Connect with us

Science

FDA Approves Journavx Drug to Treat Pain Without Addiction Risk

Published

on

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.

Advertisement

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.

Advertisement

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.)

Advertisement

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.”

Advertisement

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.

Advertisement

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.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Science

Trump administration declares ‘war on sugar’ in overhaul of food guidelines

Published

on

Trump administration declares ‘war on sugar’ in overhaul of food guidelines

The Trump administration announced a major overhaul of American nutrition guidelines Wednesday, replacing the old, carbohydrate-heavy food pyramid with one that prioritizes protein, healthy fats and whole grains.

“Our government declares war on added sugar,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a White House press conference announcing the changes. “We are ending the war on saturated fats.”

“If a foreign adversary sought to destroy the health of our children, to cripple our economy, to weaken our national security, there would be no better strategy than to addict us to ultra-processed foods,” Kennedy said.

Improving U.S. eating habits and the availability of nutritious foods is an issue with broad bipartisan support, and has been a long-standing goal of Kennedy’s Make America Healthy Again movement.

During the press conference, he acknowledged both the American Medical Association and the American Assn. of Pediatrics for partnering on the new guidelines — two organizations that earlier this week condemned the administration’s decision to slash the number of diseases that U.S. children are vaccinated against.

Advertisement

“The American Medical Association applauds the administration’s new Dietary Guidelines for spotlighting the highly processed foods, sugar-sweetened beverages, and excess sodium that fuel heart disease, diabetes, obesity, and other chronic illnesses,” AMA president Bobby Mukkamala said in a statement.

Continue Reading

Science

Contributor: With high deductibles, even the insured are functionally uninsured

Published

on

Contributor: With high deductibles, even the insured are functionally uninsured

I recently saw a patient complaining of shortness of breath and a persistent cough. Worried he was developing pneumonia, I ordered a chest X-ray — a standard diagnostic tool. He refused. He hadn’t met his $3,000 deductible yet, and so his insurance would have required him to pay much or all of the cost for that scan. He assured me he would call if he got worse.

For him, the X-ray wasn’t a medical necessity, but it would have been a financial shock he couldn’t absorb. He chose to gamble on a cough, and five days later, he lost — ending up in the ICU with bilateral pneumonia. He survived, but the cost of his “savings” was a nearly fatal hospital stay and a bill that will quite likely bankrupt him. He is lucky he won’t be one of the 55,000 Americans to die from pneumonia each year.

As a physician associate in primary care, I serve as a frontline witness to this failure of the American approach to insurance. Medical professionals are taught that the barrier to health is biology: bacteria, viruses, genetics. But increasingly, the barrier is a policy framework that pressures insured Americans to gamble with their lives. High-deductible health plans seem affordable because their monthly premiums are lower than other plans’, but they create perverse incentives by discouraging patients from seeking and accepting diagnostics and treatments — sometimes turning minor, treatable issues into expensive, life-threatening emergencies. My patient’s gamble with his lungs is a microcosm of the much larger gamble we are taking with the American public.

The economic theory underpinning these high deductibles is known as “skin in the game.” The idea is that if patients are responsible for the first few thousand dollars of their care, they will become savvy consumers, shopping around for the best value and driving down healthcare costs.

But this logic collapses in the exam room. Healthcare is not a consumer good like a television or a used car. My patient was not in a position to “shop around” for a cheaper X-ray, nor was he qualified to determine if his cough was benign or deadly. The “skin in the game” theory assumes a level of medical literacy and market transparency that simply doesn’t exist in a moment of crisis. You can compare the specs of two SUVs; you cannot “shop around” for a life-saving diagnostic while gasping for air.

Advertisement

A 2025 poll from the Kaiser Family Foundation points to this reality, finding that up to 38% of insured American adults say they skipped or postponed necessary healthcare or medications in the past 12 months because of cost. In the same poll, 42% of those who skipped care admitted their health problem worsened as a result.

