With Thursday approval from the U.S. Food and Drug Administration for Cobenfy, adults living with schizophrenia will have access to the first new treatment for the condition in decades.
Approximately 1% of Americans are affected by schizophrenia, per Johns Hopkins Medicine. This serious mental illness affects how people think, feel and behave, the National Institute of Mental Health explained.
“People with schizophrenia may seem like they have lost touch with reality, which can be distressing for them and for their family and friends,” said the institute. “The symptoms of schizophrenia can make it difficult to participate in usual, everyday activities, but effective treatments are available. Many people who receive treatment can engage in school or work, achieve independence, and enjoy personal relationships.”
Symptoms of schizophrenia can include: psychotic symptoms such as hallucinations, delusions and hearing voices; negative symptoms such as loss of interest or enjoyment in daily activities, withdrawal from social life and difficulty showing emotions; and cognitive symptoms that include problems in attention, concentration, and memory. Genetics, stressful environments, brain structure and brain function can all contribute to the development of schizophrenia.
“Millions of people around the world live with schizophrenia, but many do not receive the symptom management support they need,” said Schizophrenia & Psychosis Action Alliance CEO Gordon Lavigne in a video address about the FDA’s approval of Cobenfy. “People with schizophrenia have the right to effective medicines and they deserve respect and recognition that they are people who want to live and thrive.”
Antipsychotic medication and cognitive behavioral therapy are some of the main treatments for patients living with schizophrenia.
According to the FDA, Cobenfy (xanomeline and trospium chloride) from Bristol Myers Squibb is an antipsychotic medication that targets cholinergic receptors. This deviates from using antipsychotic medication targeting dopamine receptors, the longstanding standard of care for the condition.
Cholinergic receptors respond to acetylcholine, described by the Cleveland Clinic as a neurotransmitter that “excites” nerve cells and causes them to fire off messages. In addition to playing a major role in voluntary muscle movement, it also “plays an important role in brain nerve cells, in such processes as memory, thinking and learning,” said the clinic.
“Cobenfy’s effectiveness for the treatment of schizophrenia in adults was evaluated in two studies with identical designs,” said the FDA. “Study 1 and Study 2 were 5-week, randomized, double-blind, placebo-controlled, multi-center studies in adults with a diagnosis of schizophrenia according to DSM-5 criteria.”
To measure the efficacy of the treatment, researchers looked at the change from baseline in the Positive and Negative Syndrome Scale (PANSS) – a 30-item scale that measures the symptoms of schizophrenia – total score at week 5. Each item was rated on a seven-point scale by a clinician.
“In both studies, the participants who received Cobenfy experienced a meaningful reduction in symptoms from baseline to Week 5 as measured by the PANSS Total Score compared to the placebo group,” the FDA said.
Lavigne said new treatment options such as Cobenfy are important because patients with schizophrenia can often spend years trying to find a treatment program that works for them.
However, as with any medication, there are some risks and side effects associated with Cobenfy. According to the FDA, it can cause urinary retention, increased heart rate, decreased gastric movement or angioedema (swelling beneath the skin) of the face and lips. There is also a risk of liver damage, so it is not recommended for patients with mild hepatic impairment. Since it is substantially excreted by the kidneys, Cobenfy is not recommended in patients with moderate to severe renal impairment.
“The most common side effects of Cobenfy are nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia (increased heartbeat), dizziness and gastroesophageal reflux disease,” said the FDA.
People with schizophrenia are usually diagnosed sometime between age 16 and their early 30s after a first episode of psychosis. Seeking treatment soon after that first episode is an important part of managing the illness.
While most people with schizophrenia are not violent, they are at higher risk of being harmed by others than the general population. Globally, schizophrenia is one of the 15 leading causes of disability – individuals with the condition are at a greater risk of dying at a younger age and 5% die by suicide.
“It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” said Tiffany Farchione, director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
Lavigne said the FDA’s approval is a “monumental step” for the community of patients and caregivers dealing with schizophrenia.
“Imagine the relief of families seeing their loved ones return to the dinner table, share smiles, and rejoin the fabric of daily life,” he said.
Along with the FDA approval for Cobenfy, Bristol Myers Squibb also announced the launch of the COBENFY Cares program to support patients who have been prescribed the medication. Those patients will be able to enroll in the program in late October, corresponding with product availability.