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FDA rejects MDMA as psychedelic-based treatment for mental health, PTSD

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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.

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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.” 

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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 for the millions of Americans with PTSD.”

— Lykos Therapeutics

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. 

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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.

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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.

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Doctor reveals what 30 days without alcohol does to the brain and body amid Dry January

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Doctor reveals what 30 days without alcohol does to the brain and body amid Dry January

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After a season of bingeing and drinking, your body may feel like it needs a break from the party.

Dry January — a modern trend that challenges people to abstain from drinking for the first month of the year — has become a popular way to “detox” from the holidays and start the new year on a healthy note.

Research has linked alcohol to a variety of health conditions, ranging from hangovers to higher cancer risk.

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In a recent podcast episode of “The Dr. Mark Hyman Show,” Dr. Mark Hyman, chief medical officer of Function Health, shared how 30 days of not drinking alcohol can transform health.

Hyman, who is based in Massachusetts, called Dry January a “powerful way to see in real time how alcohol affects nearly every system of your body and how quickly those systems can recover.”

Dry January has become a popular way to “detox” from the holidays and start the new year on a healthy note. (iStock)

Alcohol’s toll on the brain and body

Hyman acknowledged that most people drink to feel happier and more comfortable in social situations. This effect is caused by the main ingredient in alcohol, called ethanol, which can also have toxic effects.

Instead of stimulating the brain, alcohol slows it down and loosens inhibitions. “You feel more relaxed, more social, more confident, maybe you feel a little euphoric,” Hyman said.

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Alcohol’s effect on the brain can also lead to poorer decisions and slower reflexes, the doctor cautioned.

Drinking alcohol can cause cognitive decline and brain fog, experts warn. (iStock)

Drinking also impacts the prefrontal cortex of the brain, which Hyman described as “the adult in the room,” responsible for judgment, planning and restraint. “It goes offline early in drinking, which explains why people feel freer or act impulsively when they drink,” he said.

Even moderate drinking can cause metabolic stress, inflammation, impaired detoxification and hormonal shifts, Hyman said, which can impact nearly every organ system in the body.

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Alcohol consumption has also been linked to an increased risk of cancer, metabolic dysfunction, gut microbiome disturbances and mitochondrial toxins.

It can also prevent the body from falling into REM sleep, which is the deep rest recovery period when the immune system cleans out the day’s toxins, according to Hyman.

Alcohol can impact deep rest and mental health, according to experts. (iStock)

Memory loss, cognitive decline, anxiety, sleep disruption, dementia and cardiovascular disease are all known risks of long-term alcohol use, as well as liver complications like fatty liver disease.

“Bottom line, alcohol taxes every major system in your body, especially your liver, your brain, your gut, your hormones,” Hyman said.

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The effects of 30 days with no alcohol

The first week after your last drink, the body begins to detoxify and reset, according to Hyman. Blood sugar and cortisol stress hormones level out, and the liver begins to process a “backlog of toxins.” The body also re-hydrates and re-energizes.

The first 30 days with no alcohol allows the body to balance itself out. (iStock)

The second week, the gut and brain will begin to re-balance, as hormones like serotonin and dopamine stabilize, gut inflammation drops and the microbiome begins to heal. Cravings for sugar and alcohol will wane and mental clarity returns, the doctor said.

Week three is marked by further decreases in inflammation, fatty liver and blood pressure. This can be noticeable in the skin, as puffiness and redness are reduced. Mood also begins to stabilize, with lower anxiety levels.

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In week four, the body experiences additional metabolic and immune benefits, Hyman shared, including more insulin sensitivity, which makes it easier to lose weight.

“You have a stronger immune response. You’re not getting sick as much. You have better deep sleep, balanced hormones, especially cortisol and testosterone,” he said. “And you see a big change in energy, confidence and focus.”

Abstaining from alcohol can help restore energy, according to experts. (iStock)

Dr. Pinchieh Chiang, a clinician at Circle Medical in San Francisco, said that Dry January isn’t a “detox,” but rather provides “feedback” from the body.

“It gives the body time to show people how it feels without alcohol. For many, that insight alone changes their relationship with drinking,” she said. “The biggest surprise isn’t what people give up, it’s how much better they feel.”

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HIGHER STROKE RISK LINKED TO CONSUMING CERTAIN AMOUNT OF ALCOHOL, STUDY FINDS

The doctor confirmed that the first few days of not drinking may feel harder than expected, sometimes causing restlessness, cravings or disrupted sleep, but Dry January can ultimately change drinking habits for the remainder of the year.

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After a full year without alcohol, Chiang noted that health improvements are more profound. “We see sustained improvements in blood pressure, liver function and inflammation,” she said. “Those changes directly affect long-term heart disease and stroke risk.”

The risks of ‘all or nothing’

Some experts warn that adopting the Dry January trend could strengthen the urge to drink more in the other months, noting that some drinkers may find more success by slowly consuming fewer drinks per week.

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Thomas Stopka, Ph.D., an epidemiologist and professor in the public health and community medicine department at Tufts University School of Medicine in Massachusetts, shared in a Futurity report that for some people, “damp January” may be more suitable.

One expert warned that not all drinkers should quit “cold turkey,” as it could lead to severe withdrawals. (iStock)

“Dry January is well-intentioned, and it may work really well for the people who can stick to it, maybe even beyond January,” he said. “Other people may be more inclined to cut down on alcohol consumption rather than quit drinking completely for the month.”

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Stopka noted that successful harm-reduction approaches “aim to be judgment free.”

“Substance use disorder is a disease,” he said. “It takes time to treat the disease and to stay connected to the continuum of care — from prevention to treatment initiation to sustained therapy, whether through medication, self-help, or individual therapy or group support.”

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Those struggling with signs of alcohol use disorder should consult a medical professional for personalized guidance.

Fox News Digital reached out to several alcohol industry associations requesting comment.

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The Best Weight Loss Medications and Supplements in 2026

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