Aristada™ (aripiprazole lauroxil) – New Drug Approval • On October 5, 2015, Alkermes’ announced the FDA approval of Aristada (aripiprazole lauroxil) extended-release injection, an atypical antipsychotic, for the treatment of schizophrenia.

• Schizophrenia is a chronic, severe and disabling brain disorder affecting an estimated 2.4 million Americans. Typically, symptoms include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.

• Aristada’s approval was based on data from a double-blind, placebo-controlled 12-week trial involving 622 patients with schizophrenia. In addition, the efficacy of Aristada was established, in part, on the basis of efficacy data from trials with oral aripiprazole.

— Aristada significantly improved symptoms of schizophrenia compared to placebo at day 85.

• Similar to other atypical antipsychotics, Aristada carries a boxed warning for increased mortality in elderly patients with dementia-related psychosis.

• Other warnings and precautions for Aristada include cerebrovascular adverse reactions, including stroke; neuroleptic malignant syndrome; tardive dyskinesia; metabolic changes; orthostatic hypotension; leukopenia, neutropenia, and agranulocytosis; seizures; potential for cognitive and motor impairment; body temperature regulation; and dysphagia.

• The most common adverse reaction (≥ 5% and at least twice that for placebo) with Aristada use was akathisia.

• Aristada is administered by intramuscular injection in the deltoid (441 mg dose only) or gluteal (441 mg, 662 mg, or 882 mg) muscle by a healthcare professional.

— Aristada can be initiated at a monthly dose (441 mg, 662 mg or 882 mg) or every 6 week dose (882 mg). — For patients naïve to aripiprazole, tolerability should be established with oral aripiprazole prior to initiating treatment with Aristada. — In conjunction with the first Aristada injection, treatment should be administered with oral aripiprazole for 21 consecutive days.

• Alkermes plans to launch Aristada immediately. Aristada will be available as an extended-release injectable suspension in 441 mg, 662 mg, and 882 mg single-use pre-filled syringes.

• Aripiprazole is also available in various formulations: extended-release injection (Abilify Maintena™), tablets, and oral solution.

— Aripiprazole tablets and oral solution are generically available.

• Other branded long-acting injectables for the treatment of schizophrenia include Zyprexa® Relprevv™ ® (olanzapine), Invega® Sustenna® (paliperidone), Invega Trinza™ (paliperidone), and Risperdal Consta® (risperidone).

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