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Dr. Portsteinsson:
This is CME on ReachMD and I'm Dr. Anton Porteinsson. Joining me today is Dr. Brendan Montano.
Brendon, I want to talk about some of the emerging therapeutics to treat the agitation in Alzheimer's disease. As you know, this is what I live for, that is drug development and discovering new treatments. And there certainly is a tremendous need for options in treating agitation and aggression in Alzheimer’s disease. We're lucky to have the first FDA-approved the treatment that is brexpiprazole, that was studied through three large clinical trials that showed that 2 and 3 milligrams daily were superior to placebo with an acceptable safety and tolerability profile. But what are some of the other drugs that are in late-stage development? Well, let me count the ways. We have medications that basically use dextromethorphan, the cough syrup, as a core, but then they have a metabolic inhibitor that allows the blood concentrations of dextromethorphan to rise. One of them is dextromethorphan with bupropion, and that's in late-stage clinical trials and has shown promise so far. That medication is also FDA approved for the treatment of depression.
Another dextromethorphan drug that had the quinidine inhibitor is approved at the market for the treatment of cerebral palsy, but then it appears that the development for agitation in Alzheimer's disease has been stopped.
We have a medication that is in development for acute agitation, so acute behavioral disruptions, and that is sublingual dexmedetomidine, that is also used for acute treatment of agitation in schizophrenia or bipolar disorder. So, we'll see what the role for that may be.
Furthermore, we have drugs that fall into the cannabinoid family, such as nabilone, or THC, and we are often seeing people actually use those medications either through medical pot dispensaries or through recreational ways, and there may well be benefits, but there are also potential concerns about that. So, I look forward to seeing the full data as to what that might bring us.
Furthermore, there are other drugs that kind of fall into the atypical antipsychotic class of drugs. Some of the very new ones that are being studied for this. So, there is a broad development and effort going on in the field of agitation. And I hope that within the next few years, we will have more medications that are FDA approved for this indication than solely brexpiprazole.
But what has been your insight into this aspect of drug development and agitation?
Dr. Montano:
Yes, and I appreciate you're putting those out there because you're right on. I checked when this subject was coming up and I wanted to know how many clinical trials were there ongoing? It appears there are seven Phase 3 trials. Seven. And along with that, eight Phase 2 trials as of January 2024. So, there's a huge amount of activity that's going on with development of medications that are going to help this very distressing and troublesome diagnosis of agitation in the Alzheimer's patients. And the ones you mentioned, I think, are very good.
Dr. Porteinsson:
Thank you, Brendon. And with that, our time is up. We hope you found our perspectives useful and thank you for listening.
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