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Johnson & Johnson group Janssen has filed an application in the U.S. to market a three-month injectable formulation of paliperidone palmitate for the treatment of schizophrenia – the first and only long-acting atypical antipsychotic that is administered four times a year. The move is considered a huge step toward treating individuals with the mental illness.
The filing follows a Phase III relapse prevention study of the drug involving more than 500 patients. The safety of the antipsychotic was proven to be consistent with its once-monthly predecessor Invega Sustenna, which was approved by the U.S. Food and Drug Administration in 2009.
"This innovative three-month formulation has the potential to positively affect the
care of many people with schizophrenia," Husseini Manji, head of neuroscience at Janssen R&D, said. "The option for this dosing schedule would offer a welcome new choice for patients and may provide benefits to society."
It’s hoped that the new three-month version of the drug will further boost treatment adherence rates. As the company noted, many patients with acute illness often don’t have insight into their disease, which contributes to their not taking medication or participating in treatment services. This could lead to potential relapse.
"Schizophrenia is often a devastating condition, and treatment interventions are needed early in the course of the disease," Dr. Joseph A. Kwentus, a psychiatrist at Hinds
Behavioral Health Services, said. "It's important that medical professionals, policy makers, and patients' loved ones support comprehensive treatment."
Schizophrenia is a complex and chronic brain disorder that effects about one percent of the population. If left untreated, the disorder can interfere with education, employment and interpersonal functioning. While there is currently no cure for the illness, those with the disorder can lead a meaningful life with a treatment regimen that might include medication, psychotherapy and other interventions. Daily pills and long-acting therapy are the main areas of treatment.
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