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news.Otsuka Pharmaceutical Development & Commercialization and Lundbeck has announced that the US Food and Drug Administration (FDA) has approved a new formulation of Abilify Maintena (aripiprazole) for extended-release injectable suspension – a pre-filled dual-chamber syringe.
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Abilify Maintena is an atypical antipsychotic indicated for the treatment of schizophrenia; efficacy was demonstrated in a placebo-controlled, randomized-withdrawal maintenance trial in patients with schizophrenia and additional support for efficacy was derived from oral aripiprazole trials.
The companies expect the dual-chamber syringe will be available in the U.S. in January 2015.
Highlights
- Dual-chamber syringe offers healthcare providers more flexibility during patient office visits
- First of several anticipated product enhancements to Abilify Maintena
"Since March 2013, Abilify Maintena has been an important treatment option for people living with schizophrenia. Otsuka and Lundbeck continue to be committed to ongoing innovation to address the challenges associated with treating this population," said Robert McQuade, Ph.D., Executive Vice President and Chief Strategic Officer of Otsuka.
"With the approval of the dual-chamber syringe, we are pleased to introduce the first of several anticipated product enhancements that can simplify the delivery of care for patients receiving Abilify Maintena, as compared to the current formulation; and it offers healthcare providers a new, easier to use option during their office visits with patients."
The Abilify Maintena dual-chamber syringe will be available in 300 mg and 400 mg doses for deep intramuscular gluteal injection only by healthcare professionals.
Abilify Maintena (aripiprazole) for extended-release injectable suspension is indicated for the treatment of schizophrenia. Efficacy was demonstrated in a placebo-controlled, randomized-withdrawal maintenance trial in patients with schizophrenia. It is the first and only once-monthly injection of a dopamine D2 partial agonist and was approved by the U.S. Food and Drug Administration (FDA) on February 28, 2013.2,3
Abilify Maintena, an atypical antipsychotic, is an intramuscular depot formulation of aripiprazole. It is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly.
After an initial injection of Abilify Maintena along with an overlapping 14-day dosing of oral antipsychotic treatment, subsequent injections of Abilify Maintena provide uninterrupted medication coverage for 30 days at a time.
It provides a treatment option to address one of the most important considerations in the management of schizophrenia – reducing the risk of relapse, or the re-emergence or worsening of symptoms. Depot formulations of antipsychotic agents provide patients with concentrations of active drug that remain at a therapeutic range for an extended period of time.
Abilify Maintena became available for prescribing in the U.S. on March 18, 2013. Abilify Maintena is not approved for the treatment of patients with dementia-related psychosis.