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US HEALTH REGULATORS have denied an application for treating post-traumatic stress disorder (PTSD) with the drug MDMA, commonly known as ecstasy, saying more investigation needed to be done.
The company that submitted the application, Lykos Therapeutics, said in a statement that the Food and Drug Administration (FDA) had requested an additional Phase 3 clinical trial to study MDMA’s “safety and efficacy.”
A panel of experts convened by the FDA to evaluate clinical data on MDMA had overwhelmingly voted in early June to say there was insufficient evidence to prove it was effective.
While unsurprising, the decision announced yesterday represents a blow to advocates of the novel treatment.
“The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD… who have not seen any new treatment options in over two decades, said Lykos CEO Amy Emerson.
PTSD is a debilitating mental health condition that develops after a person experiences or is threatened by traumatic events such as death, combat or sexual assault.
It affects an estimated five percent of Americans in any given year.
Pharmaceutical treatment options for PTSD are so far limited to two antidepressants that require three months of dosing to take effect, and response rates to the medications have been found to be uneven.
MDMA — methylenedioxymethamphetamine — is a Schedule 1 drug under the Controlled Substances Act, and approving it for medical use would have represented a major shift.
California-based Lykos based its request for regulatory approval on two clinical studies, each of which enrolled around 100 people, to evaluate MDMA used together with other psychological interventions such as talk therapy, against a placebo with talk therapy.
These two studies, published in the prestigious journal Nature Medicine, indicated MDMA was indeed both safe and highly effective at treating PTSD.
But nine out of 11 experts on the FDA panel said available data was not enough to show the treatment was effective, and 10 out of 11 said the benefits did not outweigh the risks.
In a briefing document put together ahead of the meeting, FDA staff raised concerns about Lykos’s clinical trial methodology and criticized the company for not gathering sufficient side effect data.
The company said it will “work diligently in the coming months to address FDA’s concerns and to take advantage of agency processes to resolve scientific disagreements.”
“We intend to work tirelessly and use all available regulatory pathways to find a reasonable and expeditious path forward,” Emerson added.
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I use this medicine as a treatment for dance music, and I find it helps me deal with it greatly !
@John C: I’d imagine some ganja might be even better.
@ItWasLikeThatWhenIGotHere: they’re opposites really.
Big pharmaceutical being protected again
@Robert Halvey: explain how? Drugs have to go through rigorous testing before being approved. If they get denied it’s usually based on the efficacy of the drug or risk to human life. Do you want drugs going to market that don’t meet regulatory requirements?
@JB Software: Eh, no, they don’t. Most pharmaceuticals are discovered haphazardly, and then they invent an illness to use them to treat unfortunates, with scant benefits for the most part. They don’t even understand why SSRIs happen to alleviate negative symptoms for a minority of users.
@JB Software: The FDA is funded by the companies that need their approval for their smarties. Often, FDA employees get a nice new gig with the aforementioned companies suspiciously soon after products are green-lit.
@Pól Pot: Pharmaceutical companies now invent illness?. Wow I thought I heard crazy before what you just said is a whole new level of crazy. Give me 3 examples of illnesses that pharmaceutical companies have invented to sell a drug?
@Pól Pot: AZT and Oxycontin, my poor fellow with a good night’s rest, and you’ll be right as rain. Give your depressed wife handfuls of benzodiazepines and if she’s still feeling out of sorts, Pervitin.
@JB Software: it’s been proven to be a safe and effective treatment in multiple studies that’s why Australia legalised it last year. The big pharma will try to prevent it from being passed in the US as they stand to lose billions if it does pass
@Pól Pot: they don’t? Wow, I’m going to set up a drug company now and sell smarties as a cure for everything. Thanks for letting me know it was so easy.
@JB Software: What was Hoffman attempting to cure before his lovely bike ride on April 19th in 1943, infinite wisdom?
@Pól Pot: he was trying to come up with a treatment for migraines. But I’m sure you’ll have a different take to suit your narrative. And I’m not sure what that has got to do with your original rediculous comment earlier about drug companies not having to do any testing.
@JB Software: I hope your GP at least has a warm bedside manner as he blindly experiments with your body and mind.
@Pól Pot: good to know you don’t seek medical advice/treatment for any issues. Darwinism at its finest.
@JB Software: What, like Oxycontin?
@JB Software: Baaaa.
@Pól Pot: You are a turd with a killer name. Your 2 braincells are trying to escape.
