H. Lundbeck and Otsuka Pharmaceutical Co., Ltd. have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for Abilify Maintena (aripiprazole), an intramuscular (IM) depot formulation for the maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

The pharmacological properties of aripiprazole are mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism at serotonin 5-HT2A receptors. Abilify Maintena is a once-monthly injectable form of aripiprazole that has already received regulatory approval in the US. It represents an alternative treatment option to address the need to reduce the risk of relapse (relative to placebo) in patients with schizophrenia.

The benefits with Abilify Maintena are its ability to reduce the proportion of stabilised patients experiencing relapse in long term use and its properties to act as long acting agent, allowing a monthly administration instead of a daily oral intake of aripiprazole. Patients are previously stabilised with oral aripiprazole.

"Abilify Maintena has been available in the US for some six months with encouraging feedback from patients and physicians, and we now look forward to launching this important treatment alternative together with our partner into the psychiatric community in Europe as well," said Ole Chrintz, senior vice president, International Markets & Europe at Lundbeck. "Abilify Maintena represents an important treatment option for patients, their physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia.”

"I am delighted that we now have a positive opinion for Abilify Maintena from the CHMP and if approved will be able to provide European patients with a long-term maintenance option for schizophrenia," said Ole Vahlgren, CEO & president, Otsuka Europe.

The efficacy of Abilify Maintena was demonstrated in two double-blind, randomised phase III trials over 38 and 52 weeks respectively. In the primary pivotal trial analysis of the primary efficacy endpoint, the proportion of patients experiencing impending relapse by the end of week 26, demonstrated non-inferiority of Abilify Maintena to oral aripiprazole and superiority to a sub-therapeutic dose of aripiprazole once monthly. The key secondary endpoint, time to relapse, supported the efficacy in maintenance treatment.

In the second efficacy trial, Abilify Maintena significantly delayed time to relapse compared to placebo (primary efficacy endpoint). In a key secondary endpoint, the percentage of subjects experiencing relapse was also significantly lower with Abilify Maintena compared to placebo at the end of the study.

The safety profile for Abilify Maintena was comparable to oral Abilify.The most common side effects are weight gain, akathisia (restlessness), insomnia (difficulty in sleeping), injection site pain.

On 11 November 2011, Otsuka and Lundbeck announced the formation of an alliance to collaborate on the development and commercialisation of up to five early and late stage compounds in development. Abilify Maintena is expected to be the first approved and commercialised product in the EU from the global alliance between the two companies, focused on developing Central Nervous System (CNS) therapies worldwide.

Lundbeck will make a milestone payment to Otsuka of US$ 75 million upon the European Commission's final approval of Abilify Maintena.

Abilify Maintena powder and solvent for prolonged-release suspension for injection, an IM depot formulation of aripiprazole, is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

After an initial injection of Abilify Maintena along with a transitional 14-day dosing of oral aripiprazole treatment, subsequent injections of Abilify Maintena provide uninterrupted medication coverage for 30 days at a time.

H. Lundbeck is a global pharmaceutical company specialized in brain diseases and have been at the forefront of research within neuroscience.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.