Otsuka America Pharmaceutical, Inc. (OAPI) and Lundbeck today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for a proposed new injection site—the deltoid muscle of the arm—for Abilify Maintena® (aripiprazole) for extended-release injectable suspension. If approved, healthcare providers will have both a gluteal and deltoid option for administering Abilify Maintena to patients with schizophrenia. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of July 30, 2015 to complete its review.
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced the presentation of Phase III study results evaluating the effects of an investigational compound, brexpiprazole, as monotherapy in adult patients with schizophrenia at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Phoenix, Arizona. The data were shared in two poster presentations, “A Multicenter, Randomized, Controlled, Phase III Trial of Fixed-dose Brexpiprazole for the Treatment of Adults with Acute Schizophrenia” and “Brexpiprazole for the Treatment of Acute Schizophrenia: A Randomized, Controlled Trial.”
– Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced the presentation of Phase III study results evaluating the efficacy of investigational compound brexpiprazole as adjunctive treatment to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) at the 53rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Phoenix, Arizona. The data were shared in a poster presentation, “Efficacy and Safety of Adjunctive Brexpiprazole (OPC-34712) in Major Depressive Disorder: Results of Two Pivotal Clinical Studies.”
– A late-breaking poster presentation focused on five-year vision data from Lundbeck’s SABRIL (vigabatrin) patient registry was presented at the annual meeting of the American Epilepsy Society (AES). The data set includes 6,823 patients enrolled from August 21, 2009 through August 26, 2014.1 The U.S. Food and Drug Administration (FDA) requires a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of SABRIL-induced permanent vision loss, including an ongoing patient registry.
– People living with epilepsy report increased self-esteem after participating in Studio E: The Epilepsy Art Therapy Program, according to a new study presented today at the annual meeting of the American Epilepsy Society (AES), in Seattle, Wash. Studio E is a multi-week program made possible nationwide through a partnership between the Epilepsy Foundation and the pharmaceutical company Lundbeck.