A company seeking to treat post-traumatic stress disorder with a combination of MDMA and talk therapy just suffered a major setback from the U.S. Food and Drug Administration. Lykos Therapeutics, the firm aiming for FDA approval, said on Friday that it received a rejection letter from the agency, which called for more research into the potential treatment’s safety and efficacy. Lykos said in response that it wants the FDA to reconsider the decision, adding that it will request a meeting to “further discuss the agency’s recommendations for a resubmission.” MDMA, also known as molly and ecstasy, is a lab-made drug developed more than a century ago by a chemist at the German pharmaceutical giant Merck.

FDA Holds Back MDMA Psychedelic Therapy Over Safety, Efficacy Concerns

UPI News

The U.S. Food and Drug Administration is not approving an application from Lykos Therapeutics for its use of MDMA to treat post-traumatic stress disorder.

FDA rejects MDMA to treat post-traumatic stress disorder

CBS San Francisco

The Food and Drug Administration declined Friday to approve an application to treat post-traumatic stress disorder using the drug midomafetamine, also known as MDMA or the street drug ecstasy, citing "significant limitations" with the data submitted to the agency.Drugmaker Lykos Therapeutics had asked the FDA to approve its MDMA capsules as part of a therapy regimen they argued could be a breakthrough for treating challenging cases of PTSD. Lykos said the FDA asked for another phase 3 trial to study the safety and efficacy of MDMA. "The FDA request for another study is deeply disappointing, not just for all those who dedicated...

FDA rejects MDMA for treating PTSD, calls for redo of study, drugmaker says

A new scientific review examining the potential therapeutic effects of cannabis-based medicine on Tourette syndrome finds that medical marijuana shows “promising and potentially effective outcomes…in mitigating the severity of tics and premonitory urges.”. Authors of the literature review, published last month in the European Journal of Clinical Pharmacology,...

Medical Marijuana Is A ‘Promising’ Treatment For Tourette Syndrome, New Scientific Review Concludes

Apple Valley News Now

WASHINGTON — Federal health regulators on Friday declined to approve the psychedelic drug MDMA as a therapy for PTSD, a major setback for groups seeking a breakthrough decision in favor of using mind-altering substances to treat serious mental health conditions.

FDA rejects psychedelic MDMA as treatment for PTSD, calling for additional study

In this study, 49.5 percent of participants had taken a benzodiazepine at some point over the past 15 years. After a follow-up interval averaging 11.2 years, 13.3 percent had developed dementia. The researchers conclude, “Overall use of benzodiazepines is not associated with increased dementia risk.”. They also find, separately,...

Long-Term Use of Benzodiazepines and Dementia Risk

shefinds

Parkinson’s disease is a progressive neurodegenerative disorder that affects millions of people worldwide. Characterized by tremors, stiffness, and difficulty with balance and coordination, the disease is primarily caused by the loss of dopamine-prod...

3 Supplements A Neuroscientist Swears By To Prevent Parkinson’s Disease: ‘Gives Your Brain The Raw Materials To Repair Itself’

There’s currently no cure for epilepsy. While medications can limit or eliminate seizures in many people, sometimes epilepsy doesn’t respond to medications. Understanding the mechanisms behind epilepsy can help researchers develop more effective medications and surgery. Epilepsy is a brain disorder that causes recurring seizures. During a seizure,...

Is it Possible to Cure Epilepsy?

The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Longeveron’s experimental cell therapy Lomecel-B for mild Alzheimer’s disease. The designation is designed to accelerate the development and review processes for regenerative medicine candidates, including cell therapies, intended to treat, modify, reverse,...

Lomecel-B granted FDA RMAT status for mild Alzheimer’s

A pharmacist explains the nuances between these two popular prescription sleep aids. Lunesta (eszopiclone) and Ambien (zolpidem) are prescription medications commonly used to treat insomnia (difficulty sleeping). This article covers the differences between these medications, their effectiveness, and important safety information. FDA Warning. Ambien and Lunesta have a black box...

Lunesta vs Ambien: Which Is Better?

Topamax (topiramate) is a brand-name drug that’s prescribed to help prevent migraine headaches. This article covers topics such as side effects, dosage, and how Topamax works. Topamax is available in these forms: oral tablets and sprinkle capsules. Topamax belongs to a drug class called anticonvulsants. The medication is available...

Topamax for migraine

Community Voices represent independent, third-party users who have joined our contributor program but not yet verified their accounts. Community Voices are expected, like all users, to adhere to our Community Standards.

