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Weekly Oral Risperidone Pill Maintains Steady Levels in Phase 3 Schizophrenia Trial

Researchers plan larger trials before seeking FDA approval for the adaptable weekly capsule following its phase 3 success

The ingestible capsule is about the size of a multivitamin, and once swallowed, it expands into a star shape that helps it remain in the stomach until all of the drug is released.

Overview

  • The ingestible capsule expands into a six-armed star in the stomach and remains for about a week before its arms break off and pass through the digestive tract
  • In an open-label study of 83 patients at five U.S. sites, weekly dosing upheld risperidone concentrations within the therapeutic range over five consecutive weeks
  • Symptom assessments using the Positive and Negative Syndrome Scale showed stable schizophrenia control throughout the trial period
  • Reported side effects were mild and transient, primarily early acid reflux and constipation among a minority of participants
  • Developed over a decade at MIT and advanced by Lyndra Therapeutics, the weekly-dose platform is being adapted for other medications as researchers prepare larger trials and an FDA application