A tale of two opioid antidotes

Aug 09, 2024

Driving the day

A naloxone kit is pictured.

The FDA approved on Aug. 7 an alternate opioid overdose reversal injection to naloxone, pictured here. | Andrew Burton/Getty Images

NEW OVERDOSE REVERSAL MED — The FDA this week approved a new product to reverse opioid overdoses, but some harm-reduction experts say it’s an unnecessary tool that could pose more risks than benefits.

The FDA late Wednesday approved Zurnai, an autoinjector made with nalmefene, which is a longer-acting chemical cousin of the gold-standard reversal-drug naloxone. The drug is available by prescription only and is indicated for people age 12 and older suspected or known to be suffering an opioid overdose.

"The FDA remains focused on broadening access to opioid overdose reversal agents, including naloxone and nalmefene,” Commissioner Robert Califf said in a statement.

Others urge caution: But Mike Selick, associate director of capacity building at the National Harm Reduction Coalition, said there’s no need for Zurnai because naloxone is proven effective at reversing overdoses caused by heroin, fentanyl and its analogs. The best response to a known or suspected overdose, he added, is to use the lower dose of naloxone with rescue breathing.

“Higher dose reversal drugs and long acting reversal drugs put people who are dependent on opioids into longer and more severe withdrawal,” he told Prescription Pulse in an email. “This makes people less likely to seek further care and more likely to try and use more opioids which can result in another overdose.”

Background: Selick’s position mirrors a statement issued last year by the American College of Medical Toxicology and the American Academy of Clinical Toxicology, months after the FDA approved a nalmefene-based nasal spray.

Even then, nalmefene wasn’t a new drug — the FDA approved it in 1995 as an injectable opioid antidote. The manufacturer pulled it from the market in 2008 for commercial reasons.

“The longer duration of action of nalmefene does not eliminate the need for medical observation after administration,” the two groups said in the statement. “We are concerned that the long duration of action may provide a false sense of comfort that no further care is needed.”

If a patient receives nalmefene in an emergency room, they said, the drug’s administration could spur a longer stay, thus stressing resources.

Another wrinkle: Zurnai is made by a well-known name in the opioid space: Purdue Pharma. The company, which is blamed for fueling the rise of the opioid epidemic by pushing addictive painkiller prescriptions, said in a statement it’s “working to provide Zurnai at no profit to the Company.”

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Your host hopes D.C.-area native Noah Lyles recovers from Covid soon (and notes that she would not be winning any Olympic medals if she were scheduled to race while sick).

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Drug Pricing

JUDGE DISMISSES CHAMBER IRA CASE — District Court Judge Michael J. Newman rejected the U.S. Chamber of Commerce’s challenge to Medicare drug price negotiations on Thursday, taking issue with what he termed the group’s attempt to venue shop for a favorable opinion.

Newman, who was appointed by former President Donald Trump, determined that the three other groups party to the chamber’s lawsuit — all state or local chambers representing Michigan and Ohio — didn’t have standing to bring the case before the Ohio Southern District. He found the U.S. Chamber “may plausibly have standing” but that his court was the wrong venue.

Sharp words: Newman addressed one of the biggest critiques leveled against the pharma industry allies that have sued over the program in courts nationwide — that they’re angling for favorable rulings in historically conservative jurisdictions to split from anticipated dismissals in other courts hoping to elevate their cause to the Supreme Court.

“If the Court found the Dayton Area Chamber of Commerce had standing in this case, it would open the door for any individual or company to bypass venue rules by becoming a member of any association remotely related to a challenged law or regulation,” Newman wrote. “The Court will not adopt a loose interpretation of the standing requirement for the purpose of forum shopping.”

Next steps: A chamber spokesperson said the group is weighing its next move as it reviews the decision. It’s the seventh case to be rejected at the district court level; two lawsuits — Merck’s and Novartis’ — are awaiting decisions.

Industry Intel

David Ricks speaks.

Eli Lilly CEO David Ricks speaks at the Economic Club of New York on March 12, 2024, in New York. The U.S. drugmaker, which makes popular drugs for weight loss and diabetes, saw a 36 percent revenue increase in the second quarter of 2024 compared with the same time last year, in part due to those medications. | Spencer Platt/Getty Images

GLP-1s BOOST LILLY EARNINGS — Eli Lilly posted a 36 percent revenue jump in the second quarter of 2024 compared with the same time last year, the company said Thursday, a jump it attributed in part to GLP-1 diabetes and weight-loss brands Mounjaro and Zepbound.

Production increases for those drugs helped promote sales growth, Lilly said, but it still anticipates “periodic supply tightness” for certain dosages as demand increases. While all dosages of the two drugs were considered available in the U.S. as of Aug. 2, the FDA hasn’t removed them from its drug shortage list as it evaluates various market dynamics to determine whether back orders can be filled and the company can consistently meet demand.

CEO Dave Ricks said the production increase will translate to patients likely having to wait a few days to get their prescriptions filled but suggested that doesn’t mean the drugs are still in shortage.

“We're doing well, given the situation, but the end pharmacy experience will continue to be choppy. We point that out to the FDA,” he said. “So that means people may call and say, ‘I couldn't get what I wanted the moment I wanted it at the pharmacy I choose to [use].’ That's not the definition that we think applies here. So we'll continue to work with channel partners and the agency to try to clear up the confusion and improve the consumer experience, which is our responsibility along with theirs.”

Compounding concerns: Executives said Lilly’s primary concern with compounding pharmacies trying to meet demand is patient safety rather than lost market share. Compounding groups have argued that products made by legitimate pharmacies are subject to rigorous standards.

Ricks attributed GLP-1 shortages to industry manufacturing constraints around sterile injectable drugs and indicated the company will continue its political and legal advocacy targeting compounders.

AROUND THE AGENCIES

MEDICARE DEVICE PATHWAY — CMS finalized a long-awaited rule Wednesday creating a pathway for Medicare to cover some FDA-designated breakthrough medical devices after the White House rescinded a Trump-era regulation, Chelsea and Ben report.

Industry reaction to the rule was mixed, with some groups saying it didn’t go far enough by excluding diagnostics and limiting eligibility to five devices per year.

Pharma Moves

Dr. Amanda Banks will be chief development officer at Ovid Therapeutics, a biotech company focused on treatments for rare epilepsies and brain conditions. She previously co-founded and was the CEO of Blackfynn, a data platform company developing neurological disease therapies.

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WHAT WE'RE READING

HHS has yet to finalize guidelines for its employees at public health agencies like the CDC and the FDA to report political interference two years after a government watchdog recommended them, POLITICO’s Sophie Gardner reports.

Drugmakers and their allies are ramping up lawsuits challenging state laws forbidding them from limiting supply of discounted drugs to certain pharmacies under the 340B safety-net program for lower-income patients, Bloomberg Law writes.

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