Another overdose reversal drug reaches the market

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May 23, 2023 View in browser   By Katherine Ellen Foley and David Lim Presented by Driving the day Opvee, granted FDA approval on Monday, has been shown to reverse overdoses from fentanyl. | Courtesy of Indivior OVERDOSE REMEDY CLEARED FOR SYNTHETIC OPIOIDS — On Monday, the FDA approved Opvee, the first nasal spray cleared for overdose reversals of potent synthetic opioids like fentanyl. Opvee, manufactured by the drugmaker Indivior, is an inhaled version of nalmefene, a drug approved nearly 30 years ago in injectable and oral forms to reverse opioid overdoses. It is regularly used in hospitals to reverse the effect of powerful opioids used in surgical settings and, in some parts of the world, to treat alcohol use disorder. An opioid antagonist, it works similarly to naloxone. Narcan, a nasal spray form of naloxone, was recently approved for over-the-counter sale. Indivior says Opvee has demonstrated durability, which means it can reverse overdoses from drugs like fentanyl that remain in the body longer. According to recent CDC estimates, fentanyl killed more than 72,000 people last year out of nearly 80,000 who died of an opioid overdose. “It will be most effective in situations where EMS can’t respond quickly,” Jerome Adams, a former U.S. surgeon general, told Prescription Pulse. Opvee will require a prescription, although states that have permit waivers to distribute approved opioid antagonists can offer the drug from some pharmacists or “safe drug use” services, such as needle exchange programs — often for free. Indivior hasn’t said how much Opvee will cost, which could partly determine whether insurance plans will pay for it. Still, some experts fear the approval didn’t come soon enough: “In some ways, it feels like this drug is many years too late, and the drug supply has moved on,” said Nabarun Dasgupta, an innovation fellow at UNC Chapel Hill University’s public health school. Opvee has not yet been studied to determine whether it can combat overdoses for drugs containing xylazine, a powerful and dangerous-for-humans animal tranquilizer known as Tranq, which is frequently mixed with fentanyl. The Biden administration has declared the drug combination an emerging threat. Dasgupta also fears that many people who use drugs will be wary of Opvee’s side effects: Naloxone and nalmefene cause users to go through near-instant withdrawal. But because Opvee is more potent than naloxone, withdrawal symptoms of aches and pains, tremors, nausea, diarrhea and anxiety will last longer. IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Ireland has become the first country to require cancer warnings to accompany alcoholic beverages, starting in 2026. Do you think the U.S. will follow suit? Send news, tips and mocktail recipes to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Megan Messerly talks with Ben Leonard, who reports on the decision by private insurers working for Medicare to maintain coverage for remote monitoring devices that track patients’ vital signs at home — and explains why it’s a big win for the telehealth industry, which grew exponentially during the Covid public health emergency but now has to sell its services in a post-pandemic world. Listen to today’s Pulse Check podcast   A message from Express Scripts by Evernorth: 60 million Americans live in rural areas. Yet less than 10 percent of physicians practice in those parts of the country. That’s half the number of physicians needed to provide essential care to those communities. Express Scripts by Evernorth is expanding health care access for rural communities by advocating for more pharmacy services and reimbursement opportunities. Making health care more accessible for all. Learn more.   Eye on the FDA FDA Commissioner Robert Califf is slated to partake in a panel discussion at the Reagan-Udall Foundation on Wednesday. | Andrew Harnik/AP Photo CALIFF TO SPEAK AT FDA FOUNDATION MEETING — The Reagan-Udall Foundation, a nonprofit tasked with helping the FDA advance its mission, will hold its annual board of directors meeting Wednesday to lay out priorities for the year ahead. The meeting, open to the public, will include a panel discussion from FDA Commissioner Robert Califf, as well as the agency’s chief scientist, chief medical officer, chief of staff and chief counsel. What we’re watching: Your host will be listening for discussion of further changes to the FDA’s tobacco regulation after a foundation panel of experts recommended major changes in December for the agency’s Center for Tobacco Products. I’ll also be keeping an ear out for any talk of improving the accelerated approval pathway and how the agency plans to regulate Covid-19 boosters in the post-public health emergency era.   GET READY FOR GLOBAL TECH DAY: Join POLITICO Live as we launch our first Global Tech Day alongside London Tech Week on Thursday, June 15. Register now for continuing updates and to be a part of this momentous and program-packed day! From the blockchain, to AI, and autonomous vehicles, technology is changing how power is exercised around the world, so who will write the rules? REGISTER HERE.     