May 17, 2022 – People living with schizophrenia and other psychosis spectrum disorders are too often misunderstood or ignored – by the public, by the healthcare system – and current treatments are outdated and often cause significant side effects. On Nov. 2, the schizophrenia community will finally have the spotlight, as those living with the condition and their family members share their treatment needs and concerns with drug developers and FDA staff who review new drug applications.
The Externally-Led Patient Focused Drug Development (PFDD) meeting – “Reimagine Schizophrenia: Transforming How We Are Treated, Function and Thrive” – offers 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.
“Schizophrenia is a treatable brain disease that deserves the same urgency and attention as any other chronic, organ-based illness,” said Gordon Lavigne, CEO of the Schizophrenia & Psychosis Action Alliance. “Our care system has failed people with this condition for too long. This is a ground-breaking opportunity to advocate for new, better treatments that give people with schizophrenia a chance to recover.”
The meeting will be 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 with regard to drug development – what people living with a disease consider to be meaningful treatment benefits and how they want to be involved in the drug-development process.
Many new treatments for schizophrenia are in development, making it more critical than ever for drug developers and reviewers to understand what treatment benefits people with schizophrenia expect – and what risks they may be willing to tolerate to achieve those benefits. Millions of people around the world live with schizophrenia, but many do not receive the treatment and support they need. This gap is caused by the complexities of the condition itself, but also by social stigma, health system limitations, discrimination, and poor reimbursement for treatment. The resulting cost to society in the United States is estimated at $281.6 billion each year.