FDA approves new type of non-opioid pain medication, 1st of its kind in more than 20 years
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(NEW YORK) — The U.S. Food and Drug Administration (FDA) on Thursday approved a new type of prescription pain medication for adults to treat moderate to severe acute pain.
The drug, called Journavx (suzetrigine) and manufactured by biotech company Vertex Pharmaceuticals, is a non-opioid painkiller, which doesn’t have addictive properties, unlike opioids often used for this type of pain.
This is the first class of non-opioid pain medication approved to treat moderate to severe acute pain approved by the FDA in more than 20 years.
“Today’s approval is an important public health milestone in acute pain management,” said Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, in a press release. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”
In two clinical trials, tested on adults between ages 18 and 80, Journavx was found to reduce moderate to severe acute pain for adults from baseline by about 50% in 48 hours.
The average time to meaningful pain relief ranged from two to four hours, compared to eight hours in the placebo group.
Journavx works by inhibiting the NaV1.8 pain signal in the peripheral nervous system. This channel is not expressed in the brain or anywhere else in the central nervous system, therefore the drug does not have addictive properties like opioids, according to Vertex.
Journavx was found to be as similarly effective as hydrocodone, an opioid pain medication, for reducing acute pain, with the added benefit of being a non-opioid and non-addictive drug.
In another clinical trial, the drug was tested in patients with a broader range of surgical and non-surgical acute pain conditions and was found to be safe and effective.
More than 80% of patients in this clinical trial rated Journavx as a good, very good or excellent pain medication when investigating multiple acute pain types.
The new drug “offers a safer option for managing moderate-to-severe acute pain, reducing reliance on opioids,” Dr. Jianguo Cheng, a professor of anesthesiology and medical director of the Cleveland Clinic Consortium for Pain at Cleveland Clinic, who was not involved in the clinical trials, told ABC News. “It offers rapid relief and can be integrated into postoperative pain protocols or acute pain scenarios where immediate relief is critical.”
“By managing acute pain effectively, [Journavx] may help prevent the transition to chronic pain, reducing the need for long-term pain management strategies,” he added.
(WASHINGTON) — Measles is continuing to spread across the United States, as outbreaks grow in western Texas and New Mexico.
Between the two states, 256 cases have been confirmed as of Thursday, mostly in those who are unvaccinated or with unknown vaccination status, according to state health officials. At least one unvaccinated school-aged child in Texas has died and another suspected death is being investigated in New Mexico in an unvaccinated adult. At least 10 other states have also confirmed cases, according to the Centers for Disease Control and Prevention.
As health care professionals work to care for patients, they are also attempting to combat the proliferation of misinformation about how to prevent and treat the disease, some tell ABC News.
Health and Human Services Secretary Robert F. Kennedy Jr. has been one of the prominent voices on measles, making comments that public health experts say are not accurate.
In multiple interviews, Kennedy has claimed that vitamin A and cod liver oil are effective treatments for measles. He also said that poor diet contributes to severe cases of measles and that — while vaccines prevent illness — they also cause severe illnesses and even death.
Some public health experts told ABC News these statements are not rooted in scientific evidence and could be quite dangerous for the public.
“I think it’s really important to try to stay away from these ideas of fringe theories or ideas that have not been scientifically proven,” Kirsten Hokeness, director of the school of health and behavioral sciences at Bryant University, in Rhode Island, told ABC News.
Vitamin A as a form of treatment
During an interview on Fox News with Sean Hannity on Tuesday, Kennedy said that HHS was currently providing vitamin A to measles patients for treatment. He claimed vitamin A can “dramatically” reduce measles deaths.
The World Health Organization recommends two doses of vitamin A in children and adults with measles to restore low vitamin A levels, which can help prevent eye damage and blindness.
However, experts who spoke with ABC News said it is not an antiviral treatment against measles (meaning it does not prevent infections), nor is there one available.
“Because it has been described that patients with vitamin A deficiency can have a more severe course, the WHO recommends low doses of vitamin A for children diagnosed with measles,” Dr. Carla Garcia Carreno, a pediatric infectious disease specialist at Children’s Medical Center Plano in Texas, told ABC News. “This is a supplementation in case of deficiency, and it is not intended to treat the virus. High doses of vitamin A can have serious consequences.”
“Neither vitamin A nor cod liver oil will treat measles,” she concluded.
Poor diet linked to severe measles disease
Kennedy has claimed that poor nutrition plays a role in causing severe measles disease and that a healthy diet can lessen severity.
While malnutrition can be a factor in severe disease, malnutrition and nutritional deficits in measles patients have historically been seen in underdeveloped countries, according to experts.
Additionally, studies have found that mass nutritional supplementation “followed by an increase in vaccination coverage” can reduce measles infection and mortality.