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NewsNinja

A lady is cautioning others about purchasing budget earrings from Amazon, Shein, and H&M, after she experienced keloid formations on her earlobes due to wearing them. On a TikTok post that has garnered more than 334,000 likes, Sailor Rozema (@sailor.rozema), a content creator, shares a warning with her community of "dangly earring girls": the inexpensive jewelry found in fast fashion can have negative impacts on your well-being.

‘I’ll never be wearing earrings for the rest of my life’: Customer warns against buying from Shein

Crexont kept symptoms at bay for an extra 30 minutes a day when compared with other Parkinson’s drugs. Amneal Pharmaceuticals Inc. announced yesterday the FDA approval for Parkinson’s drug Crexont (carbidopa and levodopa) via a news release on their website. This novel medication, formerly known as IPX203, combines two common drugs into one capsule.

FDA Approval Granted for Novel Parkinson’s Treatment

New research suggests that CBD products may not alleviate chronic pain and could be both a financial burden and a potential health risk. New research led by the University of Bath in the UK suggests that CBD products, despite their popularity as an alternative pain treatment, do not alleviate chronic pain and may be both a financial drain and a health risk. CBD, or cannabidiol, is a chemical naturally found in the cannabis plant and is commonly sold in various forms such as oils, tinctures, vapes, topical creams, edibles like gummy bears, and soft drinks, available in stores and online.

A Waste of Money: New Study Reveals That CBD Is Ineffective for Pain Relief

Florida State

Contributors represent independent, third-party users who have joined our contributor program and self-verified their accounts. They have also demonstrated their experience writing hard news for other outlets. Contributors are expected, like all users, to adhere to our Community Standards.

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Jacksonville Today

Republican Donald Trump has a 7-point lead over Democrat Kamala Harris among Florida voters, 49% to 42%, according to a new poll from the University of North Florida. Four percent are backing another candidate, and 6% are undecided or didn’t answer.

New Florida poll: Trump leads; support strong for abortion and recreational weed

The Lens

This year’s area of low oxygen in the Gulf of Mexico is larger than average, the National Oceanic and Atmospheric Administration (NOAA) announced on Thursday. The “dead zone” is approximately 6,705 square miles , as measured last week. Within NOAA’s 38 years of measuring the dead zone, this year’s assessment marks the 12th-largest area of low to no oxygen, which can kill fish and marine life.

Gulf ‘dead zone’ larger than average, larger than expected for 2024, scientists announce

A recent study published in the International Journal of Geriatric Psychiatry reveals a significant link between depression and an increased risk of developing dementia. Conducted over 15 years, the study found that people with depression at the start of the study were 74% more likely to develop dementia than those without depression. Additionally, the onset of dementia occurred about two years earlier in individuals with depression. These findings underscore the importance of early detection and treatment of depression to potentially prevent future cognitive decline.

This common mental health condition increases the risk of dementia by 74%, study finds

Colorado State

David Heitz

A bill quietly introduced this spring in the Colorado legislature to decriminalize the possession of drug paraphernalia obtained by harm reductionists has become law. As low-key as the legislation was introduced, the bill was signed into law without fanfare June 6. It garnered little to no media attention.

Colorado legalizes needles, pipes for meth and crack if obtained by harm reduction group

The Marijuana Herald

The Marijuana Herald - Marijuana news and information
In 2024, a growing body of research has highlighted the potential therapeutic benefits of psilocybin, the psychedelic compound found in “magic mushrooms”. These studies, published in various peer-reviewed journals, have explored psilocybin’s effects on mental health conditions such as depression, anxiety, obsessive-compulsive disorder (OCD), and even Alzheimer’s disease, among other ailments. With that in mind, … 
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The post 10 Important Psilocybin (Magic Mushroom) Studies Published in 2024 appeared first on The Marijuana Herald.

10 Important Psilocybin (Magic Mushroom) Studies Published in 2024

Georgia State

Atlanta, GA

Daily Coffee Press

A 40-year-old man has been sentenced to over 28 years in prison for distributing significant amounts of fentanyl and other controlled substances to dealers in the Middle Georgia region. Authorities revealed that investigators uncovered evidence linking the drugs provided by the defendant, 40-year-old Lagary Williams, also known as "Frog," from Atlanta, to a fatal overdose.

Atlanta Man Sentenced to 28 Years for Supplying Deadly Fentanyl Linked to Fatal Overdose

NewsBreak

The MDMA therapy movement is having a rough trip

What’s worse than a rejection? Two rejections, back to back. Fresh off a thumbs-down from the FDA, the psychedelic therapies company Lykos Therapeutics says it’ll challenge...

The MDMA therapy movement is having a rough trip

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