@Pól Pot: quack quack
@JB Software:
The most recent drug trial found that more than 86 percent of those who received MDMA achieved a measurable reduction in severity of their symptoms. About 71 percent of participants improved enough that they no longer met the criteria for a PTSD diagnosis.
@Jonny Hellzapoppin: so just ignore all the other drugs/medication that have helped people?? You sound really sensible.
@JB Software: you mean like the way Covid vaccines were tested?
@JB Software: God you are so naive. I suggest you watch the series Dope Sick, or Faucis HIV treatment in the 80s or the adverse events or deaths reported to VAERS or the UKs Yellow Card system. Pharma regulation is so corrupt. It’s all about the Benjamin’s baby.
@Paul: they actually were tested but there’s no point reasoning with someone who gets medical advice from social media sites.
@JB Software: like vaccines?
No they don’t. Recent history proves you wrong regarding your comment.
@Ger Whelan: you’re not wrong to be sceptical, and for many drugs and diseases you’re right, but you might want to look at Cracked by James Davies and the use of studies around psychiatric drugs SSRIs like Prozac; the FDA makes no secret that companies need to submit a small number of studies showing a drug works, and there is no rule on releasing all the studies conducted. Results not good enough? Fine, finance another 20 trials, one of them is bound to be better
This the same FDA that says Oxycontin is a wonder drug?
@Alan Kennedy: The real problem – the real cause of the problems – in the US is its privatised health care.
The FDA’s role is to either approve, or otherwise, drugs.
Morphine is highly addictive.
But has its place in health care, as I am thankful for.
So do lots of drugs.
But the entirely profit driven model of US health care is easily abused by the unscrupulous.
And that is what the Sackler family did. They pushed, and pushed, and pushed Oxycotin onto doctors, making claims about its safety, pushing them to prescribe higher and higher doses, to sell more and more, and make obscene profits for themselves.
Oxycotin should have been used with the similar safeguards as Morphine.
And the US justice system has still not held that family to account for what they did. For the countless lives they destroyed.
And until the first such billionaire is properly held to account by the US justice system, then there is a green light for others to repeat what the Sacklers did.
@Alan Kennedy:
The most recent drug trial found that more than 86 percent of those who received MDMA achieved a measurable reduction in severity of their symptoms. About 71 percent of participants improved enough that they no longer met the criteria for a PTSD diagnosis.
More lost time for invaluable unprecedented therapeutic benefits. Get back to the machine, and don’t forget to keep horsing those SSRIs. You only think you’re not fulfilled.
@Pól Pot: Immeasurable appreciation and love for existence and your fellow humans is not proven to be risk-free.
@Pól Pot: It’s OK Pol.
The big-bad wolf isn’t going to make you take these drugs.
You can stick to your Kool-Aid.
@ItWasLikeThatWhenIGotHere: Yeah, I’m the one in Jonestown.
@Pól Pot: Guyana?
I was aware any of your cult survived.
@ItWasLikeThatWhenIGotHere: …wasn’t…
@ItWasLikeThatWhenIGotHere: Of you aren’t. You’re not particularly aware of anything.
@Pól Pot: are you aware you cannot string a sentence together?
@Ger Whelan: Sorry, it’s all the amanita muscaria I had for lunch. At least I don’t have to manage a dosette box. Enjoy yours, baaaaa.
@Pól Pot: lay off the drugs bud. They clearly aren’t doing you any favours.
@Pól Pot: why do you choose to name yourself after someone who murdered 2 million people, or half of the population of his country before Vietnam intervened?
@Alex: What are you talking about?! Pòl is an Irish name.
And they just ignore the Adderall use. Who needs MDMA when you have Crystal meth on tap
@Shimo F: if it’s good enough for Sleepy Joe, it’s good enough for us!
@Shimo F: Surely that’s only prescribed to help children with a specific disorder? It’s not a trend, it helps them focus on their studies where previously they were unable to do much.
@Shimo F: Adderall is hugely beneficial to those that need it, neither it OR mdma will cause one burn their house down for a life of looking for cooper wire in abandoned buildings, like Meth will ffs.
No mention of the “risks” at all. Hardly because they’re minimal, especially when compared with alcohol, tobacco & firearms? All of which are positively encouraged in the good ol’ U, S & A. MDMA wiill never be licensed in the US because it’s readily available and the white ruling class won’t be able to extract huge profits, it’s that simple.
@Jonny Hellzapoppin: I’m actually amazed that someone is stumping up for clinical trials in something they can’t patent.
Perhaps they’re hoping for an exclusive license like the Coca-Cola subsidiary that imports Coca leaves.
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