This self-inflicted public health crisis is set to deteriorate further. The Congressional Budget Office estimates roughly 15 million people will lose health coverage and become uninsured by 2034 because of Medicaid and Affordable Care Act marketplace cuts. That is without mentioning the millions more who will see their monthly premiums more than double if premium tax credits are allowed to expire. If that happens, not only will millions become uninsured but also millions more will downgrade to “bronze” plans with huge deductibles just to keep their premiums affordable. We are about to flood the system with “insured but functionally uninsured” patients.

I see the human cost of this “functional uninsurance” every week. These are patients who technically have coverage but are terrified to use it because their deductibles are so large they may exceed the individuals’ available cash or credit — or even their net worth. This creates a dangerous paradox: Americans are paying hundreds of dollars a month for a card in their wallet they cannot afford to use. They skip the annual physical, ignore the suspicious mole and ration their insulin — all while technically insured. By the time they arrive at my clinic, their disease has often progressed to a catastrophic event, from what could have been a cheap fix.

Federal spending on healthcare should not be considered charity; it is an investment in our collective future. We cannot expect our children to reach their full potential or our workforce to remain productive if basic healthcare needs are treated as a luxury. Inaction by Congress and the current administration to solve this crisis is legislative malpractice.

In medicine, we are trained to treat the underlying disease, not just the symptoms. The skipped visits and ignored prescriptions are merely symptoms; the disease is a policy framework that views healthcare as a commodity rather than a fundamental necessity. If we allow these cuts to proceed, we are ensuring that the American workforce becomes sicker, our hospitals more overwhelmed and our economy less resilient. We are walking willingly into a public health crisis that is entirely preventable.

Advertisement

Joseph Pollino is a primary care physician associate in Nevada.

Insights

L.A. Times Insights delivers AI-generated analysis on Voices content to offer all points of view. Insights does not appear on any news articles.

Viewpoint
This article generally aligns with a Center Left point of view. Learn more about this AI-generated analysis
Perspectives

The following AI-generated content is powered by Perplexity. The Los Angeles Times editorial staff does not create or edit the content.

Ideas expressed in the piece

  • High-deductible health plans create a barrier to necessary medical care, with patients avoiding diagnostics and treatments due to out-of-pocket cost concerns[1]. Research shows that 38% of insured American adults skipped or postponed necessary healthcare or medications in the past 12 months because of cost, with 42% reporting their health worsened as a result[1].

  • The economic theory of “skin in the game”—which assumes patients will shop around for better healthcare values if they have financial responsibility—fails in medical practice because patients lack the medical literacy to make informed decisions in moments of crisis and cannot realistically compare pricing for emergency or diagnostic services[1].

  • Rising deductibles are pushing enrollees toward bronze plans with deductibles averaging $7,476 in 2026, up from the average silver plan deductible of $5,304[1][4]. In California’s Covered California program, bronze plan enrollment has surged to more than one-third of new enrollees in 2026, compared to typically one in five[1].

  • Expiring federal premium tax credits will more than double out-of-pocket premiums for ACA marketplace enrollees in 2026, creating an expected 75% increase in average out-of-pocket premium payments[5]. This will force millions to either drop coverage or downgrade to bronze plans with massive deductibles, creating a population of “insured but functionally uninsured” people[1].

  • High-deductible plans pose particular dangers for patients with chronic conditions, with studies showing adults with diabetes involuntarily switched to high-deductible plans face 11% higher risk of hospitalization for heart attacks, 15% higher risk for strokes, and more than double the likelihood of blindness or end-stage kidney disease[4].

Different views on the topic

  • Expanding access to health savings accounts paired with bronze and catastrophic plans offers tax advantages that allow higher-income individuals to set aside tax-deductible contributions for qualified medical expenses, potentially offsetting higher out-of-pocket costs through strategic planning[3].

  • Employers and insurers emphasize that offering multiple plan options with varying deductibles and premiums enables employees to select plans matching their individual needs and healthcare usage patterns, allowing those who rarely use healthcare to save money through lower premiums[2]. Large employers increasingly offer three or more medical plan choices, with the expectation that employees choosing the right plan can unlock savings[2].

