Take two Peanut M&Ms and call in the morning. No really. That’s how one study participant is keeping up his peanut resistance after building it up during a clinical trial designed to test the effectiveness of a peanut allergy protection therapy. Two-thirds of the kids enrolled in the study were able to consume about two peanuts themselves whereas previously they had experienced severe, sometimes life-threatening reactions to even trace amounts. But now, “These kids can eat enough peanut that parents no longer will have to worry about their teenage daughter kissing someone who’s eaten peanut butter.” Good—parents have enough things to be worried about when their teenage daughter is kissing someone without including anaphylaxis. The FDA gave the drug breakthrough therapy status, so you could see it on the market around now in 2019.
When diagnosing a mild Traumatic Brain Injury, or concussion, the standard tool is a CT scan pointed at your head. But CT scans are expensive and could expose patients to unnecessary amounts of radiation if nothing shows up in the scan. That’s the problem the first FDA-approved blood test for concussions—the Brain Trauma Indicator—aims to solve. The test identifies elevated levels of two proteins whose presence suggest CT scan-visible damage, essentially providing a pre-screener for the more expensive procedure. The device, produced by Banyan Biomarkers, was approved via the FDA’s Breakthrough Devices Program, which is basically the Breakthrough Therapy Designation’s cousin program. While sports aren’t the only (or most important) application for such a test, the timelines associated with the test are not yet practical for game-time decisions. Results take 3-4 hours to obtain. Antonio Brown, you’re cleared to play—for now.
The party drug known as Molly has been all the rage in popular music recently, but chemists might know it better from its chemical name: methylenedioxy-methylamphetamine or MDMA. MDMA (you may know it as ecstasy if you partied super hard in the 90s). What you might not know about MDMA is that it seems to be an extremely effective way to help treat PTSD. On Tuesday, the FDA gave approval for a Phase III trial, based off previous studies like one that showed two-thirds of patients treated no longer fit the criteria for having PTSD. The researchers have applied for Breakthrough Therapy Designation, and if they succeed, we could see a branded MDMA drug on the market by 2021.
The 1.6 million (just in the US!) sufferers of atopic dermatitis, a type of eczema, will no doubt be thrilled at the results of two Phase III trials released Saturday. The biologic treatment dupilumab was shown to drastically reduce the amount and severity of inflammation caused by the skin condition, with close to 40% of those receiving the drug reporting a complete disappearance of rashes. This is a huge deal, considering the condition seems to be otherwise untreatable. The FDA agrees, and assigned the treatment a Breakthrough Therapy designation in 2014 after positive Phase I and II results, meaning we could see an approval from them as early as March of next year.