World

US FDA staff raises concerns over data from MDMA-based PTSD therapy

2024.05.31 12:25

By Pratik Jain and Sriparna Roy

(Reuters) -The U.S. health regulator’s staff said on Friday data on the psychedelic drug MDMA for post-traumatic stress disorder was difficult to interpret, and raised new safety concerns ahead of a meeting of the agency’s advisers.

The comments set the stage for discussions over the therapy’s benefits and risks by the U.S. Food and Drug Administration’s advisory panel on Tuesday, as the agency reviews the therapeutic use of the drug for the first time.

The FDA is seeking recommendations from its advisers on a capsule version of MDMA made by Lykos Therapeutics, formerly known as MAPS Public Benefit Corp. The agency is not obligated to follow the advisers’ recommendations, but it usually does.

Chief among the reviewer’s concerns was that patients in the drug’s trials were aware of whether they were given MDMA or a placebo due to its psychedelic effects, clouding how well the drug worked.

There, however, is a large unmet need for new treatments for PTSD, which affects those who have experienced traumatic events and is common among war veterans, as existing drugs do not work on all patients.

“Although this application presents a number of complex review issues, it does include two positive studies,” the FDA staff said.

MDMA is currently illegal in the U.S. and the FDA has so far never approved the therapeutic use of the mind-altering drug, commonly called ecstasy or molly.

If approved, it would mark a watershed moment for psychedelic researchers who say drugs like MDMA can treat mental health disorders and have therapeutic applications beyond their illicit use.

The FDA staff said if the drug was approved, it would require Lykos to collect more lab safety data, including liver function tests after cases of liver toxicity were seen in the therapy’s trials.

© Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Lykos studied the party drug in a total of 194 patients across two late-stage studies, which comprised three treatment cycles — each consisting of one medication session and three sessions of talk therapy alone — under the supervision of a healthcare provider.

Patients who received doses of MDMA in addition to therapy sessions showed a significant reduction in symptoms of PTSD, compared to placebo, as assessed by a structured interview meant to measure severity of the symptoms.



Source link

Related Articles

Back to top button
bitcoin
Bitcoin (BTC) $ 96,848.95 2.03%
ethereum
Ethereum (ETH) $ 3,299.51 4.88%
tether
Tether (USDT) $ 1.00 0.11%
solana
Solana (SOL) $ 245.64 5.94%
bnb
BNB (BNB) $ 645.37 4.26%
xrp
XRP (XRP) $ 1.35 13.87%
dogecoin
Dogecoin (DOGE) $ 0.409168 12.10%
usd-coin
USDC (USDC) $ 0.999454 0.17%
cardano
Cardano (ADA) $ 0.980725 11.59%
staked-ether
Lido Staked Ether (STETH) $ 3,301.87 4.69%
tron
TRON (TRX) $ 0.20328 8.50%
avalanche-2
Avalanche (AVAX) $ 39.66 7.38%
stellar
Stellar (XLM) $ 0.50839 10.41%
the-open-network
Toncoin (TON) $ 5.95 2.13%
shiba-inu
Shiba Inu (SHIB) $ 0.000025 10.34%
wrapped-steth
Wrapped stETH (WSTETH) $ 3,930.31 3.99%
wrapped-bitcoin
Wrapped Bitcoin (WBTC) $ 96,565.87 1.53%
polkadot
Polkadot (DOT) $ 8.59 5.00%
chainlink
Chainlink (LINK) $ 16.52 5.70%
bitcoin-cash
Bitcoin Cash (BCH) $ 487.71 10.00%
weth
WETH (WETH) $ 3,297.03 4.89%
sui
Sui (SUI) $ 3.25 10.44%
pepe
Pepe (PEPE) $ 0.000019 11.66%
leo-token
LEO Token (LEO) $ 8.71 0.92%
near
NEAR Protocol (NEAR) $ 6.25 2.13%
litecoin
Litecoin (LTC) $ 94.04 8.79%
aptos
Aptos (APT) $ 11.82 8.76%
uniswap
Uniswap (UNI) $ 10.34 4.06%
wrapped-eeth
Wrapped eETH (WEETH) $ 3,491.15 3.88%
hedera-hashgraph
Hedera (HBAR) $ 0.140704 6.79%
usds
USDS (USDS) $ 1.00 0.08%
internet-computer
Internet Computer (ICP) $ 10.68 7.92%
crypto-com-chain
Cronos (CRO) $ 0.184032 9.63%
polygon-ecosystem-token
POL (ex-MATIC) (POL) $ 0.537201 6.85%
ethereum-classic
Ethereum Classic (ETC) $ 27.72 9.67%
ethena-usde
Ethena USDe (USDE) $ 1.00 0.20%
render-token
Render (RENDER) $ 7.38 7.48%
kaspa
Kaspa (KAS) $ 0.147474 8.41%
fetch-ai
Artificial Superintelligence Alliance (FET) $ 1.43 0.47%
bittensor
Bittensor (TAO) $ 495.29 8.56%
whitebit
WhiteBIT Coin (WBT) $ 24.40 1.22%
dai
Dai (DAI) $ 0.999886 0.19%
celestia
Celestia (TIA) $ 7.90 22.86%
arbitrum
Arbitrum (ARB) $ 0.813741 6.79%
bonk
Bonk (BONK) $ 0.000044 14.34%
mantra-dao
MANTRA (OM) $ 3.66 3.82%
cosmos
Cosmos Hub (ATOM) $ 8.36 2.04%
vechain
VeChain (VET) $ 0.040189 8.61%
filecoin
Filecoin (FIL) $ 5.35 0.88%
okb
OKB (OKB) $ 52.51 2.30%