Tobacco CTP’S FIRST HEALTH EQUITY ADVISER  — The FDA’s Center for Tobacco Products said Monday it has brought in Charlene Le Fauve, a behavioral scientist and addiction researcher, to be the senior adviser for health equity. La Fauve’s role will be within the FDA’s Office of the Center Director. She previously worked at the National Institutes of Health as a senior adviser to the chief officer for scientific workforce diversity. CTP Director Brian King reiterated his commitment to health equity last week at the E-Cigarette Summit in Washington. The FDA is slated to finalize a rule later this year that would ban menthol cigarettes, which are disproportionately used by Black smokers. MEDICAL DEVICES END OF COVID REQUIREMENTS HURTS PATIENTS — Top FDA medical device officials warned Monday that the expiration of a Covid-era requirement for medical device companies to report potential shortages presents a risk for consumers. Patients will be forced to navigate unexpected shortages until the agency comes up with regulations to require device shortage reporting. Congress required manufacturers to report certain device shortages during a public health emergency — data the FDA said was used in 2021 to warn the public and make plans for emergency manufacture of a shortage of devices that used resins. Suzanne Schwartz, director of the FDA’s Office of Strategic Partnerships and Technology Innovation, and Tammy Beckham, associate director of its Resilient Supply Chain and Shortages Prevention Program, are asking Congress to require firms to notify the agency of shortages and put risk management plans in place. “The agency should not have to learn of critical device shortages from desperate clinicians and patients,” Schwartz and Beckham wrote in Health Affairs. “By then it may very well be too late. By then too many vulnerable individuals will have already suffered the consequences of such shortages.”   A message from Express Scripts by Evernorth:   In the Courts GOVERNMENT LOSES CLINICAL TRIAL CASES — Last week, a federal jury in Miami acquitted executives accused of running fake clinical trials. In 2021, a grand jury indicted Tellus Clinical Research executives on charges of running a scheme to falsify clinical trial data. Prosecutors alleged researchers had collected thousands of dollars from drugmakers while falsifying records to enroll patients in trials for which they were not eligible and creating false data showing participants received interventions for opioid dependency, irritable bowel syndrome and kidney disease, the Miami Herald reported. Several people involved in Tellus Clinical Research previously pleaded guilty for their involvement in the scheme. But at last week’s trial, only physician Martin Valdes was found guilty of lying to the FDA. Valdes told the agency he evaluated patients involved in the trials when he did not.   DON’T MISS POLITICO’S HEALTH CARE SUMMIT: The Covid-19 pandemic helped spur innovation in health care, from the wide adoption of telemedicine, health apps and online pharmacies to mRNA vaccines. But what will the next health care innovations look like? Join POLITICO on Wednesday June 7 for our Health Care Summit to explore how tech and innovation are transforming care and the challenges ahead for access and delivery in the United States. REGISTER NOW.     Pharma Moves Erica Jefferson departed her role as the FDA’s associate commissioner for External Affairs on Friday. Heidi Rebello, who served as the Office of External Affairs’ deputy associate commissioner, will replace Jefferson. Quick Hits For KFF Health News, Lauren Sausser reports on the striking gap in the death rates of Black and white babies. The consolidation of nursing homes in Maine has spurred a rise in nonmedical residences for older adults — and many are incapable of handling residents’ complex needs, Rose Lundy writes for the Maine Monitor.   A message from Express Scripts by Evernorth: Express Scripts by Evernorth believes America’s rural communities, and independent pharmacies, deserve better. That’s why we’re leading the way with new ways to close gaps in care through partnerships with independent pharmacies across the U.S. We’re establishing the industry’s first Independent Pharmacy Advisory Committee to help pharmacies everywhere better support underserved communities. We’re making it easier to offer much-needed services like vaccinations, lifestyle counseling, and behavioral health screenings. And we’re increasing reimbursements paid to rural pharmacies for the essential services they provide today and well into the future. We invite all our partners and our competitors to follow our lead. And help improve the quality of care for all. Learn more.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley   Follow us

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