Lancet study illustrates drug delivery “milestone”

Credit: Melanie Gonick/MIT

Researchers have developed a once-weekly oral capsule with an innovative delayed drug release mechanism. This development could help certain patients, such as those with schizophrenia, to take their medicines more consistently.

As the drug device can be delivered orally, the new pill “represents an important option that can assist with adherence for the many patients who would prefer oral medications versus injectable formulations,” explained Leslie Citrome, a Clinical Professor of psychiatry and behavioural sciences at New York Medical College School of Medicine, US, and lead author.

“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,” commented Giovanni Traverso, an Associate Professor of mechanical engineering at MIT, a gastroenterologist at Brigham and Women’s Hospital, an associate member of the Broad Institute, and an author of the study.

The six-armed, star-shaped drug delivery device can be folded inward and encased in a smooth capsule the size of a multivitamin. Once ingested, the device reaches the stomach it expands into a star shape. Its full drug payload is slowly delivered over weeks or months, the researchers explained. The arm segments of the device break off after about one week, enabling it can move through the digestive tract, they shared.

Addressing medicine adherence challenges in schizophrenia

Results from the Phase III clinical trial, published in The Lancet Psychiatry, found that the treatment regimen maintained consistent drug levels in schizophrenia patients and controlled their symptoms in a comparable way to a daily dose. Less variation in drug levels were observed in the body compared to a pill taken daily.

Of the 83 patients enrolled in the study, forty-five completed the study. They took one capsule of risperidone once weekly. The findings demonstrated a sharp increase of the level of the medicine in the patient’s blood on the day of administration. These levels slowly decline over the following week; all levels were in optimal range.

This new data from the study represent a major milestone in this approach to drug delivery, according Traverso. It shows “that what we had hypothesised a decade ago, which is that a single capsule providing a drug depot within the GI tract could be possible. Here what you see is that the capsule can achieve the drug levels that were predicted and also control symptoms in a sizeable cohort of patients with schizophrenia.”

The investigators anticipate conducting bigger Phase III studies of this novel delivery approach for risperidone. They are also preparing to evaluate this capsule in Phase I trials to deliver other drugs, including contraceptives.

The study was funded by MIT spinout Lyndra Therapeutics.