“Certainly, good nutrition can promote a healthy immune system, and it’s a good idea for everyone to try to maintain good nutrition, but it’s certainly not a substitute for vaccination,” Dr. Scott Weaver, director of the Institute for Human Infections and Immunity at the University of Texas Medical Branch, told ABC News. “There’s no evidence that it can prevent infection, no evidence that it can prevent an infected person from spreading the virus and contributing to one of these outbreaks.”
“So, I want to be very clear, good nutrition is absolutely no substitute for vaccination to prevent someone’s own risk for developing severe, maybe fatal, measles,” he added.
Claims about the safety of the measles vaccine
The CDC currently recommends that people receive two doses of the measles, mumps, rubella vaccine, the first at ages 12 to 15 months and the second between 4 and 6 years old.
One dose is 93% effective, and two doses are 97% effective, the CDC says. Most vaccinated adults don’t need a booster.
Kennedy has said vaccines do “stop the spread of the disease” but also said they cause “adverse events.”
“It does cause deaths every year. It causes all the illnesses that measles itself [causes], encephalitis and blindness, et cetera,” he told Hannity, without providing evidence.
Weaver said there is no vaccine that is without risks but that the MMR vaccine is incredibly safe and effective.
“There’s no evidence that it has severe outcomes … similar to what the measles virus infection causes,” he told ABC News. “It certainly can cause very minor reactions at the site of injection, like just about every vaccine, but it’s one of the safest vaccines that’s ever been developed.”
Weaver added that the risks of complications from a measles infection far outweigh any risks from the MMR vaccine.
As for Kennedy’s unfounded claim that the MMR vaccine causes death, a 2015 CDC review published in the journal Vaccine found such claims are deaths reported to the U.S. Vaccine Adverse Event Reporting System – a voluntary reporting system “that accepts any submitted report of an adverse event without judging its clinical significance or whether it was caused by a vaccination.”
The review found that many of the deaths reported to VAERS claiming to be linked to the MMR included children who has serious underlying medical conditions or had deaths that were unrelated to the vaccine, including accidental deaths.
“These complete VAERS reports and any accompanying medical records, autopsy reports and death certificates have been reviewed in depth by FDA and CDC physicians and no concerning patterns have emerged that would suggest a causal relationship with the MMR vaccine and death,” the review stated.
Questioning ‘benefits’ of measles and fatality rate
Kennedy claimed in an interview with Fox News senior medical analyst Dr. Marc Seigel over the weekend that is “almost impossible” for measles to kill a healthy individual.
Some people who contract measles may suffer severe complications as a result of infection. While those most at risk include children younger than age 5, pregnant people and those with weakened immune systems, anybody can experience complications.
About in 1 in 5 unvaccinated people who contract measles are hospitalized and about 1 in 20 children with measles develop pneumonia, which is the most common cause of death in young children who get infected.
About one in 10 children infected with measles develop ear infections as well, which can lead to hearing loss, data shows.
Additionally, about 1 out of every 1,000 children with measles will develop encephalitis — which is the swelling of the brain and can lead to brain damage — and up to 3 out of every 1,000 children with measles will die from respiratory and neurologic complications, the CDC says.
Recently, Texas health officials reported the death of an unvaccinated school-aged child, the first death from measles recorded in the U.S. in a decade. The child was healthy and had no preexisting conditions, officials said.
“The CDC estimates that 1 in 5 people [who] get infected with measles ends up in the hospital,” Hokeness said. “So, this approach to relying on sort of this natural immunity doesn’t make sense when we have a vaccine which prevents it in the first place.”
“But, in short, there’s really no benefit to this idea of natural immunity and naturally acquiring the virus. That’s why we’ve developed the vaccines that work so well,” she added.
Kennedy also claimed in his interview that natural immunity from measles may protect against cancer and heart disease. There is no evidence to suggest either of those are true, experts said.
“If you want to take your chances with getting natural infection, hoping that there might be some very small benefit to that, it’s a very big risk to take, because you may very well get severe measles infection,” Weaver said.
Overall, experts advised relying on scientifically proven medical information.
“We should leverage the knowledge that we’ve gained over the years and not spend our time focusing on alternative possibilities,” she said.
(WASHINGTON) — Researchers who had millions of dollars’ worth of grants terminated by the National Institutes of Health (NIH) are suing the federal government in the hopes of stopping any further research cancellations.
The lawsuit was filed on Wednesday evening against the NIH and its director Dr. Jay Bhattacharya, as well as the Department of Health and Human Services (HHS) and HHS Secretary Robert F. Kennedy, Jr.
Among the plaintiffs are Dr. Brittany Charlton, an associate professor in the department of epidemiology at the Harvard T.H. Chan School of Public Health, who said all of her grants were terminated because they allegedly “no longer [effectuate] agency priorities,” according to termination letters.
“Why am I standing up? I am a scientist, and therefore not a lawyer, but I appreciate that contract law is complex, and yet NIH’s contract cancellations set off my alarm bell,” she told ABC News in a statement.
