Health
FDA rejects MDMA as psychedelic-based treatment for mental health, PTSD
The U.S. Food and Drug Administration (FDA) announced Friday its rejection of MDMA as a treatment for PTSD.
The decision was based on “significant limitations” that “prevent the agency from concluding that the drug is safe and effective for the proposed indication,” the FDA stated, according to The Associated Press.
MDMA, also known as ecstasy or molly, is a psychedelic drug with effects that are similar to methamphetamine, according to the National Institute on Drug Abuse.
FDA PANEL REJECTS MDMA-ASSISTED THERAPIES FOR PTSD DESPITE HIGH HOPES FROM VETERANS
Veteran organizations have long been advocating for approval of psychedelic-assisted therapies to treat mental health challenges.
The U.S. Food and Drug Administration announced Friday its rejection of MDMA as a treatment for PTSD. (iStock)
The FDA’s decision comes nearly eight weeks after an FDA advisory committee voted 10-1 against the overall benefits of MDMA in treating PTSD.
The FDA has requested another Phase 3 trial to confirm the drug’s safety and efficacy.
Lykos Therapeutics, the California company that filed the drug application, said it plans to meet with the FDA to appeal the decision, according to reports.
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“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” Amy Emerson, the Lykos CEO, said in a statement from the company.
“While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the Advisory Committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature.”
Veteran organizations have long been advocating for approval of psychedelic-assisted therapies for treating mental health challenges. (iStock)
An FDA spokesperson released a statement regarding the decision.
“As discussed at the Advisory Committee meeting, there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.”
“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but for the millions of Americans with PTSD.”
Regarding the need for additional treatments for PTSD and other mental health conditions, the agency said it encourages further research and development to “further innovation for psychedelic treatments and other therapies to address these medical needs.”
PharmAla Biotech, a Toronto-based company focused on researching, developing and manufacturing novel derivatives of MDMA, reacted to the decision in a statement sent to Fox News Digital.
“USFDA has an important responsibility to get things right, and we believe that they are acting in good faith. However, there is a vitally important patient need for novel PTSD treatments, which must be balanced with that prudency,” said Nicholas Kadysh, CEO of PharmAla Biotech.
Ecstasy pills (Reuters)
“MDMA is not only supported by a significant evidence base of published clinical trial research, but is also being actively used in patient treatments in two jurisdictions, Canada and Australia, entirely supplied by PharmAla.”
Kadysh added that the company is committed to ongoing research to “convince even the most skeptical regulators that this medicine is both safe and effective.”
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Joe Perekupka, CEO of Freespira, the Washington-based company that makes an FDA-approved digital therapeutic for PTSD and anxiety, also reacted to the decision.
There have not been any new treatment options for PTSD in over two decades, according to a statement from Lykos Therapeutics. (iStock)
“The FDA’s recent decision on MDMA underscores the complex landscape of mental health treatments. At Freespira, we recognize the urgent need for additional effective PTSD treatments, but support the FDA’s commitment to patient safety when reviewing potential new treatments,” he said in a statement to Fox News Digital.
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“We believe in the importance of diverse treatment options and will continue to focus on our mission of democratizing access to advanced mental health care through our patient-centric model.”
Fox News Digital reached out to the FDA and to Lykos Therapeutics requesting comment.
Health
Record-breaking flu numbers reported in New York state, sparking warnings from officials
New flu strain emerging as a severe health threat
Fox News senior medical analyst Dr. Marc Siegel joins ‘America’s Newsroom’ to warn of a new strain of the flu that is spiking hospitalizations across the country and newfound risks of medical marijuana’s link to psychosis.
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The New York State Department of Health reported a record surge in influenza activity, with 71,123 positive flu cases recorded statewide during the week ending December 20.
Health officials said the figure represents the highest number of flu cases ever reported in a single week since influenza became a reportable disease in New York in 2004.
State health data show the weekly total reflects a 38% increase from the previous reporting period, signaling a rapidly intensifying flu season.
There have been 189,312 reported positive flu cases so far this season, while influenza-related hospitalizations rose 63% in the most recent week.
FLU BY STATE: WHERE THIS SEASON’S HIGHLY CONTAGIOUS VARIANT IS SPREADING THE MOST
New York reported the highest weekly total of cases ever recorded since influenza became reportable in 2004. (iStock)
“We are seeing the highest number of flu cases ever recorded in a single week in New York state,” Health Commissioner Dr. James McDonald said in a press release.
