Alkermes and J&J initiate Ph III trial of three-month Invega Sustenna

USA-based Alkermes (Nasdaq: ALKS) and partner health care giant Johnson & Johnson (NYSE: JNJ) have started a Phase III clinical trial with a three-month formulation of Invega Sustenna (paliperidone palmitate) for schizophrenia.

This will be the first-ever three-month atypical medication in development for schizophrenia. It expands the J&J/ALKS franchise of long-acting drugs for schizophrenia, currently with more than $2 billion in annual product sales, with approved products Invega Sustenna (1-month administration) and Risperdal Consta (risperidone; once every 2 week administration) – both long-acting injectable medications for atypical antipsychotic daily pills. Invega Sustenna generated sales of $499 million in the first quarter of 2012.

Two Phase III studies are expected to enroll around 1,800 patients with schizophrenia and will assess the efficacy, safety and tolerability of the three-month injectable formulation. These studies are expected to be completed in the second half of calendar 2014.