MDMA

MDMA-AT would have been the first psychedelic-based therapeutic cleared by the FDA for any condition in the United States and the first PTSD medication to receive approval in 24 years.

🪩 cleared by [ˈklɪəd baɪ] - одобрена кем-то

The rejection is a blow to drug manufacturer Lykos Therapeutics, which sought approval of the therapy based on two pivotal trials that were plagued with criticisms of potential unblinding and investigator bias.

🪩 rejection [rɪˈʤekʃn] - отказ

🪩 a blow [bləʊ] - удар

🪩 seek/sought [siːk]/[sɔːt] - искать/искал

🪩 pivotal [ˈpɪvətl] - основной/ключевой

🪩 to be plagued with [pleɪgd wɪð] - столкнуться с

🪩 unblinding [ʌnˈblaɪndɪŋ] - расслепление, раскрытие сведений

🪩 bias [ˈbaɪəs] - предвзятость

The study evaluated 90 patients with PTSD randomly assigned to receive MDMA 80 mg or 120 mg or placebo […].

Patients could receive a supplemental dose of MDMA after the first dose. The company reported that 82% of patients reported a significant improvement, with more than half saying they no longer had PTSD. […]

However, in June, the FDA's Psychopharmacologic Drugs Advisory Committee voted that the efficacy data was unconvincing. Only one panelist agreed that the benefits outweighed the risk.

🪩 evaluate [ɪˈvæljʊeɪt] - оценивать

🪩 to be assigned [əˈsaɪnd] - быть назначенным

🪩 supplemental [sʌplɪˈmentl] - дополнительный

🪩 a significant improvement [sɪgˈnɪfɪkənt ɪmˈpruːvmənt] - значительное улучшение

🪩 efficacy [ˈefɪkəsɪ] - эффективность

🪩 unconvincing [ʌnkənˈvɪnsɪŋ] - неубедительный

🪩 benefits outweigh the risks [ˈbenɪfɪts aʊtˈweɪ ðə rɪsks]- преимущества перевешивают риски