FDA approves new type of non-opioid pain medication, 1st of its kind in more than 20 years
Sarah Silbiger/Getty Images
(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.
(NEW YORK) — Kansas is facing the largest recorded tuberculosis outbreak in U.S. history, according to local health officials.
As of Jan. 24, there have been 67 confirmed cases of active TB including 60 in Wyandotte County and seven in Johnson County, according to the Kanas Department of Health and Environment.
Additionally, there are 79 confirmed latent TB cases, including 77 in Wyandotte County and two in Johnson County. Wyandotte County contains part of Kansas City and Johnson County is just southwest of Kansas City.
Cases linked to the outbreak were first reported in January 2024, according to KDHE. So far, there have been two deaths related to the outbreak, both of which occurred last year.
“The current Kansas City, Kan. Metro tuberculosis (TB) outbreak is the largest documented outbreak in U.S. history, presently (since the 1950s, when the Centers for Disease Control and Prevention (CDC) started monitoring and reporting TB cases),” KDHE said in a statement. “This outbreak is still ongoing, which means that there could be more cases.”
Health officials say the risk to people living in surrounding counties and to the general public is “very low,” and that the department is following guidance from the Centers for Disease Control and Prevention.
TB is a disease caused by a type of bacteria called Mycobacterium tuberculosis, according to the CDC. It is one of the world’s leading infectious disease killers, the federal health agency says.
TB is spread in the air from one person to another. When a person with TB coughs, speaks or sings, germs are expelled into the air — where they can linger for several hours — before another person breathes in the air and becomes infected.
Signs and symptoms include a cough that lasts for three weeks or longer, coughing up blood or phlegm, chest pain, weakness, fatigue, weight loss, loss of appetite, fever, chills and night sweats, according to the CDC.
Some people become infected with TB germs that live in the body for years without causing illness. This is known as inactive TB or latent TB.
People with inactive TB do not feel ill, do not have symptoms and cannot spread germs to other people, the CDC says. However, without receiving treatment, people with inactive TB can develop active TB.
Last year, the U.S. saw more than 8,700 cases of TB, according to CDC data. Although TB cases have been steadily declining since the mid 1990s, rates increased in 2021, 2022 and 2023, with 2023 matching pre-pandemic levels.
There are several treatment regimens for TB disease that may last anywhere from four months to nine months depending on the course of treatment. Health care providers may consider specific regimens for patients with co-existing medical conditions such as diabetes or HIV.
A vaccine, known as Bacille Calmette-Guérin (BCG), is commonly given to children in countries where TB is common, although it is generally not recommended in the U.S. due to the low risk of infection with the bacteria, variable vaccine effectiveness among adults, and the vaccine’s potential interference with TB tests, the CDC notes. The BCG vaccine often leaves a scar where the recipient was given the shot.
Human Bird Flu Cases in the U.S. as of January 6, 2025. Image by ABC News. Data via CDC.
(NEW YORK) — In the nearly nine months since the first human case of bird flu was detected in the United States, the virus has continued to spread.
The outbreak infected hundreds of herds and millions of birds before it spread to humans. As of Jan. 6, there have been 66 human cases of bird flu reported in 10 states, according to data from the Centers for Disease Control and Prevention (CDC).
Almost all confirmed cases involve direct contact with infected cattle or infected livestock.
On Tuesday, the first death of a human bird flu patient was reported in Louisiana. The patient was over the age of 65 and had underlying medical conditions, according to health officials.
The CDC says there is currently no evidence of human-to-human transmission and the risk to the general public is low.
However, public health experts say they are worried the virus could mutate and become more transmissible, amplifying the need to ramp up testing and to stockpile vaccines.
Dr. Tony Moody, a professor of pediatrics and infectious diseases specialist at Duke University, said the fact that cases have yet to pass from human to human is “both reassuring, but not completely reassuring.”
He told ABC News, “What we’re concerned about is that, eventually, we might get a variation of this strain that could pass from person to person. That’s really what we’re going to need to see, I think, to get substantial human cases and the potential for a new pandemic strain.”
He added, “So, in terms of peering into the crystal ball for 2025…I think the concern is whether or not we’re going to see something change that will turn it into a pandemic strain that could then really be a problem,” he added.
Fears of mutation or a combination virus
One fear experts have is that the virus will continue to mutate in a way that will cause more human-to-human transmissibility. The experts say that every new human case of bird flu allows the virus an opportunity to mutate.
Recent CDC data found mutations in samples of bird flu collected from the Louisiana patient. What’s more, the mutations were not found in poultry samples collected on the patient’s property, suggesting the changes appeared after the patient became infected.
