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news.Otsuka and Lundbeck has received approval from Health Canada to use its intramuscular (IM) once-monthly injectable formulation 'Abilify Maintena' for the maintenance treatment of schizophrenia in stabilized adult patients.
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Abilify Maintena will be the first commercialized product in Canada from the global Otsuka- Lundbeck alliance, which is focused on developing Central Nervous System (CNS) therapies worldwide.
The two firms expect that the once-monthly injectable formulation will be available in Canada in April 2014.
The drug is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorization for maintenance treatment in schizophrenia.
It helps in reducing the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia.
The controlled clinical trials show that the drug is significantly superior compared to non-active treatments (placebo or pseudo-placebo) in the prevention of psychotic symptoms/impending relapse for up to 38 weeks after stabilization with oral aripiprazole.
Additionally, efficacy of the drug was calculated in two pivotal trials and is found to be comparable to that of oral aripiprazole with a similar tolerability profile.