From S&PAA
People living with schizophrenia and other psychosis spectrum disorders are too often misunderstood or ignored, and current treatments are outdated and can cause significant side effects. On November 2, 2022, the schizophrenia community finally had the spotlight, as those living with the condition and their family members shared their treatment needs and concerns with drug developers and FDA staff.
The Externally-Led Patient-Focused Drug Development (PFDD) meeting – “Reimagine Schizophrenia: Transforming How We Are Treated, Function and Thrive” – offered the chance to make what matters to those living with the neurobiological brain disease a higher priority in drug development and the FDA review process.
The meeting was co-hosted by the Schizophrenia & Psychosis Action Alliance, the American Foundation for Suicide Prevention, Mental Health America, the National Alliance on Mental Illness, and the National Council for Mental Wellbeing.
The U.S. Food and Drug Administration created the PFDD program in 2012 to collect information about the patient perspective on drug development – specifically, what people living with a disease considered to be meaningful treatment benefits and how they want to be involved in the drug-development process.
While current treatments for schizophrenia can help control symptoms, most have significant side effects, such as weight gain and tardive dyskinesia, a condition that causes involuntary facial and other muscle spasms. Fortunately, many new treatments are in development, making it more critical than ever that we tell drug developers and regulators what we need from new treatments: what benefits we expect and what risks we may be willing to tolerate if we can achieve those benefits.
Comments from David E. Geiger, MEE, PE (RET.)
This past November 2, 2022, there was an exciting event. S&PAA was able to schedule a 5-hour conference with the FDA regarding drug development and testing for those who have schizophrenia. I am one of those, and I was one of the panelists.
It was a virtual conference with several hundred people, and we heard from those who have the disease as well as those who are caretakers of someone who has it. We heard from the top ranks of the FDA about how important this conference is.
S&PAA is now working on the “Voice of the Patient”, a report of what was found in the conference regarding patients with schizophrenia. That will not be available until sometime in early 2023. In the meantime, I sold a few books there.
Reach the conference recording at their website.
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