A new 'fentanyl fighter' hits a market crowded with overdose reversal drugs

More than four months after the Food and Drug Administration approved the overdose reversal medication Opvee, the manufacturer, Indivior, has started shipping the life-saving drug to first responders and pharmacies.

Opvee, a nasal spray version of the drug nalmefene, works by blocking opioid receptors in the brain to quickly reverse the effects of an overdose. The rescue medication is approved for people 12 and older and requires a prescription.

The antidote arrives in a crowded market of overdose reversal drugs. Narcan, a nasal spray version of naloxone, is purchased and stocked by public health departments, schools, police and fire departments and federal agencies nationwide. And last month, chain retailers CVS, Walgreens, Rite Aid, Walmart and others began selling Narcan over the counter without a prescription.

The nonprofit Harm Reduction Therapeutics will soon make its FDA-approved nasal spray version of naloxone, RiVive, available to community groups working to prevent overdoses. The group is partnering with Remedy Alliance, an organization that ships inexpensive injectable naloxone to organizations that work with high-risk populations.

Company touts 'fentanyl fighter'

Amid the wrangling for a 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 its powerful formulation lasts longer than Narcan or other forms of naloxone.

Last year, illicit fentanyl and other synthetic opioids were linked to more than two thirds of the nation's 107,081 drug overdose deaths, according to the Centers for Disease Control and Prevention.

Former Surgeon General Jerome Adams called Opvee a "fentanyl fighter" and another tool for public health officials to counter illicit fentanyl driving the nation's overdose deaths.

“It’s as if it was designed to combat fentanyl,” Adams said. “It matches up well with the potency and the longevity of fentanyl, so it's a new valuable tool that is available.”

Opvee's potency makes it stand out from the pack, according to Adams.

People who overdose on fentanyl may need several doses of naloxone to recover, Adams said. This reality prompted federal researchers to tackle the problem with drug companies.

Agencies within the U.S. Department of Health and Human Services issued grants of $10.8 million and $7.4 million on research that supported the development of Opvee.

Mark Crossley, CEO of Indivior, believes Opvee's longer-acting formula better targets illicit fentanyl circulating in the nation's drug supply than others among the growing number of overdose rescue drugs.

Opvee giveaway to generate interest

Indivior is attempting to generate interest among government purchasers by offering free doses to state and local agencies that employ emergency medical personnel. When these first responders "get enough experience (deploying Opvee), we think it will be part of their purchasing decision," Crossley said.

The company also wants to add retail offerings through pharmacies and build public awareness about the rescue medication. The company will also advocate for policy changes such as standing orders that allow pharmacists to dispense the medication without a prescription.

Now, 11 states have standing orders that ease access to nalmefene, a company spokesperson said. All 50 states have such standing orders for naloxone.

"It's not like on day one, the product is in all of these pharmacies and ready to go," Crossley said. "It's in the early days of launch. We're still building up those sorts of capabilities."

Affordability concerns persist

Even with a wider selection of overdose reversal drugs, some community groups worry those who need the kits the most might not get affordable access.

Opvee will cost $75 per kit for government or public interest purchasers, and $98 for others with no insurance coverage. Private health insurers don't cover yet the just-launched drug, but company officials expect many consumers will eventually pay little to nothing once insurers cover the antidote.

The retail price of naloxone has become more affordable in recent years. When awareness about the overdose risk from prescription pills and heroin use surfaced in the mid-2010s, one small Virginia company priced its injectable naloxone as much as $4,100 for a dose, a 2018 Senate subcommittee found.

Narcan launched in 2015 and quickly became a dominant product. It initially cost $125 for a two-dose kit, though the company sold the kit for $75 to emergency medical crews and government agencies. Retailers now charge $44.99 for a two-dose kit purchased over the counter.

Harm Reduction Therapeutics will charge $36 per kit for a spray version of naloxone. The group's partner, Remedy Alliance, distributes a less expensive injectable naloxone that’s been available for decades.

New suppliers are responding to the public demand for overdose reversal drugs to counter the availability of cheap fentanyl, said Sarah Evans, division director of drug policy at Open Society Foundations, which promotes human rights and economic, legal and social reform.

“There seems to be a rush to market from a number a number of different companies with different formulations and different delivery mechanisms,” Evans said. “The problem we have had in the U.S. really is a problem of distribution – getting enough of that product out into the community and into the right hands.”

Evans said the least expensive form of the overdose drug is the oldest – injectable naloxone that’s been around for decades.

Remedy Alliance's pricing was "cheap, cheaper and free" for 1.6 million injectable naloxone doses delivered the past year, said Maya Doe Simkins, co-director of Remedy Alliance.

Opioid rescue drugs carry withdrawal risk

Critics say the longer-lasting nalmefene spray on the market may have drawbacks. Some experts warn that more powerful versions of the drug can carry unpleasant side effects for fentanyl users.

The FDA said opioid-addicted patients who use nalmefene may experience withdrawal symptoms such as body aches, diarrhea, nausea, vomiting and stomach cramps.

While injectable naloxone or Narcan can trigger withdrawal symptoms that quickly pass, opioid users worry symptoms might linger for people who use longer-lasting overdose reversal drugs, Evans said.

"Withdrawal is real, it's painful and it can even be life threatening," Evans said. The fear of such symptoms might prompt some to not carry the more powerful overdose reversal drugs "because they'd rather have the risk of overdose than face the pain of withdrawal."

Others believe drug users will adapt when they learn about the potency of the new dugs. If Opvee is distributed more widely among at-risk populations, users will "get a better feel for how much more potent it is, how much more long lasting it is and how you can get away with fewer doses," Adams said.

Ken Alltucker is on X, formerly Twitter, at @kalltucker, or can be emailed at alltuck@usatoday.com.

This article originally appeared on USA TODAY: 'Fentanyl fighter': Opvee opioid overdose reversal drug lasts longer