Moody said that because the virus has not yet mutated in a way to spread more easily between humans, he’s not sure if or when it will happen.
“Given the number of cows that have been infected, the number of birds that have been infected and the fact that the virus essentially mutates every time it replicates, I’m kind of surprised that the mutations that they’re talking about haven’t happened yet,” he said. “So, I actually think there’s a bigger barrier to it becoming a real problem.”
Dr. Peter Hotez, co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, said he believes there is a more likely scenario of the virus becoming more transmissible: an individual getting infected with bird flu and seasonal influenza at the same time.
He said this could lead to the virus “reassorting” to produce a hybrid, or recombinant, virus that could then transmit more easily from person to person.
“Everyone’s focusing on the potential for mutation; that is a serious concern for some,” he told ABC News. “The greater probability is that there could be a reassortment, what could ignite the pandemic or an epidemic.”
The experts say there is no evidence the virus is currently heading towards an epidemic or pandemic, but there has already been one case of severe disease.
Different genotypes, or genetic makeup of the virus, means there could more severe cases.
“What we’ve seen with [bird flu] in the United States is that the particular genotype that’s associated with dairy cows has primarily caused more mild disease in people,” Dr. Meghan Davis, an associate professor of environmental health and engineering at Johns Hopkins Bloomberg School of Public Health, told ABC News.
“What we’ve seen with the case in Louisiana … is caused by a different genotype, one that has been circulating in the wild birds, and these are much more severe cases,” she continued. “This highlights the ability of avian influenzas to cause a wide variety of disease … and I think it is possible that we’re going to see that moving forward.”
Making testing more available
The U.S. has begun ramping up testing with the U.S. Department of Agriculture issuing a federal order for raw milk samples nationwide to be collected and tested and the Food and Drug Administration announcing it is collecting samples of aged raw cow’s milk cheese to be tested.
However, for 2025, Hotez said he believes testing needs to be made more readily available to physicians, especially during flu season.
He said there are likely cases of bird flu going undiagnosed, and testing made more available in health care settings would catch those flying under the radar.
“I think one of the problems that we have, especially as we move into influenza season, there’s the risk that, if you’re a physician, if they want to do influenza testing, they’re only really testing for the usual seasonal influenza, they’re not testing for [bird flu],” he said. “Otherwise, we’re never going to fully know the actual extent of the problem.”
Stockpiling bird flu vaccines
In early July, the U.S. government awarded Moderna $176 million to develop and test a bird flu vaccine using mRNA technology, which is the same technology used for the COVID vaccine.
In October, federal health officials announced they were providing $72 million to vaccine manufacturers to help ensure currently available bird flu vaccines are ready to use, if needed.
There are currently no recommendations for anyone in the U.S. to be vaccinated against bird flu, but experts say that could change if the virus becomes more transmissible.
Moody said clinical trials for new vaccines are being conducted and there are already bird flu vaccines in a stockpile maintained by the U.S. government that have previously been licensed by the FDA.
However, these three vaccines were formulated to protect against older strains of bird flu so there are questions about their protectiveness.
“One of the difficulties in making a stockpile is you’re trying to predict the future. Picking which influenza is going to be a problem is always the difficult bit,” Moody said. “So, I think that those vaccines that are in the stockpile, based on the data that I’ve seen, have a pretty good chance of being helpful. Whether or not they’ll be the answer that’s a that’s a tougher question to address.”
He said the U.S. is in a better position currently to address bird flu if it becomes an epidemic or pandemic than the country was to address COVID in 2020.
“We know how to do this. We know how to make these vaccines. We know how to get everything rolled out, and so I think we are in a better position today,” Moody said.
(NEW YORK) — From a pig kidney transplant to restoring genetic deafness, 2024 was a year full of medical breakthroughs.
The breakthroughs include the discovery of a cause of an autoimmune disease, the development of a “game-changing” drug and potential hope for those experiencing end-stage organ failure.
Here are five of the biggest highlights in medical achievements this year:
Gene therapy restores hearing in children
Children with hereditary deafness regained their hearing thanks to a type of gene therapy, according to the results of a clinical trial published in the medical journal The Lancet in January.
Investigators from Mass Eye and Ear, a specialty hospital in Boston, examined six children who had a form of genetic deafness called DFNB9, which is caused by a gene mutation that interferes with the transmission of sound signals from the ear to the brain.
Gene therapy involved the use of an inactive virus carrying a functioning version of the gene, which was introduced into the inner ears of the six children.
