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.
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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
Common nighttime noise exposure may trigger heart problems, study suggests
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Living near heavy traffic could negatively impact your heart health.
A European study, published in the journal Environmental Research, found that exposure to nighttime road traffic noise is linked to changes in the blood, leading to worsened cholesterol and cardiovascular risks.
The researchers considered data from the U.K. Biobank, Rotterdam Study, and Northern Finland Birth Cohort 1966, including more than 272,000 adults over the age of 30, according to a press release.
Nighttime road noise exposure was estimated at all participants’ homes based on national noise maps. Researchers also took blood samples to measure the participants’ metabolic biomarkers for disease, then mapped the link between nightly noise levels and existence of biomarkers.
Exposure to loud noise was associated with increased concentrations of cholesterol-related biomarkers. (iStock)
The study found that people exposed to louder noise at night — especially sounds above 55 decibels — showed changes in 48 different substances in their blood. Twenty of these associations “remained robust” throughout all cohorts.
Exposure to loud noise was associated with increased concentrations of cholesterol-related biomarkers, especially LDL “bad” cholesterol, IDL (intermediate-density lipoprotein) and unsaturated fatty acids.
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As noise levels increased, starting at around 50 decibels, cholesterol markers rose steadily, the release stated.
The authors concluded that this study “provides evidence that nighttime road traffic noise exposure from 50 dB upward is associated with alterations in blood cholesterol and lipid profiles in adults.”
Researchers noted a link between traffic noise and cardiometabolic disease. (iStock)
Study co-author Yiyan He, doctoral researcher at the University of Oulu in Finland, noted that in this type of research, small effect sizes are expected, and environmental exposures such as traffic noise are “typically modest.”
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“Despite this, we observed statistically robust and consistent associations across many biomarkers, especially those related to LDL and IDL lipoproteins,” she told Fox News Digital.
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“We also identified a clear exposure-response pattern starting at around 50 dB, suggesting that metabolic changes become more evident as noise levels increase.”
This aligns with public health guidance, as the World Health Organization recommends lower nighttime noise limits at around 40 to 45 dB, Yiyan He added.
“This finding may clarify the association between traffic noise and cardiometabolic diseases,” the researchers wrote. (iStock)
“The 55 dB level is often used as an interim benchmark associated with substantial noise annoyance and sleep disturbance,” she said. “In our study, we observed associations not only at 55 dB, but also indications of effects emerging at around 50 dB.”
The strength and consistency of the cholesterol-related associations were surprising, as these changes are usually “subtle.”
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“Instead, we found consistent associations across multiple large European cohorts, which strengthens confidence that the findings may reflect real biological patterns,” Yiyan He went on. “We were also interested to see that effects were minimal below ~50 dB, suggesting a possible threshold-like pattern.”
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The researcher noted that these findings were consistent across genders, education levels and obesity status.
The study was restricted to White Europeans, which posed a limitation. There was also a lack of information on the fasting status in the UK Biobank.
Changes in cholesterol levels were more severe than researchers expected. (iStock)
“Fasting can influence levels of certain metabolites, particularly fatty acids,” Yiyan He said. “However, based on UK Biobank documentation, fewer than 10% of participants were fasting for at least eight hours, and our main findings focused on cholesterol-related biomarkers, which are generally less sensitive to short-term fasting.”
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The researchers also lacked information on bedroom location, indoor noise exposure and time spent at home.
“These factors may introduce non-differential exposure misclassification,” Yiyan He said. “Additionally, noise exposure estimates were based on participants’ temporary residential addresses at the time of blood sampling, without considering the duration of residence.”
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“Many of these limitations would tend to bias results toward the null, so the consistent associations we observed remain noteworthy.”
Experts recommend taking measures to limit traffic noise at night. (iStock)
Based on this latest research, Yiyan He noted that nighttime noise is a “health-relevant exposure,” not just “an annoyance.”
“Our findings suggest that nighttime traffic noise may subtly but consistently affect metabolic health,” she said. “While the changes in cholesterol and lipid levels for any one individual are small, traffic noise affects a very large number of people, which means the potential public health impact could be substantial.”
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The researcher recommends taking measures like improving sound insulation, using noise-reducing strategies and placing bedrooms on the quieter side of the home when possible.
“Because sleep is a key pathway linking noise to health, protecting the nighttime sleep environment is especially important,” she added.
Health
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