US regulators have issued a green light for Lundbeck and Otsuka's Abilify Maintena injection for the treatment of schizophrenia, an intra-muscular, once-monthly, long-acting version of the oral blockbuster Abilify.
Abilify Maintena is the first dopamine D2 partial agonist given regulatory clearance as a once-monthly injection, and "contributes a new treatment option to address the ongoing need for relapse prevention in patients with schizophrenia, a chronic, debilitating disease", according to the firms.
Approval was based on data from a 52-week Phase III maintenance trial of the drug in patients with schizophrenia, which showed that it significantly delayed time to relapse compared to placebo, and lowered the percentage of subjects experiencing relapse, the groups note.
Abilify Maintena will be the first product to hit the market from a long-term global alliance between Otsuka and Lundbeck to develop CNS medicines, which the firms signed in 2011. The launch of the drug also represents Lundbeck’s first step into the US psychiatry market.
The companies said they expect that the product will start becoming available in the US on March 18, after which it will compete for market share with Johnson & Johnson/Alkermes' Risperdal Consta, a twice-monthly injectable version of the oral drug Risperdal (risperidone), and Invega Sustena, a once-monthly injectable version of Invega (paliperidone).
Alkermes also has a wholly-owned long-acting drug candidate, aripiprazole lauroxil (previously referred to as ALKS 9070), currently in a pivotal Phase III study in schizophrenia, with results expected at the end of 2013.
According to Alkermes, there is clinical evidence that long-acting antipsychotics have significant clinical impact for patient outcomes, helping to reduce hospitalisations, achieve better remission rates, and improve patient scores in disease severity.
In addition, it says that long-acting antipsychotics have grown in around one year from less than 7% to nearly 10% of the $20-billion-plus worldwide market for this class of drugs, "and yet long-acting medications are still under-utilised in many markets", highlighting their potential.