FDA advisors oppose MDMA treatment for PTSD

Pharmaceutical companies focused on psychedelics are under pressure after a Food and Drug Administration (FDA) panel voted against adopting MDMA treatment for PTSD. The FDA’s Psychopharmacologic Drugs Advisory Committee, which evaluated a proposed treatment by Lykos Therapeutics, felt there was insufficient evidence to support the drug's efficacy, though the FDA still has until August to take action.

Anjalee Khemlani joins Market Domination to break down where the panel of experts took issue with the trial data and future MDMA treatments that may break through.

For more expert insight and the latest market action, click here to watch this full episode of Market Domination.

This article was written by Gabriel Roy

Video transcript

Companies in the pharmaceutical sector specifically focused on psychedelics, are under pressure.

That's after a key vote from the Food and Drug Administration.

Angeli Kamlani is here with the details, and both of you and I are fascinated by this story.

There was an exploration and so there was an exploration of MD MA to treat post traumatic stress disorder.

So there was some question about whether the FDA panel was going to recommend that to prove it.

And they did not.

Right?

And that's just the panel.

We have to remember that the FDA still has until August 11th to take action on this.

So what happened was one company like O got their chance in front of this panel to explain and describe this clinical trial.

Now, the problem that the panel had is that, uh, what was effectively un blinding.

So we know that the gold standard for clinical trials is to make sure there's a placebo group and a, uh, group that receives the treatment.

Now in taking MD MA, also known as Ecstasy or Molly, you can't you really stop you.

You're right.

You can't know that you're not on it.

And so that's sort of where the conversation took place, and that's where it went.

There's also questions about whether or not you can prevent it from being abused, which is also come up.

It's important to point out in conversations about marijuana and those medical marijuana cases trials, and that has been a point of contention as well.

There important to remember, FDA has not approved any medical marijuana for use.

They just used stuff that's related to other parts of the cannabis plant, and that's why it hasn't come up as strongly in conversation as we saw with this.

Now there are other companies out there mind me being one of them that analysts are focused on, that has a better mid stage clinical trial coming up that could surpass what, like had So there is still a little bit of hope, essentially.

But right now what you're seeing is just pressure on the industry, pressure on the sector in particular, to really think about how they can actually bring this to market and really prove the medical use case.

And it seems like if one we're trying to draw parallels to the cannabis movement and how it became legalised, it was illegal for decades and decades.

And then suddenly there's a groundswell movement.

It gets approved by the states.

This is different.

It looks like quite different.

This is different.

There's no talk of recreational legalisation at all, in fact, because there is also talk about how there will be access to it, and it already is.

Access to it has been for decades, um, off market in the, uh illegally, and so that could continue and then push the illegal use of it further as a result.

So there's been a lot of focus on some of the same sort of topics, but different angle because it's a different drug altogether, with different, uh, sort of impacts to the person's body.

So that's sort of where the conversation goes interesting.

All right.

Thank you, O.

Of course,