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.
(NEW YORK) — More than 1 million children may have been affected by long COVID in 2023, new federal data published Monday suggests.
Long COVID, a condition that occurs when patients still have symptoms at least three months after clearing infection, has been well-documented in adults, but its impact on children has been less clear.
Researchers from two divisions within the Centers for Disease Control and Prevention looked at results from the 2023 National Health Interview Survey, a nationwide survey that monitors the health of the U.S. population.
One child aged 17 or under was randomly selected from each sample household within the survey, and parents responded to questions about whether their child had previous COVID-19 illness, if the child had symptoms lasting three months or longer and if the child still had those symptoms at the time of interview.
Results of the analysis, published in the journal JAMA Pediatrics, showed approximately 1.01 million children, or 1.4%, are believed to have ever experienced long COVID in 2023 and about 293,000, or 0.4%, were experiencing the condition when the survey was being conducted.
This is similar to the 1.3%, or about 1 million, of children ever estimated to have had long COVID in 2022, according to the authors.
Children between ages 12 and 17 were most likely to have ever experienced long COVID or to still have the condition. Long COVID prevalence was also higher among Hispanic and non-Hispanic white children compared to non-Hispanic Black and Asian children.
Long COVID was also most common among children with a family income of under $100,000 and of parents with an education level of an associate’s degree or less.
Among children currently experiencing long COVID at the time of interview, 80% reported to have some level of activity limitation compared with before they had COVID-19.
“The large proportion of children experiencing [long COVID] with any activity limitation highlights the need to examine the severity of activity limitation, functional outcomes, and days lost from school,” the authors wrote.
The authors said there may be an under-reporting of long COVID in younger children due to difficulty with the verbalization of their symptoms.
Long COVID most often occurs in people who had severe illness, but anyone can develop the condition, according to the CDC. People who are not vaccinated against COVID-19 are at higher risk of developing long COVID, the agency says.
Scientists are not sure what causes long COVID but have identified risk factors including having underlying conditions.
(NEW YORK) — If you’re feeling hungover from New Year’s Eve champagne or had one too many boozy eggnogs over the holidays, let January be a fresh start.
Taking the challenge of going dry in January, or Dry January, i.e. having no alcohol for the entire month, is one resolution that might actually make you healthier.
The Dry January campaign was started in 2013 by Alcohol Change U.K., a charity focused on reducing alcohol harm. For the past several years, the initiative has proved popular in the United States and other countries too.
What are the health benefits of Dry January?
While research on how quitting alcohol for a month affects your body is still limited, several studies have shown psychological and health benefits.
Over one dozen staff members at the magazine New Scientist teamed up with researchers at the Institute for Liver and Digestive Health at the University College London Medical School in 2013 to investigate the benefits of Dry January.
The staff members, who all considered themselves “normal” drinkers, underwent baseline testing with blood samples, liver ultrasound scans and questionnaires. For the next five weeks, 10 of them stopped drinking and four drank their normal amounts.
The people who stopped drinking had lower levels of liver fat (which can be a precursor to liver damage), improved blood sugars and lower cholesterol than they did at the beginning of the month. They also reported improved sleep and concentration. In contrast, the four people who kept drinking saw no benefit.
Another study out of the U.K. had nearly 100 participants abstain from drinking alcohol for a month and another nearly 50 participants continue drinking alcohol as normal.
They found that moderate-heavy drinkers who took a break from alcohol had improved insulin resistance, weight, blood pressure, and cancer-related growth factors.
The researchers do warn, however, that the study does not show that a short-term ‘detox’ period is all that is required to ‘refresh’ the liver or achieve other health gains. Abstaining from alcohol for a month is only one part of addressing negative effects from longer-term alcohol consumption.
People who drink excessive amounts of alcohol are at higher risk of death and many medical conditions.
People who drink unhealthy amounts of alcohol are more likely to have high blood pressure, heart disease, liver disease, nerve damage, infections including pneumonia and even certain cancers like breast cancer.