After 26 weeks, five of the six children recovered their hearing and could even conduct “normal conversation.”
“Children with this genetic hearing loss…the only treatment option for them until now is [a] cochlear implant,” Dr. Zheng-Yi Chen, an associate scientist in the Eaton-Peabody Laboratories at Mass Eye and Ear and study co-investigator, told ABC News. “And of course, [a] cochlear implant can help them tremendously, but it’s with its own limitations.”
“But with this gene therapy, the children regain hearing, and they were able to speak. So, in a way, the life is totally transformed,” he continued. “This study really opened up the whole field that, in the future, we’ll be able to develop a treatment for other [types] of genetic hearing loss, for which there is no treatment at all at the moment.”
Groundbreaking animal organ transplant
Surgeons at Massachusetts General Hospital (MGH) conducted the world’s first genetically-edited pig kidney transplant into a living human in March 2024.
During a four-hour procedure, a surgical team connected the pig kidney’s blood vessels and ureter – the duct that carries urine from the kidney to the bladder – with those of 62-year-old Richard Slayman, a man living with end-stage kidney disease.
“For patients with kidney failure, we know that transplantation is the best treatment option, but unfortunately, we face an immense organ shortage,” Dr. Leonardo Riella, medical director of kidney transplantation at MGH, told ABC News. “So, we have over 100,000 patients waiting for a kidney transplant in the U.S., and more than 17 patients die every day on the waiting list.”
“So, the idea here is, how can we overcome this organ shortage barrier? And having kidneys from another species that could be delivered in a timely manner for these patients once they develop kidney failure could be game-changing for the entire field,” he added.
Slayman passed away in May of this year, but there is no evidence it was the result of the transplant, according to MGH.
Riella said over the course of Slayman’s care, much was learned about how to best deliver care when using animal organs for transplants in the hopes of making the treatment more widely available to patients waiting for a new organ.
A cause of lupus discovered
A team at Brigham & Women’s Hospital and Northwestern Medicine said they have discovered a cause of the autoimmune disease lupus and a possible way to reverse it.
Lupus sees the body’s immune system mistakenly attack its own healthy cells and tissues, which can cause inflammation and damage in organs or systems, according to the Centers for Disease Control and Prevention.
In a study, published in the journal Nature in July, researchers compared blood samples from 19 lupus patients to 19 patients without the condition and found imbalances in the types of T-cells lupus patients produce.
T-cells are a certain type of white blood cell that plays a crucial role in the body’s immune response to the disease.
“We’ve identified a fundamental imbalance in the immune responses that patients with lupus make, and we’ve defined specific mediators that can correct this imbalance to dampen the pathologic autoimmune response,” co-corresponding author Dr. Deepak Rao, a rheumatologist at Brigham and Women’s Hospital and co-director of its Center for Cellular Profiling, said in a press release at the time.
1st new class of schizophrenia drug in more than 3 decades
In September, the FDA approved the first new class of drug to treat people with schizophrenia in more than 30 years.
The pill, called Cobenfy – manufactured by Bristol Myers Squibb – combines two drugs, xanomeline and trospium chloride, and is taken twice a day.
Clinical trials showed the combination helped manage schizophrenia symptoms such as hallucinations, delusions and disorganized thinking.
Dr. René Kahn, chair of psychiatry at the Icahn School of Medicine at Mount Sinai, said it took many years to develop the first medications for schizophrenia, which are effective in preventing psychosis and work by blocking dopamine receptors.
“Blocking the dopamine receptor directly or indirectly is very unpleasant. Sometimes for patients, they can have unpleasant side effects. It can decrease their energy, it can make them feel depressed, and it can give them Parkinsonian side effects,” Kahn told ABC News.
He described Cobenfy as “game-changing in the sense that this is the first drug that doesn’t directly – with the emphasis on directly – influence the dopamine system and certainly doesn’t block dopamine receptors. So that’s very important, because it may show that we don’t have to directly block or affect the dopamine system but can do that through a different mechanism.”
Kahn said the next step will be monitoring the drug as it is prescribed to thousands of schizophrenia patients to ensure it works and that side effects are minimal.
1st over-the-counter combo flu and COVID test outside of emergency use
The FDA authorized the first over-the-counter combination COVID-19 and flu test outside of emergency use in October.
The Healgen Rapid Check COVID-19/Flu A&B Antigen Test can be purchased at a pharmacy or other stores without a prescription.
While there are other over-the-counter combination tests currently available, this is the first to be marketed to consumers using the traditional approval pathway outside of a public health emergency, according to the FDA.
