FDA Rejects MDMA As PTSD Treatment
California-based Lykos Therapeutics plans to ask the agency to reconsider its decision after concerns were raised about the data surrounding the psychedelic drug's effectiveness. Separately, the FDA gave the go-ahead for an epinephrine nasal spray to treat allergic reactions.
USA Today:
FDA Rejects Psychedelic Drug MDMA For Post-Traumatic Stress Disorder
The Food and Drug Administration on Friday rejected a California drug company's request to market the psychedelic drug MDMA combined with talk therapy as a treatment for post-traumatic stress disorder. The federal drug regulator told San Jose, California-based Lykos Therapeutics it completed a review of the company's application but would not approve MDMA, also known as ecstasy or molly, as a treatment for PTSD. (Alltucker, 8/9)
Stat:
MDMA Papers Retracted Over Data
The journal Psychopharmacology has retracted three papers about MDMA-assisted psychotherapy — right on the heels of the Food and Drug Administration’s rejection of the closely watched treatment for post-traumatic stress disorder. (Keshavan, 8/11)
In other FDA news on 'mushroom microdosing' —
USA Today:
Diamond Shruumz Recall Now Linked To 113 Cases, 42 Hospitalizations
On Thursday, the FDA released the first round of lab results from testing done on different Diamond Shruumz chocolate bars, revealing that some of the products contained prescription or controlled substances and unlisted compounds. The announcement also confirmed that, as of Aug. 2, the total number of reported illnesses linked to the micro-dosing sweets was up to 113 total with 42 hospitalizations and still two potentially associated deaths across 28 states. (Walrath-Holdridge, 8/9)
And the FDA has approved an alternative to EpiPens —
The Washington Post:
FDA Approves First Nasal Spray For Allergic Reactions
The Food and Drug Administration on Friday approved a nasal spray for serious allergic reactions to food, medications and insect stings, marking the first needle-free treatment for such conditions. The epinephrine nasal spray is administered as a single dose in one nostril and will serve as a critical alternative to treating emergency allergic reactions without an injection, the agency said. (Roubein and Gilbert, 8/9)
More pharmaceutical news —
NPR:
Drugs Like Wegovy And Ozempic May Help Prevent Cancer
Drugs like Ozempic, Wegovy and Zepbound have transformed treatment for obesity and diabetes. Now researchers are excited about their potential impact on other conditions, including addiction and sleep apnea — and even cancer. ... In several recent studies, they show early promise in preventing many common cancers — including breast, colon, liver, and ovarian — known to be driven by obesity and excess weight. (Noguchi, 8/12)
The Wall Street Journal:
Eli Lilly Is Gaining On Novo Nordisk In The Obesity Race
Novo Nordisk had a big head start in the race to dominate the weight-loss market. But Eli Lilly is catching up fast. The two companies’ divergent earnings reports this week showed that Indianapolis-based Lilly is moving faster than its Denmark-headquartered counterpart in the race to win the GLP-1 war. (Wainer, 8/9)
CIDRAP:
In Older Adults, Common Oral Antibiotics Linked To Higher Risk Of Serious Skin Reactions
New research shows that commonly prescribed oral antibiotics are tied to increased risk of severe skin reactions in older adults. In a study published yesterday in JAMA, researchers in Toronto looked at two decades worth of data on hospitalizations and emergency department (ED) visits for serious cutaneous adverse drug reactions (cADRs) and found significant associations with the use of sulfonamides, cephalosporins, and other commonly prescribed classes of antibiotics. (Dall, 8/9)