  • The expansion of catastrophic plans with streamlined enrollment processes and automatic display on HealthCare.gov is intended to make affordable coverage more accessible for certain income groups, particularly those above 400% of federal poverty level who lose subsidies[3].

  • Rising healthcare costs, including specialty drugs and new high-cost cell and gene therapies, are significant drivers requiring premium increases regardless of plan design[5]. Some insurers are managing affordability by discontinuing costly coverage—such as GLP-1 weight-loss medications—to reduce premium rate increases for broader plan members[5].

Advertisement
Continue Reading

Science

Trump administration slashes number of diseases U.S. children will be regularly vaccinated against

Published

on

Trump administration slashes number of diseases U.S. children will be regularly vaccinated against

The U.S. Department of Health and Human Services announced sweeping changes to the pediatric vaccine schedule on Monday, sharply cutting the number of diseases U.S. children will be regularly immunized against.

Under the new guidelines, the U.S. still recommends that all children be vaccinated against measles, mumps, rubella, polio, pertussis, tetanus, diphtheria, Haemophilus influenzae type B (Hib), pneumococcal disease, human papillomavirus (HPV) and varicella, better known as chickenpox.

Vaccines for all other diseases will now fall into one of two categories: recommended only for specific high-risk groups, or available through “shared clinical decision-making” — the administration’s preferred term for “optional.”

These include immunizations for hepatitis A and B, rotavirus, respiratory syncytial virus (RSV), bacterial meningitis, influenza and COVID-19. All these shots were previously recommended for all children.

Insurance companies will still be required to fully cover all childhood vaccines on the CDC schedule, including those now designated as optional, according to the Department of Health and Human Services.

Advertisement

Health Secretary Robert F. Kennedy Jr., a longtime vaccine critic, said in a statement that the new schedule “protects children, respects families, and rebuilds trust in public health.”

But pediatricians and public health officials widely condemned the shift, saying that it would lead to more uncertainty for patients and a resurgence of diseases that had been under control.

“The decision to weaken the childhood immunization schedule is misguided and dangerous,” said Dr. René Bravo, a pediatrician and president of the California Medical Assn. “Today’s decision undermines decades of evidence-based public health policy and sends a deeply confusing message to families at a time when vaccine confidence is already under strain.”

The American Academy of Pediatrics condemned the changes as “dangerous and unnecessary,” and said that it will continue to publish its own schedule of recommended immunizations. In September, California, Oregon, Washington and Hawaii announced that those four states would follow an independent immunization schedule based on recommendations from the AAP and other medical groups.

The federal changes have been anticipated since December, when President Trump signed a presidential memorandum directing the health department to update the pediatric vaccine schedule “to align with such scientific evidence and best practices from peer, developed countries.”

Advertisement

The new U.S. vaccination guidelines are much closer to those of Denmark, which routinely vaccinates its children against only 10 diseases.

As doctors and public health experts have pointed out, Denmark also has a robust system of government-funded universal healthcare, a smaller and more homogenous population, and a different disease burden.

“The vaccines that are recommended in any particular country reflect the diseases that are prevalent in that country,” said Dr. Kelly Gebo, dean of the Milken Institute School of Public Health at George Washington University. “Just because one country has a vaccine schedule that is perfectly reasonable for that country, it may not be at all reasonable” elsewhere.

Almost every pregnant woman in Denmark is screened for hepatitis B, for example. In the U.S., less than 85% of pregnant women are screened for the disease.

Instead, the U.S. has relied on universal vaccination to protect children whose mothers don’t receive adequate care during pregnancy. Hepatitis B has been nearly eliminated in the U.S. since the vaccine was introduced in 1991. Last month, a panel of Kennedy appointees voted to drop the CDC’s decades-old recommendation that all newborns be vaccinated against the disease at birth.

Advertisement

“Viruses and bacteria that were under control are being set free on our most vulnerable,” said Dr. James Alwine, a virologist and member of the nonprofit advocacy group Defend Public Health. “It may take one or two years for the tragic consequences to become clear, but this is like asking farmers in North Dakota to grow pineapples. It won’t work and can’t end well.”

Continue Reading
Advertisement

Trending