A special type of slow-release drug delivery technology, developed by Lyndra Therapeutics, allows schizophrenia or schizoaffective disorder patients to take one pill of risperidone once a week rather than daily.
The pill, which expands into a larger star shape after being swallowed and slowly dissolves in the stomach over a week, performed well in an open label, non-randomized Phase III trial in patients with schizophrenia.
Up to five million people in the U.S. are thought to have schizophrenia or schizoaffective disorder, both of which can be very debilitating. Taking daily medication is challenging for these patients and non-adherence is thought to be as high as 50%.
Anti-psychotics such as risperidone are one of the most common treatments for schizophrenia or schizoaffective disorder. While long-acting versions of risperidone are available, to date they are all injectable, which can also make compliance difficult.
In this study, lead investigator Leslie Citrome, MD, a professor at New York Medical College, and colleagues developed a new oral long-acting delivery method to try and help schizophrenia or schizoaffective disorder patients with adherence in a non-invasive way.
“A primary treatment challenge for schizophrenia and schizoaffective disorder is medication adherence, which is made more challenging by a high pill burden and complex dosing schedules,” said Citrome in a press statement. “Identifying effective treatments, like a weekly oral administration can reduce poor health outcomes like relapses, suicides, and re-admission to hospitals amongst this patient population.”
As reported in Lancet Psychiatry, 47 patients completed the five week study and levels of the drug were maintained over the course of a week with similar levels of drug activity to daily, immediate release risperidone.
Adverse events were predominantly gastrointestinal and most were mild-moderate, although one serious case of esophagitis linked to the treatment was reported.
Co-author Giovanni Traverso, MD, PhD, an associate professor of mechanical engineering at MIT, and a gastroenterologist at Brigham and Women’s Hospital, has developed the slow-release technology with his lab for more than 10 years and is a co-founder of Lyndra Therapeutics.
“We’ve converted something that has to be taken once a day to once a week, orally, using a technology that can be adapted for a variety of medications,” he said. “The ability to provide a sustained level of drug for a prolonged period, in an easy-to-administer system, makes it easier to ensure patients are receiving their medication.”
The research team now plan to do further Phase III studies before they submit this technology for approval by the FDA.
While neuropsychiatric disorders are a current focus for Lyndra, the company also plans to apply the technology to other conditions that require regular medication.