Science
FDA Approves Journavx Drug to Treat Pain Without Addiction Risk
The Food and Drug Administration approved a new medication Thursday to treat pain from an injury or surgery. It is expensive, with a list price of $15.50 per pill. But unlike opioid pain medicines, it cannot become addictive.
That is because the drug, suzetrigine, made by Vertex Pharmaceuticals and to be sold as Journavx, works only on nerves outside the brain, blocking pain signals. It cannot get into the brain.
Researchers say they expect it to be the first of a new generation of more powerful nonaddictive drugs to relieve pain.
To test the drug, Vertex, which is based in Boston, conducted two large clinical trials, each with approximately 1,000 patients who had pain from surgery. They were randomly assigned to get a placebo; to get the opioid sold as Vicodin, a widely used combination pain medicine of acetaminophen (Tylenol) and hydrocodone; or to get suzetrigine.
In one trial, patients had an abdominoplasty, or tummy tuck. In the other, they had a bunionectomy. Side effects of suzetrigine reported by patients were similar to the ones reported by those taking the placebo.
The company also submitted data from a 250-person study that assessed the drug’s safety and tolerability in patients with pain from surgery, trauma or accidents.
Suzetrigine eased pain as much as the combination opioid. Both were better than the placebo at relieving pain.
Suzetrigine’s price, though, is much higher than that of acetaminophen plus hydrocodone. Patients are expected to take two pills a day, for a total cost of $31 a day. The older drug, said Dr. John D. Loeser, an emeritus pain expert at the University of Washington, is “dirt cheap” at pennies per pill.
But suzetrigine does not have opioids’ unpleasant side effects like nausea and drowsiness, and it is nonaddictive.
“There are a number of people who, once they have an opioid, want an opioid constantly,” Dr. Loeser said.
About 85,000 people a year become addicted after taking a prescription opioid, said Dr. David Altshuler, chief scientific officer at Vertex. It’s a small proportion of the 40 million prescribed opioids each year for acute pain — from surgery, accidents or trauma — but is nonetheless a large number, he said.
The story of suzetrigine began in the late 1990s with basic research by Dr. Stephen Waxman of Yale. He wondered how nerve cells signal pain to the brain.
Nerve cells have nine sodium channels — tiny molecular batteries — that generate electrical signals.
But, he discovered, two of those channels are only active outside the brain. One, called Nav1.7, is like the fuse for a firecracker, Dr. Waxman said. A nerve cell activates Nav1.7. That signal, in turn, activates a second channel, Nav1.8, which, he said, sends electrical signals of pain to the brain.
It seemed that a drug that could block Nav1.7 or Nav1.8 could be a potent pain medication that would have no effects on the brain, and therefore would not be addictive. (Dr. Waxman is not paid by Vertex, but does consult for other companies working on similar drugs.)
But there was another piece of the puzzle: Were these lab results applicable to humans?
If the lab work was predictive, people with mutations that made Nav1.7 or Nav1.8 fire constantly would be in constant pain. And people with the opposite mutation — one that blocked the channels — should feel no pain.
Both sorts of mutations would be extremely rare, if they existed.
Dr. Waxman contacted pain physicians across the entire Northern Hemisphere, asking if they had patients who had constant, intractable pain that could be caused by mutations that made Nav1.7 or Nav1.8 overactive. He came up empty-handed.
Then, in 2004, the Erythromelalgia Association told him about a family in Alabama whose members were wracked with pain. Most had ended up addicted to opioids and were unable to go to school or to work. Their condition was called “Man on Fire syndrome.”
Dr. Waxman and his colleagues found that the members of this family had a mutation in the Nav1.7 channel that made their pain nerves fire constantly.
Another group of researchers reported that a family in Pakistan whose members felt no pain had a mutation that blocked the same channel from firing. People called them firewalkers because they could walk on hot coals and feel nothing, which they did for money.
Vertex’s new drug, which blocks the Nav1.8 channel, is highly specific — the other sodium channels are left alone by the drug. Suzetrigine’s effects disappear when people stop taking the pills.
