This newsletter includes the most recent news on the approval process of pimavanserin for Alzheimer’s disease psychosis. We also share practical tips for managing delirium, key points from a presentation on the management of explosive behavior in children and adolescents, and our practical research summaries (Quick Takes).
News on Pimavanserin for Alzheimer’s Disease Psychosis
Currently, no treatments are approved for hallucinations and delusions associated with Alzheimer’s disease psychosis.
- What is pimavanserin?
- It’s a drug that acts as a selective serotonin inverse agonist and antagonist that preferentially targets 5-HT2A receptors.
- What is pimavanserin FDA approved for?
- In 2016, it was approved for treating psychotic symptoms associated with Parkinson’s disease, its main advantages being the lack of dopaminergic activity and not impairing motor function.
- In April 2021, the FDA denied approval for psychosis related to all-cause dementia due to an absence of statistically significant changes in some dementia subgroups.
- In February 2022, the manufacturer submitted a Supplemental New Drug Application (sNDA) but this time for Alzheimer’s disease psychosis.
- What is the evidence for Alzheimer’s disease psychosis?
- Between 2014 and 2016, the manufacturer sponsored a phase 2 study where they found a positive effect at 6 weeks.
- However, at 2, 4, 9, and 12 weeks, there was no statistically significant difference. Dr. Phelps discussed these findings in a Quick Take; you can learn more here.
- Subsequent analyses have shown a more significant benefit in participants with more severe psychosis, and a post hoc analysis showed an improvement in agitation and aggression.
- What is the most recent news on the FDA approval process for Alzheimer’s disease psychosis?
- On June 18, 2022, the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) voted that the evidence presented does not support the efficacy of pimavanserin for treating hallucinations and delusions in patients with Alzheimer’s disease.
- Does this mean it was not approved by the FDA?
- No. The end of the review period for this therapy’s sNDA is August 4, 2022. However, the FDA usually considers the PDAC opinion in making their decision.
Management of Delirium, With Scott R. Beach, M.D., FACLP
In this interview, Dr. Scott Beach reviews essential principles in the assessment and management of delirium. He presents therapeutic options for the management of delirium as well as preventive strategies for patients at risk for its development. Related phenomena, such as postdelirium PTSD and COVID-19 delirium, are likewise discussed.
Interview highlights include the following:
- The management of delirium differs depending on a patient’s risk profile and delirium type.
- Antipsychotics are primarily used for the management of psychotic symptoms and agitation related to delirium. These medications do not shorten or reverse the course of delirium.
Learn more and earn 0.75 CME credits here.
Managing Explosive Behavior in Children and Adolescents
In this video lecture, Dr. Vaudreuil discusses the management of explosive behavior in children and adolescents, including common differential diagnoses and frequent comorbid conditions. She provides treatment guidelines for acute and chronic aggression and reviews the use of different medication classes and psychosocial interventions.
Differential Diagnosis of Explosive Behavior: Mood and Anxiety Disorders and Disruptive Behavior Disorders
- In children with mood disorders, explosive behavior is often accompanied by changes in mood, sleep, appetite, energy, and functioning.
- In children with disruptive behavior disorders, explosive behavior often occurs in response to limit setting.
Learn more and earn 0.75 CME credits here.
Quick Takes: Informing Your Practice
Rapid Tranquilization of the Agitated Patient in the Emergency Department
- Comparing 11 medications (monotherapy and combinations) for the treatment of severe agitation in the emergency department, a new network meta-analysis finds droperidol and ketamine superior to haloperidol and other alternatives—but not by much.
- Emergency physician organizations have concluded that droperidol is effective for agitation, and that its risk of QT prolongation (which became a prominent concern after a 2001 FDA warning) has been overemphasized. Learn more.
A Mini-Review of Pharmacologic and Psychosocial Interventions for Reducing Irritability Among Youth With ADHD
- Even when ADHD is concurrent with disruptive mood dysregulation disorder, irritability responds to routine ADHD treatments.
- Parent/family behavioral training and rigorous optimization of methylphenidate led to remission of symptoms in 63% of participants in a clinical trial for young people who already had stimulant treatment. Learn more.
Listen to or read the full volume, and earn 0.5 CME credits here.
Listen to Our Podcast: Psychopharm Updates
Don’t miss out on the latest updates in psychopharmacology! Each episode of our podcast showcases one of our products on a regular basis: Video lectures, Quick Takes, and Expert Consultations. We update our feed every 5 days.
References
Ballard, C., Banister, C., Khan, Z., Cummings, J., Demos, G., Coate, B., Youakim, J. M., Owen, R., Stankovic, S., Tomkinson, E. B., McDermid, J., Ocal, D., Testad, I., Qayyum, M. A., Kemos’, P., Borejko, O., Megalogeni, M., Brookes, E. V., Petrava, A., … Nunez, K. (2018). Evaluation of the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer’s disease psychosis: A phase 2, randomised, placebo-controlled, double-blind study. The Lancet Neurology, 17(3), 213-222.
U.S. FOOD AND DRUG ADMINISTRATION FDA. (2022, June 16). Meeting of the psychopharmacologic drugs advisory committee. FDA. https://www.fda.gov/advisory-committees/advisory-committee-calendar/june-17-2022-meeting-psychopharmacologic-drugs-advisory-committee-meeting-announcement-06172022#event-information
