Health Canada has issued a notice of compliance for Otsuka and Lundbeck’s Abilify Maintena, an intramuscular (IM) once-monthly injectable formulation, for the maintenance treatment of schizophrenia in stabilised adult patients.
The drug will be the first commercialised product in Canada from the global Otsuka-Lundbeck alliance, which is focused on developing central nervous system (CNS) therapies worldwide.
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Both firms expect that the once-monthly injectable formulation will be available in Canada in April.
The product is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorisation for maintenance treatment in schizophrenia.
The drug helps in reducing the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia.
According to the controlled clinical trials, the drug is seen to be significantly superior compared with non-active treatments (placebo or pseudo-placebo) in the prevention of psychotic symptoms/impending relapse for up to 38 weeks after stabilisation with oral aripiprazole.
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By GlobalDataIn addition, efficacy was found to be comparable with that of oral aripiprazole with a similar tolerability profile.
Efficacy was showed through two pivotal trials including a 38-week, active-controlled trial to evaluate the proportion of subjects meeting impending relapse criteria and a 52-week, placebo-controlled trial, which examined the time to impending relapse.
In the second trial, time to impending relapse was significantly delayed with Abilify Maintena compared with IM placebo.
The global alliance between Otsuka and Lundbeck was established in November 2011 to bring their experience and resources in the CNS area to introduce next-generation treatments for conditions such as schizophrenia, depression, Alzheimer’s disease (AD) and alcohol dependency.