Dr. Fulton Crews, director of the Center for Alcohol Studies at the University of North Carolina at Chapel Hill, said attempting to stop drinking for Dry January is a good opportunity for people to see if they have an actual addiction to alcohol.
“Many people are in denial about their drinking and hazardous drinking, and if they try to stop and are not able to, it really points out to them their weakness,” Crews told ABC News. “If they can’t stop for a month, they would realize that they have a problem.
“Either that or they do it, and they realize it’s not that hard for them,” said Crews, who described Dry January as a “good idea.”
Experts say Dry January may be especially helpful to those who consistently drink over the recommended amount of two drinks per day for men and one drink per day for women.
Excessive drinking includes binge drinking, defined as consuming five or more drinks for men in a single occasion and four or more drinks for women, and heavy drinking, defined as consuming 15 or more drinks per week for men or eight drinks or more for women). A standard drink is 12 ounces of a regular beer, 8 ounces of a malt liquor, 5 ounces of a glass of wine, and 1.5 ounces of a spirit, according to the Centers for Disease Control and Prevention.
For those individuals who drink alcohol within the recommended limits, Crews said he is “not sure there would be any observable benefits.”
“I don’t see any clear potential for a moderate drinking person to stop drinking,” he said.
If you do choose to participate in Dry January, Crews shared his advice for sticking to the program.
“Try to avoid temptation by maybe putting all the alcohol out of the house,” he said.
Does Dry January prompt bigger change for some?
Staying dry for January may also help jump-start people to give up alcohol for longer.
Although most people who participate in Dry January return to drinking, up to 8% stay dry six months later, according to Public Health England and the British Medical Journal.
And those who go back to drinking drink less. A 2015 study conducted in the U.K. and published in the journal Health Psychology found that people who participated in Dry January drank less often, had fewer drinks when they did drink and were drunk less often six months after Dry January was completed.
Dry January participants were also better able to refuse alcoholic drinks. These benefits were even seen in people who did not complete the whole month of Dry January.
It might seem daunting to stop drinking alcohol for a whole month. But a 2020 Alcohol and Alcoholism study found that nearly 70% of people completed the Dry January Challenge in 2019.
If you are concerned about yourself or a loved one, call the Substance Abuse and Mental Health Services Administration’s (SAMSA) confidential, free, 24-hour-a-day, 365-day-a-year helpline at 1-800-662-HELP (4357). For information and resources about alcohol-related problems and health, visit the website of the National Institute of Alcohol Abuse and Alcoholism (NIAAA) HERE.
Editor’s note: This piece was originally published on Jan. 3, 2018.
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(NEW YORK) — As world leaders mourn the death of former President Jimmy Carter and remark on his political and policy legacy, doctors are remembering his efforts to prevent disease, and his legacy in furthering global public health.
The 39th president spent five decades working to eradicate a parasitic disease, helped organize a major-drug donation program, and made advancements addressing the mental health crisis in the U.S.
Dr. Julie Jacobson, currently a managing partner of the nonprofit Bridges to Development, helped to provide funding for the Carter Center’s work in the Americas, Nigeria and Ethiopia while she worked for the Bill & Melinda Gates Foundation for over a decade.
“He was hugely influential, I think particularly for the diseases that most of the world doesn’t appreciate even exist,” Jacobson told ABC News of Jimmy Carter’s work. “He was a true champion for the neglected tropical diseases, which are some of the most common infections of people who live with the least resources. And he found these diseases and then really wanted to do something about them, and used his voice, his influence, his passion, to continue to push forward where others were really not interested.”
Near-eradication of Guinea worm disease
Following his loss to Ronald Reagan in the 1980 presidential election, Carter founded the Carter Center in 1982, a non-profit organization that “seeks to prevent and resolve conflicts, enhance freedom and democracy, and improve health,” according to the Center’s website.
Among the organization’s many efforts, the Carter Center helped spearhead a successful international campaign with the goal of eradicating dracunculiasis, also known as Guinea worm disease, a parasitic infection caused by consuming contaminated drinking water.
Water from ponds or other stagnant bodies of water can contain tiny crustaceans commonly known as water fleas, which in turn can be infected with Guinea worm larvae, according to the Centers for Disease Control and Prevention (CDC).
