BioCentury
ARTICLE | Clinical News

Braeburn’s BB0817 risperidone implant meets Phase II/III PK endpoint

May 12, 2017 5:38 AM UTC

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) reported data from a Phase II/III trial in more than 50 stabilized schizophrenic patients showing that BB0817 met the primary endpoint of achieving comparable plasma levels of 9-hydroxy-risperidone -- the active metabolite of risperidone -- over 6 months to that of oral risperidone. BB0817 consists of a subcutaneous implant for 6-month delivery of risperidone using MedLaunch technology.

The open-label, U.S. trial enrolled patients with schizophrenia or schizoaffective disorder who were stable on once-daily 4 mg oral risperidone for ≥8 weeks to receive three 300 mg subcutaneous BB0817 implants in the upper arm...