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FDA Approves Dual-Chamber Syringe for Abilify Maintena (aripiprazole) for Schizophrenia

Princeton, N.J. and Deerfield, Ill. – September 29, 2014 – Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck announced today that the U.S. 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. 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.

“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.

About Abilify Maintena (aripiprazole)

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.2 Depot formulations of antipsychotic agents provide patients with concentrations of active drug that remain at a therapeutic range for an extended period of time.1,2 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.

About Otsuka Pharmaceutical Development & Commercialization, Inc.

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.

OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.

About Lundbeck in the U.S.

Lundbeck in the U.S., headquartered in Deerfield, Illinois, is a wholly-owned subsidiary of H. Lundbeck A/S in Denmark. Globally, our mission is to help people suffering from psychiatric and neurologic disorders. To drive this mission in the U.S., nearly 800 employees are engaged in the research, development, production, marketing and sale of innovative specialty therapies that fulfill unmet medical needs. We see the person behind the disease and how it affects the lives of patients, families and caregivers. Lundbeck is actively involved with hundreds of local and national U.S. events each year that support our patient communities.

References

  1. Kane, JM et al. “Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia: A 52-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study.” J Clin Psychiatry 2012;73(5):617-624.
  2. Prescribing Information. ABILIFY MAINTENA™ (aripiprazole) for extended-release injectable suspension, for intramuscular use. February 2013.
  3. U.S. Food and Drug Administration (FDA). FDA Approved Drug Products: All approvals February 2013. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.MonthlyApprovalsAll.

Source: Otsuka America Pharmaceuticals, Inc.

Posted: September 2014

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Abilify Maintena (aripiprazole) FDA Approval History

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