About one year after infecting a human host, the Guinea worm creates a blister on the skin and emerges from it, which can cause burning pain, fever and swelling, according to the CDC and the World Health Organization.
“Nobody else wanted to take it on,” Jimmy Carter told ABC News’ George Stephanopoulos during a 2015 interview on “Good Morning America”. “So, I decided to take it on.”
In 1986, Guinea worm disease afflicted 3.5 million people every year in 21 African and Asian countries. Disease incidence has since been reduced by 99.99%, to just 14 “provisional” human cases in 2023, according to the Carter Center.
Jacobson said that success is even more remarkable because there are no vaccines available to prevent Guinea worm disease and no drugs to treat it. Tracking Guinea worm disease, according to Jacobson, involves following possible cases for a year to determine if they are infected, checking to see if infected humans have any infected water sources near them, and monitoring the community as a whole.
“To think that you could eradicate a disease without any tools is really still just a crazy idea, but he did it with perseverance and working with people in the grassroots within communities and putting together teams of people to go and work with people in those communities and empower the communities,” Jacobson said.
The Carter Center says if efforts are successful, Guinea worm disease could become the second human disease in history to be completely eradicated, after smallpox, and the first to be done without the use of a vaccine or medicine.
Carter told ABC News during the 2015 interview that eradicating the disease entirely was his goal: “I think this is going to be a great achievement for, not for me, but for the people that have been afflicted and for the entire world to see diseases like this eradicated.”
Mass drug distribution for river blindness
The Carter Center also works to fight other preventable diseases, including the parasitic infections schistosomiasis and lymphatic filariasis – more commonly known as snail fever and elephantiasis, respectively – as well as trachoma, which is one of the world’s leading causes of preventable blindness. It’s also working with the governments of Haiti and the Dominican Republic to eliminate lymphatic filariasis and malaria from the island of Hispaniola, which both countries share and which is “the last reservoir in the Caribbean for both diseases,” according to the Carter Center.
Carter and his organization also played a part in organizing a major drug-donation program to help eliminate onchocerciasis, also known as river blindness, which is transmitted to human through repeated bites of infected blackflies, according to the CDC.
Pharmaceutical company Merck & Co. had been implementing field studies in Africa which showed that the drug ivermectin was effective at treating river blindness in humans. The Carter Center partnered with Merck to mass-distribute ivermectin, brand name Mectizan, “as much as needed for as long as needed” in Africa and Latin America. To date, the Carter Center has assisted in distributing more than 500 million treatments of Mectizan, according to Merck.
In 1995, Carter negotiated a two-month cease-fire in Sudan to allow health care workers there to more safely help eradicate Guinea worm disease, prevent river blindness, and vaccinate children against polio.
“When we have known solutions, it is ethical to make sure they’re available to the people who need it most,” Dr. Usha Ramakrishnan, chair of the Department of Global Health at Emory University’s Rollins School of Public Health, told ABC News. “And that’s where we were with river blindness. There was a treatment, but improving access to medications, making it affordable, reaching the people they need was very much along the lines of the work [the Carter Center] was doing.”
Addressing mental health
Carter was also committed to tackling mental health issues. During his presidency, he created the Presidential Commission on Mental Health, which recommended a national plan to care for people with chronic mental illness.
Although it was never adopted as policy by the Reagan administration, the plan’s recommended strategies were adopted by some mental health advocacy groups to “make gains in the 1980s,” according to one study.
Carter also signed into law the Mental Health Systems Act of 1980, which provided funding to community mental health centers.
After his presidency, Carter and former first lady Rosalynn Carter continued working to improve access to mental health.
Ramakrishnan said the Carters’ work helped to reduce some of the stigma associated with mental health.
“There continues to be a lot of stigma, but they truly got it out [in] the conversation and mainstreaming mental health as an important aspect of health and well-being,” Ramakrishnan said. “There’s still a lot of challenges, and there are many capable people that they have mentored and trained who are carrying that mantle forward.”