There have been 189,312 reported flu cases so far this season, with influenza-related hospitalizations increasing 63% in the most recent week. (iStock)
Earlier this month, the department declared influenza prevalent statewide, a designation that requires unvaccinated health care workers to wear masks in patient care settings.
SURGE IN WHOOPING COUGH CASES IN SOUTHERN STATE PROMPTS HEALTH ALERTS
Health officials continue to emphasize that vaccination remains the most effective way to prevent severe illness and hospitalization from influenza.
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New Yorkers who have not yet received a seasonal flu shot are still encouraged to do so, with experts saying vaccination can offer protection even later in the season.
Health officials continue to urge New Yorkers to take preventive steps, including vaccination and staying home when sick, to limit further spread. (iStock)
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To help limit further spread, the department advises individuals experiencing flu-like symptoms — including fever, cough, sore throat, or body aches — to stay home. State health officials also recommend frequent handwashing, using hand sanitizer, and avoiding close contact with sick individuals.
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For those who become ill, officials say antiviral medications are available and are most effective when started within 48 hours of symptom onset.
Health officials also added that people at higher risk for complications should contact a health care provider promptly for evaluation and possible treatment.
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The department noted that flu activity typically peaks in January, meaning case counts could continue to climb in the weeks ahead.
Health
Did holiday stress wreak havoc on your gut? Doctors say 6 simple tips can help
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If the stress of the holidays wreaked havoc on your gut, you’re not alone — 76% of Americans experience gastrointestinal distress during the holiday season, according to a recent national survey from Oshi Health and YouGov.
Digestive problems can be triggered not only by holiday overeating, but also by stress. Financial worries, disrupted routines, fatigue and interpersonal dynamics rank as some of the top causes.
“I see an uptick in psychiatry-related GI issues during the holiday season,” Dr. Claire Brandon, a gastrointestinal psychiatrist based in New York City, told Fox News Digital. “When you are undergoing stress, your body produces more corticotropin-releasing hormones, which sets off a cascade of the inflammatory system.”
GUT IMBALANCE MAY BE DRIVING AMERICA’S FOOD ALLERGY EPIDEMIC, EXPERTS WARN
Stress hormones can act directly on the gut, leading to more digestive distress and pushing the body out of “rest-and-digest mode,” Brandon said.
“Stress activates the sympathetic — fight, flight, freeze — nervous system, which slows digestion,” added Dr. David Clarke, an Oregon-based gastroenterologist and president of the Association for the Treatment of Neuroplastic Symptoms. “That can lead to bloating, cramps, nausea and sometimes abdominal pain.”
Stress often plays a bigger role in digestive issues than overeating alone, experts say. (iStock)
The good news, doctors say, is that a few simple, realistic steps can help reset the digestive system after the holidays.
No. 1: Reset your sleep
Sleep plays a major role in gut health. Research shows that insufficient or disrupted sleep can change the composition and function of the gut microbiome, potentially affecting metabolic and immune factors that influence overall health.
NOT ALL FIBER IS CREATED EQUAL — DOCTORS SHARE WHICH KINDS TRULY SUPPORT LONGEVITY
“When I travel and get derailed, my main focus is to reset my sleep,” Brandon said. She recommends reestablishing wind-down routines like deep breathing and progressive muscle relaxation.
No. 2: Eat balanced, fiber-rich meals
Fiber helps keep digestion moving and supports healthy gut bacteria, which can aid post-holiday recovery, experts say.
“The usual principles for supporting digestion apply here,” said Clarke. “Consuming a balanced diet emphasizing fruits, vegetables, whole grains and legumes; avoiding highly processed foods; and moderating alcohol will keep your gut microbiome happy.”
Digestive symptoms like bloating and discomfort often spike during the holidays due to stress, travel and disrupted routines. (iStock)
No. 3: Stay hydrated
Staying hydrated will also aid digestion, Clarke said, noting that light-colored urine is a good indicator of hydration.
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Traveling can be particularly tough on the gut, experts say, especially during flights where low cabin humidity causes the body to pull water from the bowels, leading to constipation.
Drinking water before, during, and after flights — and limiting alcohol and caffeine — can help counteract dehydration-related digestive slowdowns. Experts also recommend sipping water consistently throughout the day.
