FDA 顾问拒绝 MDMA 治疗 PTSD 后,迷幻药股票遭受重创
Psychedelic Stocks Hit With Bad Trip After FDA Advisers Reject MDMA Treatment For PTSD

原始链接: https://www.zerohedge.com/medical/psychedelic-stocks-hit-bad-trip-after-fda-advisers-reject-mdma-treatment-ptsd

美国食品和药物管理局 (FDA) 顾问在会议期间拒绝使用 MDMA(一种通常称为摇头丸或莫莉的精神活性物质)来治疗创伤后应激障碍 (PTSD)。 进行了两次单独的投票; 一个是关于它的功效,另一个是关于它的风险回报平衡。 他们以 9 比 2 的优势发现 MDMA 与谈话疗法相结合对 PTSD 患者无效。 在安全方面,委员会以 10 比 1 的投票结果反对该方案的好处大于风险。 这些投票标志着 FDA 小组首次考虑将附表 I 迷幻化合物用于医疗用途。 超过 1300 万美国人,包括退伍军人,患有这种精神疾病,因此新的治疗方法至关重要。 小组成员指出了对相互矛盾的数据、未解决的问题以及支持制药商 Lykos Pharmaceuticals 提出的 MDMA 治疗方法的证据不足的担忧。 对可能的研究违规行为的指控使事情变得更加复杂。 尽管存在这些障碍,加州大学洛杉矶分校的精神病学家 Walter Dunn 博士还是支持 MDMA,因为研究显示了有希望的治疗结果。 在做出不利决定后,Mind Medicine、Compass Pathways 和 Atai Life Sciences 的股价大幅下跌。 Jeffries 分析师 Andrew Tsai 表示,与预期相反,委员会对 Lykos 的外消旋 MDMA 投了反对票,该药物证明了治疗 PTSD 的足够数据。 Lykos 的试验与正在进行的迷幻药项目之间的不同方面导致人们对迷幻药的批准性更加怀疑。

相关文章

原文

Psychedelic stocks were battered in premarket trading after a panel of experts advising the Food and Drug Administration rejected the approval of MDMA for post-traumatic (PTSD) stress disorder. 

There were two votes - one for MDMA's efficacy and another for safety, by the FDA's Psychopharmacologic Drugs Advisory Committee. They voted 9-2 that MDMA – with talk therapy – is not effective for treating PTSD. The second vote was 10-1 that the benefits of MDMA treatment don't outweigh its risks. 

This was the first time FDA advisers have considered a Schedule I psychedelic for medical treatment. Also, there has not been a new treatment for PTSD in over two decades, as more than 13 million Americans, many of who are veterans, suffer from the mental disorder. 

The outcome of the two votes reflected panel members' struggle between new PTSD treatments and the clinical data submitted by drugmaker Lykos Pharmaceuticals. They pointed out the data had inconsistencies and unanswered questions and lacked evidence supporting the MDMA treatment used in the therapy sessions.

"It seems like there are so many problems with the data," Melissa Barone, one of the panelists and a psychologist with the VA Maryland Health Care System, told NPR News, adding, "Each one alone might be okay, but when you pile them up on top of each other..."

Several panel members raised concerns about allegations of potential misconduct and bias in the trials, which could have affected the results.

"I have real concerns with the validity of the data and the allegations of misconduct," said Elizabeth Joniak-Grant, a sociologist and a panel member, adding, "I can't in good conscience support something where these many harms are being reported."

However, Dr. Walter Dunn, a psychiatrist at UCLA, was one of the few panelists who voted in favor of MDMA.

Dunn acknowledged the misconduct allegations but added the data showed the treatment could be effective for PTSD. 

In premarket trading, psychedelic stocks were clubbed like a baby seal. Mind Medicine fell 14%, Compass Pathways down 11%, and Atai Life Sciences slid 8%. 

Jefferies analyst Andrew Tsai wrote in a note, "Contrary to our expectation, the FDA AdCom voted negatively on Lykos' racemic MDMA having adequate data to demonstrate effectiveness in PTSD." He pointed out there are differences between Lykos' trial and other psychedelic programs, "we may see some increased uncertainty around the approvability of psychedelics."

联系我们 contact @ memedata.com