Dublin-based pharmaceutical Alkermes announced last Monday that the U.S. Food and Drug Administration (FDA) has approved Aristada, its extended-release injectable for treating schizophrenia.

Aristada (Aripiprazole lauroxil) is the injectable version of schizophrenia medication Abilify, a once-a-day oral treatment developed by Japanese firm Otsuka Pharmaceuticals and sold by Bristol-Myers Squibb Co. in the United States.

Aristada, poised for immediate launch, is promoted as the first atypical antipsychotic drug with once-a-month and six-week dosing options.

David Henderson, M.D., of Massachusetts General Hospital said that despite numerous medicines, schizophrenia remains a serious and debilitating condition with “significant unmet medical need and suffering.”

Schizophrenia is a severe and disabling mental disorder marked by symptoms such as hallucinations, depression, social withdrawal, and disorganized thinking. An estimated 2.4 million American adults and more than 20 million worldwide have this illness, according to the World Health Organization (WHO).

Vamil Divan, Credit Suisse analyst, estimates that sales for long-acting injectables for schizophrenia in the U.S. market will more than double by 2020 to $3 billion, with Aristada expected to maintain 16 percent market share. Thomson Reuters Cortellis said Aristada’s peak annual sales could be $550 million by 2020.

Alkermes has also expressed plans to market Aristada as a pre-filled syringe.

Aristada competes against other long-acting injectables for this health condition, including Zyprexa Relprevv from Eli Lilly and Abilify Maintena from Otsuka.

According to the press release, data from a randomized, double-blind, placebo-controlled, phase 3 study in 623 schizophrenia patients provide basis for the FDA approval of Aristada.

The results of the study, published last June 2015 in the Journal of Clinical Psychiatry, showed that the drug was “generally well tolerated” with insomnia, akathisia, and headache as the most common adverse events during the trial.

FDA’s approval of the drug, however, comes with a boxed warning that states Aristada is not approved for patients diagnosed with dementia-related psychosis. According to the warning, elderly patients with the said condition, when treated with antipsychotic medication, are at a greater risk of death.

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