No. 4: Resume regular movement
Both doctors agreed that exercise supports digestion and stress regulation, which are both key to gut recovery.
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“Going on walks can be enough to help with this, but if you have space to do more, including some gentle stretching, that can be a huge help,” Brandon advised.
No. 5: Reduce stress gradually
Stress management plays a critical role in gut health, and experts say that small, consistent habits can help ease gastrointestinal symptoms.
Brandon recommends calming the nervous system with breathing or grounding exercises and slowing down at meals.
Light movement can help support digestion and regulate stress, experts say. (iStock)
“If you’re constantly running on fumes, on a layover in the airport, eating high sugar and doing things off your routine, expect a few disruptions with your gut,” she said. “Reframe it as something that you can reset when you get home.”
No. 6: Skip cleanses and detoxes
Clarke says that detoxes and cleanses are not necessary and can actually be harmful. Instead, he recommends sticking to the basics — including hydration, balanced meals, regular sleep and movement.
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Doctors say the gut is designed to recover on its own in response to consistently healthy practices rather than extreme resets.
Experts recommend returning to balanced, fiber-rich meals instead of intense cleanses. (iStock)
While short-lived symptoms can improve within hours and are usually temporary, experts say lingering or worsening issues shouldn’t be ignored.
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“If you are back home and struggling to feel your usual baseline while back on your routine, it’s probably worth checking in with your physician,” Brandon advised.
Health
Exercise affects the heart in a hidden, powerful way by rewiring nerves, study finds
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Regular exercise may do more than strengthen the heart. It could also reprogram the nerves that control how the heart beats, new research has found.
The discovery could eventually help doctors better treat common conditions such as irregular heart rhythms, chest pain, angina and stress-related “broken-heart” syndrome, according to scientists at the University of Bristol in the U.K.
The study, which looked at lab rats trained over 10 weeks, found that moderate exercise does not affect the heart’s nerve control system evenly. Instead, it produces distinct and opposing changes on the left and right sides of the body. a split researchers say has gone largely unnoticed until now.
SIMPLE LIFESTYLE CHANGES COULD SLASH HEART ATTACK RISK FOR MILLIONS, SCIENTISTS REPORT
“The discovery points to a previously hidden left–right pattern in the body’s ‘autopilot’ system that helps run the heart,” Dr. Augusto Coppi, the study’s lead author and a senior lecturer in veterinary anatomy at the University of Bristol, said in a statement.
Regular exercise may “rewire” the nerves that control the heart, the new study found. (iStock)
“This could help explain why some treatments work better on one side than the other and, in the future, help doctors target therapies more precisely and effectively,” Coppi added.
After 10 weeks of aerobic exercise, the researchers examined the animals’ heart control nerves and found left–right differences that did not appear in inactive rats, according to the research published in the journal Autonomic Neuroscience in September.
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On the right side, the nerve hub that sends “go faster” signals to the heart developed many more nerve cells, suggesting increased wiring. On the left side, however, the number of nerve cells did not rise as much. Instead, the existing cells grew significantly larger, indicating a different kind of adaptation.
The findings could help explain why some heart treatments work better on one side than the other. (iStock)
The findings show that exercise reshapes the heart’s nerve control system in a side-specific way rather than affecting both sides equally, the researchers said. Understanding that process could help doctors better target treatments, especially for patients who cannot exercise or whose symptoms persist despite lifestyle changes.
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Researchers compared the nerve clusters, known as the stellate ganglia, to a “dimmer switch” that fine-tunes how strongly the heart is stimulated. That fine-tuning is important because overstimulation of these nerves is linked to chest pain and dangerous heart rhythm problems.
Scientists caution more studies are needed to determine whether the same effects occur in humans. (iStock)
The findings are early stage and based on animal research, however. So, they do not prove the same effects in people. More studies are needed before they could affect patient care.
Researchers say future studies will explore whether similar left–right nerve changes occur in people and whether they could help explain why some heart treatments work better on one side than the other, potentially paving the way for more precise, personalized care for angina and heart rhythm disorders.
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The study was conducted in collaboration with researchers from University College London, the University of São Paulo and the Federal University of São Paulo in Brazil.
Researchers discovered distinct left-right changes in heart-control nerves after 10 weeks of aerobic exercise. (iStock)
The findings add to growing evidence that regular, moderate exercise benefits the heart in ways scientists are beginning to understand better.
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Fox News Digital has reached out to the study authors for comment.
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