The single-dose, open-label study is designed to assess the pharmacokinetics, safety and tolerability of a gluteal injection of this risperidone formulation in approximately 26 patients diagnosed with chronic, stable schizophrenia. A two-week long-acting injectable formulation of risperidone, marketed as Risperdal Consta, is commercially available in more than 60 countries.
Risperdal Consta is manufactured by Alkermes and marketed in the US by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals. Administered once every two weeks, Risperdal Consta is said to be the first and only long-acting atypical antipsychotic commercially available in the US.
Elliot Ehrich, chief medical officer of Alkermes, said: “We are pleased to build upon our formulation expertise with Risperdal Consta, an important therapy with demonstrated ability to improve outcomes for many patients with schizophrenia. A four-week long-acting injectable formulation of risperidone would provide another valuable approach for managing this serious, chronic disease.”