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

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

Axios

The Food and Drug Administration on Friday rejected a controversial treatment for post-traumatic stress disorder that combines ecstasy with psychotherapy. Why it matters: The decision is a major blow to psychedelic therapy advocates and investors, who pressed for the MDMA-assisted therapy to become the first psychedelic treatment approved for clinical use in the United States.

FDA rejects ecstasy treatment for PTSD

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

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

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

Findings of a newly published study show what authors describe as a “cannabis paradox”: Despite concerns that marijuana use may be associated with some heart problems, adults admitted to the hospital after suffering heart attacks actually seemed to fare better if they were cannabis consumers. “The findings of...

Marijuana Users Have Better Outcomes Following Heart Attacks, New Study Finds, Pointing To ‘Cannabis Paradox’

Medtronic said Monday it received Food and Drug Administration approval for deep brain stimulation (DBS) technology that is implanted while the patient is under general anesthetic. Surgeons traditionally perform DBS procedures, a treatment for medical conditions like epilepsy and Parkinson’s disease, while the patient is awake. However, a series of...

Medtronic wins FDA approval for asleep deep brain stimulation

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.

community_voice

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

Two recent developments in Alzheimer’s disease research offer new hope for patients living with the disease, and their families. Among those, in June, Tiziana Life Sciences received Food and Drug Administration clearance to use intranasal foralumab in its first patient with moderate Alzheimer’s disease under the FDA’s expanded access investigational new drug program.

FDA clears nasal spray for moderate Alzheimer’s disease in first patient

TikTok has been sending inaccurate and misleading news-style alerts to users’ phones, including a false claim about Taylor Swift and a weeks-old disaster warning, intensifying fears about the spread of misinformation on the popular video-sharing platform. Among alerts seen by the Financial Times was a warning about a tsunami...

Push alerts from TikTok include fake news, expired tsunami warning

Among patients with fibromyalgia, there was a moderate negative correlation between vitamin D and physical functioning as well as between magnesium and stiffness. An exploratory study evaluating the link between specific micronutrients and the symptoms of fibromyalgia revealed vitamin D and magnesium played a role in physical function and stiffness among patients.1.

Vitamin D, Magnesium Deficiency Linked to Worse Fibromyalgia Symptoms

TMS has been found to be effective for treating clinical depression and other conditions. Prior data and clinical experience suggest that TMS may be more effective than ongoing medication management. Recent work comparing medication and TMS finds that TMS is more effective than multiple medication changes. Transcranial magnetic stimulation (TMS,...

TMS Outperforms Medication in Study of Treatment-Resistant Depression

A study published in Medical Cannabis and Cannabinoids indicated that patients reported a decrease in refractory gastrointestinal (GI) problems following the use of cannabis products. Some of the formulations included cannabis extracts and flower. A team of researchers associated with Thomas Jefferson University evaluated the effects of medical cannabis on...

Study Shows Cannabinoid Products Improve Gastrointestinal Symptoms

Reuters

(Reuters) -Ascendis Pharma said on Monday the U.S. Food & Drug Administration had approved its therapy to treat adult patients with a hormone disorder, sending the Danish drugmaker's shares more than 10% higher in premarket trading.

Ascendis Pharma's hormone disorder therapy gets US approval

The great white shark (Carcharodon carcharias) is a swift and mighty hunter, capable of reaching speeds as high as 6.7 m/s when breaching, although it prefers to swim at slower speeds for migration and while waiting for prey. A team of Japanese researchers has studied the structure of the great white's skin to learn more about how these creatures adapt so well to a wide range of speeds. Their findings could lead to more efficient aircraft and boats with greatly reduced drag, according to a recent paper published in the Journal of the Royal Society Interface.

Studying the skin of the great white shark could help reduce drag in aircraft

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases. This article was originally published on The Center for Biosimilars®. Sandoz secured another approval, this time for an aflibercept biosimilar.1 Enzeevu (aflibercept-abzv) is the fourth...

FDA Approves Biosimilar Enzeevu for Eye Conditions

Mississippi State

A federal appeals court ruled on Friday that geofence warrants, which are used to identify all users or devices in a geographic area, are prohibited by the Fourth Amendment's protection against unreasonable searches. The ruling was issued by the US Court of Appeals for the 5th Circuit, which is generally...

5th Circuit rules geofence warrants illegal in win for phone users’ privacy

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

The FDA has a 60-day filing review period to determine whether the NDA submission is complete and acceptable for review. LENZ Therapeutics Inc announced that the Company has submitted a New Drug Application (NDA) to the FDA for LNZ100 for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States.

LENZ Therapeutics announces submission of New Drug Application to FDA for LNZ100 for treatment of presbyopia

NewsBreak

MDMA for PTSD: Three studies retracted on heels of FDA rejection

A scientific journal has retracted three studies underpinning the clinical development of MDMA—aka ecstasy—as a psychedelic treatment for post-traumatic stress disorder. The move came just a...

MDMA for PTSD: Three studies retracted on heels of FDA rejection

Comments / 0