Current:Home > NewsFDA panel votes against MDMA for PTSD, setting up hurdle to approval-LoTradeCoin
FDA panel votes against MDMA for PTSD, setting up hurdle to approval
View Date:2024-12-24 00:38:25
Potential approval of MDMA to treat post-traumatic stress disorder hit a major hurdle Tuesday, as a panel of the Food and Drug Administration's outside advisers voted against the treatment.
The committee voted nine against, two in favor, on the question of whether there was enough data to show the drug was effective in treating PTSD. The drug, which doctors call midomafetamine, is sold illegally as the street drug ecstasy.
While the FDA is not required to follow the committee's votes, agency officials often follow the panel's feedback. Sometimes drugmakers end up having to run different studies before they resubmit for the FDA's approval.
The agency is expected to decide by Aug. 11 on the current submission by Lykos Therapeutics on trialing MDMA.
- Psychoactive drugs like ketamine, MDMA, mushrooms and LSD are having a moment
During the Psychopharmacologic Drugs Advisory Committee's daylong meeting, panelists questioned gaps in data from studies submitted by drugmaker Lykos Therapeutics. Some members raised concerns about the ways the studies were designed and their results, along with the drugmaker's failure to collect data requested by the FDA.
Panelists also cited data suggesting the treatment may not offer a long-lasting treatment to PTSD, concerns over accusations about therapists abusing patients in the trials while they were under the influence of the drug or cited claims reported by the Institute for Clinical and Economic Review that therapists may have discouraged negative reports by patients, which may have biased results.
Lykos told the committee that it had investigated the accusations and had adjusted its processes to prevent such conduct. The company said it was working with the FDA to draw up training and safeguards that would protect vulnerable patients after approval.
FDA officials declined to answer questions the committee raised about the specific allegations, aside from confirming that inspections "are ongoing" in the wake of the claims. They asked the committee not to factor that into their votes.
"Although we are aware of those reports, we consider them to be unverified at this point until we do our own inspections," the FDA's Dr. Teresa Farchione told the committee.
- In:
- PTSD
- Food and Drug Administration
Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers the Biden administration's public health agencies, including the federal response to infectious disease outbreaks like COVID-19.
TwitterveryGood! (42457)
Related
- New 'Yellowstone' is here: Season 5 Part 2 premiere date, time, where to watch
- Stock market today: Asian shares mixed after Wall Street hits 2023 high
- No. 3 NC State vs. Liberty women’s game interrupted by leaky roof from heavy rain
- Doctor and self-exiled activist Gao Yaojie who exposed the AIDS epidemic in rural China dies at 95
- Investigators believe Wisconsin kayaker faked his own death before fleeing to eastern Europe
- The increasing hazard of black lung disease facing coal miners
- Diamonds in the vacuum cleaner: Paris’ luxury Ritz hotel finds guest’s missing ring
- Mortgage rates are dropping. Is this a good time to buy a house?
- Here's Your First Look at The White Lotus Season 3 With Blackpink’s Lisa and More Stars
- U.S. Lawmakers Confer With World Leaders at COP28
Ranking
- Man is 'not dead anymore' after long battle with IRS, which mistakenly labeled him deceased
- Another Chinese spy balloon? Taiwan says it's spotted one flying over the region
- Real-life Grinch steals Christmas gifts for kids at Toys For Tots Warehouse
- WHO resolution on the Israel-Hamas conflict hopes for 'health as a bridge to peace'
- Ben Foster Files for Divorce From Laura Prepon After 6 Years of Marriage
- Asia lags behind pre-pandemic levels of food security, UN food agency says
- Krispy Kreme reveals 'Elf' collection before 'Day of the Dozens' deal: How to get a $1 box
- Russian presidential hopeful vows to champion peace, women and a ‘humane’ country
Recommendation
-
Inside Dream Kardashian's Sporty 8th Birthday Party
-
6 teens convicted over their roles in teacher's beheading in France
-
Polling centers open in Egypt’s presidential elections
-
Kishida promises he’ll take appropriate steps ahead of a Cabinet shuffle to tackle a party scandal
-
Tennessee suspect in dozens of rapes is convicted of producing images of child sex abuse
-
Vermont Sheriff’s Association calls for sheriff who kicked shackled prisoner to resign
-
At least 3 killed after fire in hospital near Rome
-
WHO resolution on the Israel-Hamas conflict hopes for 'health as a bridge to peace'