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.
MARINE VET TOUTS BENEFITS OF PSYCHEDELIC-ASSISTED PTSD DRUGS AS FDA CONSIDERS MDMA APPROVAL
“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.
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The latest COVID-19 vaccine (2024-2025) has been linked to fewer serious heart-related events among U.S. veterans.
New research confirmed a small reduction in COVID-related cardiovascular events, or COVID-19-associated MACE, due to the vaccine.
MACE (major adverse cardiovascular events) is a composite measure of serious heart-related outcomes. It typically includes cardiovascular death, heart attack and stroke, and may also include hospitalization for heart failure.
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Using health records from the U.S. Department of Veterans Affairs, the researchers compared two groups of veterans — one that received the COVID and flu vaccine on the same day (nearly 350,000 people) and another group that received only the flu vaccine (nearly 700,000 people).
For people older than 75, vaccine effectiveness against COVID-associated MACE was 50.7%. (iStock)
Out of more than one million veterans studied, the average age was about 70 and 92% were male, according to a press release.
Within about eight months, the results showed that those who received the 2024-2025 COVID vaccine had a lower risk of COVID-associated major cardiovascular events, with a relative vaccine effectiveness of 37.7%.
The COVID vaccine was linked to a 57.9% lower risk of cardiovascular death, 38.5% lower risk of heart attack and 41.9% lower risk of hospitalization for heart failure, the researchers stated. The result for stroke was not statistically significant.
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The benefit was greatest among adults ages 75 and older and those with underlying health conditions. In people over 75, the vaccine was 50.7% effective at preventing COVID-associated MACE.
As the study was observational, it could not prove cause and effect between the COVID-19 vaccine and lower risk of cardiovascular events, but only highlighted an association.
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Dr. Glenn Hirsch, cardiologist at National Jewish Health in Denver, Colorado, called these results “not overall surprising” in an interview with Fox News Digital.
After eight months, those who received the 2024-2025 COVID vaccine had a lower risk of COVID-associated major cardiovascular events. (iStock)
“This result is consistent with previous studies of the COVID-19 vaccine and other vaccines against infectious diseases [in] preventing cardiovascular events, including heart attack, cardiovascular cause of death or hospitalizations,” he said.
Acute inflammation in the body from infections like COVID-19 increases the risk of cardiovascular events and can cause further complications, according to the doctor.
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“This can lead to a higher risk of blood clotting, but can also make arterial plaques susceptible to rupture, which then leads to clot formation to heal a ruptured plaque,” he said. “This clotting can cause a near-total or complete occlusion of an artery, leading to these cardiovascular events.”
“Vaccines either prevent infection or reduce the severity of infection and subsequent inflammation, lowering the cardiovascular risk.”
Acute inflammation in the body from infections like COVID-19 can increase the risk of cardiovascular events, the study suggests. (iStock)
Despite the positive outcome, the overall benefit of the vaccine in this study was less than in previous studies, according to Hirsch, who was not involved in the research.
This could be due to the lower severity of illness seen in more recent COVID-19 variants, as well as immunity from prior infections among unvaccinated people, he noted. There has also been a decline in COVID testing, making it more difficult to link cardiovascular events to the virus.
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“The bottom line [is] that there is still evidence of benefit from COVID-19 vaccination like many other infectious disease vaccinations, and people should be encouraged to discuss these with their healthcare team annually,” Hirsch advised.
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“This is an observational trial and there can always be some confounding after necessary statistical adjustments and other potential benefits or harms, including adverse effects from vaccines that were not investigated in this study,” he added.
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A former “Real Housewives of Beverly Hills” star is speaking out about a fresh wave of health issues.
Brandi Glanville, 53, has been speaking publicly about ongoing swelling, lumps and paralysis of her face since 2023.
At the time, the reality star shared that she believed she had been infected with a parasite during a trip to Morocco, Fox News Digital previously reported.
BRANDI GLANVILLE SPENDING ‘ALL OF MY MONEY’ LOOKING FOR ANSWERS TO MYSTERY ILLNESS THAT LEFT HER DISFIGURED
After the initial diagnosis, she suspected she contracted a parasite in Morocco and said she could feel it moving within her face.
Brandi Glanville attends the grand opening of Beverly Hills Rejuvenation Clinic West Hollywood in West Hollywood, Calif., on April 25, 2024. (Paul Archuleta/Getty Images)
Glanville was first diagnosed with stress-induced angioedema, a sudden swelling of the deeper layers of the skin and mucous membranes, according to Cleveland Clinic.
Angioedema “is a reaction similar to hives that affects deeper layers of the skin. It can appear with hives or alone,” Mayo Clinic states.
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Most recently, in a June 18 episode of her podcast “Brandi Glanville Unfiltered,” Glanville revealed that doctors discovered a “benign tumor” in one of her facial lymph nodes.
The reality star, who has previously speculated that a parasite may be contributing to her facial symptoms, said the finding could help explain the swelling and fluid buildup she has experienced and noted that she has had a lump in her face for “years.”
Brandi Glanville, 53, has been speaking publicly about ongoing swelling, lumps and paralysis of her face since 2023. (Mega/GC Images)
“I don’t know what’s wrong with me, guys. I thought I was fixed, and then it happened again and now it’s sinking in again,” Glanville said in another June podcast.
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“It could be why the fluid is going around my face and why I’m having a hard time,” she added.
While benign tumors of the face have been known to arise from fat tissue, blood vessels, skin structures, salivary glands or lymphatic tissue, Glanville has not publicly disclosed the specific type of diagnosis she received.
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Prior to learning of the tumor, Glanville said she saw dozens of doctors and spent over $100,000 trying to pinpoint the source of the issue.
Brandi Glanville shares images of painful facial burns caused by Nair hair removal cream in a viral TikTok video. (Brandi Glanville/TikTok)
The reality star emphasized that the tumor is “not cancerous.”
“I haven’t had a face lift yet!” she added.
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Glanville also said she suspected her ruptured breast implants could have played a role in her health issues, claiming the leaking silicone had clogged her lymph nodes.
Fox News Digital reached out to Glanville for comment.
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