But although people with acute pain might need such a drug, there is also another group that needs pain relief but has few good options — those who have damaged nerves that cause constant pain, called peripheral neuropathic pain. That group includes people with diabetes, which can make the hands or feet hurt or go numb, among other symptoms. And it includes people with lumbosacral radiculopathy, or pinched nerves in the spine. Sciatica is one form of this condition.
In small studies, Vertex found that suzetrigine helped those with diabetic neuropathy, but was no better than placebo in those with pinched spinal nerves.
But, Dr. Altshuler said, the company is going ahead with larger studies in both groups of patients. While analysts and researchers deemed the results disappointing in patients with pinched nerves in their spines, the company decided to proceed because there are no approved drugs for the painful condition, and because the drug is safe and “the mechanism of action is so clearly validated.”
“No one has ever helped these four million people,” he said.
new video loaded: Pentagon Releases U.F.O. Files
By Jorge Mitssunaga
May 8, 2026
President Trump has signed off on a plan to fire Dr. Marty Makary, commissioner of the Food and Drug Administration, after a series of clashes over vaping, oversight of the abortion pill and a series of new drug application denials that rattled biotech companies, according to a person briefed on the matter, who was not authorized to discuss it publicly.
Dr. Makary had a high profile for an F.D.A. commissioner, appearing frequently on television and podcasts to sell the work he was doing at the agency on improving the food supply, speeding up some drug approvals and trying to restore agency morale after thousands of staff members left.
He tried to walk the tightrope between the business-friendly Make America Great Again movement, pledging to get rid of regulations that slow down innovation and to attract more drug trials to the United States. He was an ally of Health Secretary Robert F. Kennedy Jr.’s Make American Healthy Again supporters, voicing the skepticism of the pharmaceutical industry and authorizing natural food dyes.
Ultimately, Dr. Makary’s efforts were not enough to overcome the grievances of a growing band of enemies focused on selling tobacco, opposing abortion and seeing biotech therapies authorized.
Mr. Trump’s decision to dismiss him was first reported by The Wall Street Journal.
The decision could still change, given Mr. Trump’s propensity to change his mind Dr. Makary has also proven persuasive with Mr. Trump in beating back previous efforts to oust him.
Leaving the White House Friday evening, Mr. Trump dismissed the idea that Dr. Makary would be fired.
“I’ve been reading about it, but I know nothing about it,” he said.
The White House has pressured Dr. Makary for months to authorize flavored e-cigarettes, according to a person close to the conversations. The approvals were a top wish of major tobacco companies that have been top donors to Mr. Trump. In March, the F.D.A. issued a memo saying that it would only authorize e-cigarettes in flavors such as mint, tea and spices. The memo said the fruit and candy flavors would be unlikely to pass muster, given their appeal to young people.
Pressure continued, though, and on Tuesday the F.D.A. authorized blueberry and mango flavored e-cigarettes by Glas, a small company based in Los Angeles.
Abortion foes including Susan B. Anthony Pro-Life America have continued to turn up the heat on Dr. Makary, reiterating their call for his firing on Thursday. The group’s leaders and others view Dr. Makary as dragging his feet on a safety review of the abortion pill mifepristone, which they viewed as a way to highlight what they believe are dangers of the drug. Former Vice President Mike Pence, who also opposes abortion rights, amplified criticism of Dr. Makary on social media as well.
The administration has been under pressure from conservatives to tighten regulations on the prescribing and dispensing of mifepristone. The Supreme Court is reviewing a federal appeals court ruling that temporarily blocked abortion providers from prescribing the drug through telemedicine and sending it to patients by mail.
Biotech companies and their investors have also raised alarms with the White House about agency decisions to reject a series of treatments for rare diseases. The F.D.A. typically turns down about 20 percent of the applications it receives for drug approvals from companies.
Dr. Makary has been aggressive in defending the decisions, which he said came from career scientists who found the medications ineffective.
Dr. Makary also had to contend with a health secretary who seemed to view the F.D.A. as an avenue for getting his favored products authorized, exemplified by Mr. Kennedy’s social media post saying that the agency would end its “war on” stem cell treatments, peptides and raw milk. Mr. Kennedy pushed the F.D.A. to reverse a 2023 ban and allow the use of a number of peptides, unproven compounds purported to offer anti-aging or muscle-recovery benefits.