Co-plaintiffs include the American Public Health Association; Ibis Reproductive Health; and United Auto Workers as well as three other researchers.
Both the NIH and the HHS told ABC News that they don’t comment on ongoing litigation.
Over the past several weeks, active research grants related to studies involving LGBTQ+ issues, gender identity and diversity, equity and inclusion (DEI) have been canceled at the NIH because they allegedly do not serve the “priorities” of President Donald Trump’s administration.
As of late March, more than 900 grants have been terminated, an NIH official with knowledge of the matter, who asked not to be named, told ABC News.
The terminations come after Trump passed a flurry of executive orders including vowing to “defend women from gender ideology extremism,” which has led to new guidance, like that from HHS, which now only recognizes two sexes.
The administration has also issued several executive orders aiming to dismantle DEI initiatives.
In previous termination letters, viewed by ABC News, they state that, “Research programs based on gender identity are often unscientific, have little identifiable return on investment, and do nothing to enhance the health of many Americans. Many such studies ignore, rather than seriously examine, biological realities. It is the policy of NIH not to prioritize these research programs.”
The lawsuit alleges that the grant terminations are a “reckless and illegal purge to stamp out NIH-funded research that addresses topics and populations that they disfavor.”
Charlton said she was alarmed by Project 2025 — a nearly 1,000-page document of policy proposals unveiled by the Heritage Foundation during the 2024 campaign intended to guide the next conservative administration — which allegedly attacked fields like hers, centering on LGBTQ+ health research, as “junk gender science,” she said.
On the campaign trail, Trump tried to distance himself from Project 2025, saying he didn’t know anything about the proposals.
Five of Charlton’s grants were terminated, including a five-year grant, of which Charlton said she and her colleagues were in their fourth year, focused on documenting obstetrical outcomes for lesbian, gay and bisexual women, she said.
Another grant was focused on how to improve the experience of lesbian, gay and bisexual individuals who are trying to form their families, she said.
A third was research looking to understand how laws identified by the team as discriminatory affect mental health among LGBTQ+ teens and potentially lead to depression and suicide, according to Charlton.
Charlton said the cancellations are not only affecting her ability to conduct research but the ability to keep open the LGBTQ Health Center of Excellence — based at the Harvard T.H. Chan School of Public Health — of which she is the founding director.
“My current NIH research contracts are worth $15.9 million, of which $5.9 million still needs to be spent to finish our research,” Charlton said. “I have essentially no salary now, and I may need to shutter our newly launched LGBTQ Health Center of Excellence, which was a career goal of mine that I finally met when we launched less than a year ago.”
She went on, “These grant terminations may end my academic career, and I’ve already been forced to make really tough decisions like terminating staff, including our newly appointed center’s executive director.”
According to the lawsuit, Dr. Katie Edwards, a professor at the University of Michigan School of Social Work, has had at least six grants terminated worth about $11.9 million, including one studying sexual violence among men who fall under sexual minorities. She can no longer pay several of the roughly 50 staff members who are funded through the research grants, the lawsuit states.
Dr. Peter Lurie, president and CEO of the nonprofit Center for Science in the Public Interest, was a paid consultant and adviser on a grant evaluating the impacts of over-the-counter access to pre-exposure prophylaxis to reduce HIV transmission, according to the lawsuit. The grantee institution, Harvard Pilgrim Healthcare, received a termination letter from the NIH in late March, the lawsuit states.
Meanwhile Dr. Nicole Maphis — a postdoctoral fellow at the University of New Mexico’s School of Medicine — who was studying the link between alcohol use disorder and Alzheimer’s disease, applied for a MOSAIC grant, “intended to help diversify the profession,” according to the lawsuit. Her proposal was pulled and her current funding ends September 2025.
“Without additional funding, which the MOSAIC award would have provided, she will lose her job,” the lawsuit states.
Charlton said she is hopeful the lawsuit results in a preliminary injunction and therefore halts further NIH terminations.
“I believe these contracts are binding agreements and are constitutionally grounded,” she said. “It’s been less than 100 days since inauguration, and I’m concerned. Concerned about signs of growing authoritarianism, and yet there is absolutely hope executive orders can’t rewrite laws, and I pray courts ensure justice, pursuing truth, including via science, unites us, and it’s the only way to ensure a healthier future for all.”
(AUSTIN, Texas) — The measles outbreak in western Texas is continuing to grow with 25 cases confirmed over the last five days, bringing the total to 223 cases, according to new data published Tuesday.
Almost all of the cases are in unvaccinated individuals or in individuals whose vaccination status is unknown, with 80 unvaccinated and 138 of unknown status, according to the Texas Department of State Health Services (DSHS). At least 29 people have been hospitalized so far.
Just five cases have occurred in people vaccinated with one dose of the measles, mumps, rubella (MMR) vaccine, according to the data.
This is a developing story. Please check back for updates.
