, and the drug it uses, naloxone, is frequently mentioned in state law.
In Nassau, Narcan kits will be installed at county courthouses and parks starting in 2023. In Suffolk County, Narcan kits have been installed in county courthouses since 2020.
According to New York State’s 2023 Annual Opioid Report, opioid deaths in New York state are caused by synthetic opioids, primarily fentanyl. Between 2015 and 2021, synthetic-related opioid deaths increased by 587.7%, resulting in 4,595 deaths statewide in 2021, according to the report.
Initial field testing of Opvee is underway in New York state.
In April, Broome County Sheriff Frederick Akshar began equipping road patrol and correctional officers with OpVie in addition to Narcan. His decision came after he said Narcan requires multiple doses almost every time it is used.
This observation is supported by the state’s 2023 Annual Opioid Report, which states: [fentanyl] Multiple doses of naloxone, a drug that can reverse the effects of an opioid overdose, are often required. ”
action in albany
Albany’s bill would require the state to accept all FDA-approved recovery drugs to create a “comprehensive toolkit to effectively combat the overdose crisis.”
The bill’s sponsor, Sen. Pete Harkum (D-South Salem), an addiction survivor, has long supported the use of Narcan but now makes OpVy part of the state’s arsenal against opioid overdoses. We are promoting its introduction.
“We are in the midst of the worst overdose crisis our country has ever seen, and the numbers continue to rise,” Harkum said. “We’re not telling people what they have to use . . . but we need every tool in the toolkit to save lives.”
However, the state health department remains committed to using Narcan instead of Opvee, in part because Opvee does not yet have a proven track record in this area.
“Based on current science and clinical judgment, we believe the products available under the continuing order are the appropriate formulation to keep New Yorkers safe,” Department of Health spokeswoman Cadence Acquaviva said of Narcan. ” he said.
She said OpVee is approved by the federal government but not under state health law. This means that Opvee cannot be added to standing orders or used in pilot programs without legislative or administrative action.
Acquaviva said that opioid-intoxicated overdose patients face nearly 11 hours of withdrawal with OpVie’s drug, compared to 1 to 2 hours with Narcan, and that “emergency rooms and health care workers are “This poses an undue burden on the public,” he said.
The price is also a concern. Opvee can be twice as expensive as Narcan, which often sells for $44.99 per dose. However, studies have shown that OpVee requires fewer doses than Narcan, which can alleviate higher costs.
The company that makes Narcan points out that it conducts extensive research and field testing for its brand.
“We have amassed nearly a decade’s worth of real-world evidence that naloxone can be safely used as a first-line opioid overdose reversal antidote,” said an Emergent and Narcan spokesperson. said Asal Helmer. “Today, naloxone remains a valid option in the current situation.”
In comparison, OpVee “has a longer half-life than naloxone, which means it can stay in your body longer,” Helmer said. “This can make withdrawal symptoms more severe and prolonged.”
State health departments are not alone in their reluctance to adopt Opvee.
“These data suggest that stronger, longer-acting drugs may not be necessary and their presence may cause unwarranted harm, such as more severe or prolonged withdrawal symptoms. This confirms the idea,” said a February report by a nonprofit group of researchers and universities from around the world. They are called open researchers and contributors. The group called for more research to be done before Opvee is widely used.