Before leading the F.D.A., Dr. Makary was a cancer surgeon and health policy researcher at Johns Hopkins University School of Medicine. He was also the author of several books about the health care system.
Some of Dr. Makary’s more popular moves included encouraging broader use of hormone replacement products for women and lifting the F.D.A.’s warnings on them. He helped speed some promising drugs to market, including a pancreatic cancer therapy and the pill form of the popular GLP-1 weight loss drugs.
Some California residents were among the 147 passengers and staff aboard a luxury cruise ship stricken by a suspected outbreak of hantavirus that has left three people dead and several others severely ill, officials confirmed Thursday.
California public health officials say they are monitoring the situation after being notified by the U.S. Centers for Disease Control and Prevention that some state residents were passengers on the MV Hondius. The precise status of those individuals, however, remains murky.
Hantavirus is a rare but deadly disease that attacks the lungs and is typically contracted by humans through inhalation of particles contaminated with the urine, feces or saliva of a wild rodent.
However, Dr. Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, confirmed Thursday that the Andes virus — a form of hantavirus that can spread from person to person — was involved in the outbreak.
Here’s what we know:
The MV Hondius cruise ship anchored at a port in Praia, Cape Verde, on Wednesday.
(Misper Apawu / Associated Press)
As its name suggests, the Andes virus is typically found in South America. The Dutch-flagged MV Hondius was on a 46-day journey that traveled from Antarctica with stops in Argentina.
In the case of human-to-human transmission, a person would first be infected by a wild rodent’s contaminated particles and then pass the infection to someone else, said Dr. Gaby Frank, director of the Johns Hopkins Special Pathogens Center.
“In previous outbreaks of Andes virus, transmission between people has been associated with close and prolonged contact, particularly among household members, intimate partners and people providing medical care,” Ghebreyesus said. “That appears to be the case in the current situation.”
None of the remaining passengers or crew members on the ship are symptomatic, he said.
The ship was not permitted to allow passengers to disembark at its original destination, Cape Verde, and is sailing for Spain’s Canary Islands.
“I want to be unequivocal here: This is not SARS-CoV-2. This is not the start of a COVID pandemic. This is an outbreak that we see on a ship. There’s a confined area,” Dr. Maria Van Kerkhove, who leads the WHO’s epidemic and pandemic management, said at a briefing. “This is not the same situation we were in six years ago. It doesn’t spread the same way like coronaviruses do.”
California passengers on the cruise
On April 1, 114 guests boarded the cruise ship in Ushuaia, Argentina. Twenty-three days later, 30 passengers — including six people from the United States — disembarked on a stop in St. Helena, a remote island about 1,100 miles off the coast of Africa, according to the cruise operator Oceanwide Expeditions.
Public health agencies in California, Georgia and Arizona were notified by the CDC that some of their residents were among the passengers on the cruise. It’s unclear whether these individuals disembarked on April 24, however.
The CDC is assisting local health authorities with monitoring California residents who were aboard the cruise, according to a statement by the California Department of Public Health on Friday.
As of Friday, one passenger has returned to their California residence and is in contact with local public health officials, and at least one other remains aboard the ship, according to the state agency.
“We understand that news of an unusual outbreak can be concerning,” said Dr. Erica Pan, director of the California Department of Public Health. “Unlike influenza and COVID-19, years of experience in South America have shown that this Andes hantavirus rarely spreads between people.”
Officials said the current public health protocol is to do daily symptom monitoring and reporting.
“As there are no known cases of Andes hantavirus infection from people without symptoms, and any spread has usually been limited to people with prolonged close contact with an ill person with this virus, the risk to the general public in California is extremely low,” the agency said in a statement.
In a statement earlier this week, the CDC also said that the risk to the American public “is extremely low” at this time.
“We urge all Americans aboard the ship to follow the guidance of health officials as we work to bring you home safely,” the agency said.
