More than four months after the Food and Drug Administration approved the overdose reversal drug Opvee, manufacturer Indivior has begun shipping the life-saving drug to first responders and pharmacies.
Opvee, the nasal spray version of the drug nalmefene, works by blocking opioid receptors in the brain to quickly reverse the effects of an overdose. Rescue medication is approved for people 12 years of age and older and requires a prescription.
The antidote comes in a crowded market for overdose reversal drugs. Narcan, a nasal spray version of naloxone, is purchased and stocked by public health departments, schools, police, fire departments and federal agencies nationwide. And last month, retail chains CVS, Walgreens, Rite Aid, Walmart and others began selling Narcan without a prescription.
The nonprofit Harm Reduction Therapeutics will soon make its FDA-approved version of naloxone nasal spray, RiVive, available to community groups working to prevent overdoses. The group is partnering with Remedy Alliance, an organization that delivers inexpensive injectable naloxone to organizations working with high-risk populations.
Company touts ‘fentanyl fighter’
Amid controversy over its role in preventing overdoses, Indivior is aiming to convince public health agencies and consumers that Opvee is a better match to combat illicit fentanyl because of its effectiveness. Its potent formulation lasts longer than Narcan or other forms of naloxone.
Last year, illicit fentanyl and other synthetic opioids were involved in more than two-thirds of the 107,081 overdose deaths nationwide, according to the Centers for Disease Control and Prevention.
Former Surgeon General Jerome Adams called Opvee a “fentanyl warrior” and another tool for public health officials to combat the illegal fentanyl that causes overdose deaths nationwide.
“It’s as if it was designed to combat fentanyl,” Adams said. It closely matches the potency and longevity of fentanyl, so this is a valuable new tool available.
According to Adams, Opvee’s potency makes it stand out from the pack.
Adams said people who overdose on fentanyl may need several doses of naloxone to recover. This reality prompted federal researchers to take up the matter with pharmaceutical companies.
Agencies within the U.S. Department of Health and Human Services have awarded grants worth $10.8 million and $7.4 million for research supporting the development of Opvee.
Mark Crossley, CEO of Indivior, believes that Opvee’s longer-acting formulation better targets the illicit fentanyl circulating in the nation’s drug supply than other drugs in the drug market. The number of overdose rescue medications is increasing.
Opvee gives gifts to create interest
Indivior is trying to attract interest from government buyers by offering free doses to state and local agencies that employ emergency medical workers. Once these first responders “have enough experience (deploying Opvee), we think that will be part of their purchasing decision,” Crossley said.
The company also wants to add retail offerings through pharmacies and increase public awareness of the life-saving drug. The company will also support policy changes such as standing orders allowing pharmacists to dispense drugs without a prescription.
Currently, 11 states have standing orders to facilitate easier access to nalmefene, a company spokesperson said. All 50 states have such standing orders for naloxone.
“Unlike day one, the product is in all of these pharmacies and ready to go,” Crossley said. “It’s early days of launch. We’re still building those capabilities.”
Affordability concerns persist
Even with more options for overdose-reversing drugs, some community groups worry that those who need the kits most may not have affordable access.
Opvee will cost $75 per kit for government or general public buyers and $98 for others without insurance. Private health insurers don’t yet cover the newly launched drug, but company officials expect many consumers will end up paying little or nothing once the companies Insurance covers the antidote.
The retail price of naloxone has become more affordable in recent years. A 2018 Senate subcommittee said that as awareness of the risks of overdose from prescription drugs and heroin use emerged in the mid-2010s, a small company in Virginia priced its injectable naloxone at up to 4,100 USD for one dose.
Narcan launched in 2015 and quickly became the dominant product. It was originally priced at $125 for a two-dose kit, although the company has been selling the kit for $75 to emergency medical teams and government agencies. Retailers currently charge $44.99 for a two-dose kit purchased over the counter.
Harm Reduction Therapeutics will charge $36 per kit for the naloxone spray version. The group’s partner, Remedy Alliance, distributes a less expensive naloxone injection that has been available for decades.
Sarah Evans, director of drug policy at the Open Society Foundations, which promotes human rights and economic, legal and social reform, said new suppliers are responding to public demand for Overdose reversal drugs to combat the availability of cheap fentanyl.
“There seems to be a rush to market from a number of different companies with different formulations and different delivery mechanisms,” Evans said. The problem we have in America is really a distribution problem to get enough of that product out into the community and into the hands of people who need it.
Evans said the least expensive form of the overdose drug is the oldest injectable drug naloxone, which has been around for decades.
Maya Doe Simkins, co-director of Remedy Alliance, said Remedy Alliance’s pricing was “cheap, cheaper and free” for the 1.6 million doses of naloxone injections delivered in the past year.
Opioid rescue medications carry the risk of withdrawal
Critics say the longer-acting nalmefene spray on the market may have limitations. Some experts warn that stronger versions of the drug can cause unpleasant side effects for fentanyl users.
The FDA says opioid addiction patients who use nalmefene may experience withdrawal symptoms such as body aches, diarrhea, nausea, vomiting and stomach cramps.
While injectable naloxone or Narcan can cause withdrawal symptoms that quickly pass, opioid users worry the symptoms could linger for those using long-term overdose reversal drugs, Evans said. longer.
“Withdrawal is real, it is painful and can even be life-threatening,” Evans says. Fear of such symptoms may keep some people from carrying stronger anti-overdose medications “because they would rather risk an overdose than face the pain of withdrawal.”
Others believe that drug users will adapt when they learn about the effects of the new drug. If Opvee were more widely distributed among high-risk populations, users would “have a better sense of how stronger it is, how long it lasts, and how you can get away with fewer doses.” more quality,” Adams said.
Ken Alltucker is on X, formerly Twitter, at@kalltucker, or can be emailed at email@example.com.
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