PCRI Contributes to the First FDA Approval of a Non-Antipsychotic Drug to Treat Agitation in Dementia

The first Non-Antipsychotic Drug to Treat Agitation in Dementia, by Axsome Therapeutics, has been approved by the FDA, and we are so proud to have been a part of contributing to this groundbreaking approval.

Premier Clinical Research Institute was one of the contributing research sites that provided valuable data to the clinical trials that eventually led to the FDA's approval of the medication, Auvelity for this condition.

Auvelity was already FDA-approved as an oral antidepressant for adults with major depressive disorder. The drug combines dextromethorphan and bupropion for rapid symptom relief. Now, after undergoing various phases of new clinical trials (like the one(s) performed by PCRI), it has been approved for another condition, symptoms of agitation in dementia patients.

Why is it so important?

Up to 76% of patients with Alzheimer’s disease/Dementia experience agitation, including pacing, restlessness and verbal or physical aggression. The existing options for treating these symptoms carries a heavy risk for this delicate population.

Having another tool available that we can offer these patients is such an exciting and important advancement for the millions of people, caregivers and families suffering from one of the most burdensome and difficult parts of this disease (ie: verbal and physical aggression).

Finding new and improved ways of treating the symptoms of this debilitating disease is certainly a step in the right direction. We hope to keep this momentum and continue contributing to medical science to one day maybe find a way to stop it in its tracks.

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Read more about this:

FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia | FDA

Do you or a loved one suffer from Dementia? Learn about our current clinical trials and find out if you'd be a good candidate, and if it could be beneficial to participate.

pcrinstitute.com/participate