The others who exited the ship on April 24 were individuals from Canada, Denmark, Germany, the Netherlands, New Zealand, Switzerland, Sweden, Singapore, St. Kitts and Nevis, Turkey and the United Kingdom.
Of the remaining passengers still aboard the ship headed for Spain’s Canary Islands, California Department of Public Health said none were ill as of Friday.
How many people have been infected?
The number of lab-confirmed hantavirus cases has risen to five, according to the WHO. There are three additional suspected cases.
A timeline of reported cases of hantavirus aboard the cruise ship can be found here.
The WHO is monitoring reports of other people with symptoms “who may have had contact with one of the passengers. In each case, we are in close contact with the relevant authorities,” Tedros said.
The first passenger to have been infected, a Dutchman, became sick aboard the cruise ship on April 6 and died on April 11.
No samples were taken, because his symptoms were similar to other respiratory diseases. His widow left the ship with his body on April 24 during the scheduled stop at St. Helena.
“She deteriorated during a flight to Johannesburg on the 25th of April and died the next day,” Tedros said.
Before boarding the cruise ship, the Dutch couple had traveled through Argentina, Chile and Uruguay on a bird-watching trip, “which included visits to sites where the species of rat that is known to carry Andes virus was present,” Tedros said.
After leaving the ship, the woman was briefly aboard a KLM aircraft in Johannesburg bound for Amsterdam but was barred from the flight due to her medical condition, the airline said in a statement.
Dutch news outlets reported that a flight attendant on a KLM airplane — who briefly had contact with the widow — started feeling sick and had mild symptoms and was in isolation at a hospital in Amsterdam.
The flight attendant has since tested negative for the Andes virus, Dr. Jeremy Faust, an emergency medicine physician, wrote on his Substack blog, Inside Medicine, citing a text message sent to him by Tedros.
“It is still possible that the flight attendant contracted the Andes virus. However, given our understanding of the virus, this information means that the flight attendant’s symptoms are not caused by the Andes hantavirus, but by some other medical illness,” Faust wrote.
More cases may be reported, because the incubation period — the time it takes between exposure to the virus and the onset of illness — for the Andes strain of the hantavirus is up to six weeks.
What we know about hantavirus
There are roughly 50 identified species of hantavirus. The virus that’s found in the Americas tends to cause a cardiopulmonary syndrome, a condition that affects the heart and the lungs, according to Frank.
There have been 890 laboratory-confirmed cases of hantavirus disease reported in the U.S. since surveillance began in 1993, according to the most recent data from the CDC.
From 1980 to 2025, 99 California residents have been diagnosed with a hantavirus infection, according to the California Department of Public Health.
CDC officials said 38% of people who develop respiratory symptoms may die from the disease.
Still, the data suggest that contracting hantavirus is rare, said Dr. Afif El-Hasan, member of the American Lung Assn.’s national board of directors.
There is no vaccine or specific antiviral medicine for hantavirius.
Intensive-care treatment may include intubation and oxygen therapy, fluid replacement and use of medications to lower blood pressure, according to the American Lung Assn.
The signs of hantavirus
Early symptoms of hantavirus are similar to the flu and include fatigue, fever and muscle aches, according to the CDC. Symptoms start to develop within one to eight weeks after contact with an infected rodent.
Half of those who contract the virus also experience headaches, dizziness, chills, nausea, vomiting, diarrhea and abdominal pain.
Four to 10 days after the initial phase of the illness, another round of symptoms can develop, which include coughing, shortness of breath and possible tightness in the chest as the lungs fill with fluid.
Even though contracting hantavirus in the U.S. continues to be a rare event, El-Hasan said, people should take these initial symptoms seriously and promptly seek medical care.
How to protect yourself
Hantavirus cases can occur year-round, but the peak seasons in the United States are the spring and summer, which coincide with the reproductive seasons for deer mice.
To lessen your risk of infection, keep wild rodents out of your home and other enclosed spaces by sealing any holes and placing snap traps.
If you find evidence of mice, wear personal protective equipment and disinfect the area. When you’re done, put everything, including cleaning materials, in a bag and toss it in your trash bin.
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