FDA approves new generic version of schizophrenia treatment

Alkermes Plc. (ALKS) said the U.S. Food and Drug Administration has approved ARISTADA (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. Aristada, poised to be launched immediately, will offer once-a-month and six-week dosing options. In addition, the approval for Aristada covers schizophrenia only.

David Henderson, MD, of Psychiatry at Massachusetts General Hospital, shared that long-acting therapies are rapidly evolving these days for the treatment of treatment of schizophrenia. Abilify has indications beyond schizophrenia, including major depressive disorder and bipolar-mania disorder. It was approved in the E.U.in 2004, and went on to become a blockbuster antipsychotic in the global market with sales consistently above the $6 billion mark at its height.

Alkermes believes Aristada is different enough that it will stand out, though.

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

The FDA made the approval based on studies that proved the safety and efficacy of the drug, analyzing data from several studies conducted on 623 patients with schizophrenia, demonstrating its effectiveness.

A couple of notes: Aristada is not approved to treat patients with dementia-related psychosis.

In the trial, the most common side effect reported by participants was akathisia, or the urge to move constantly, according to the FDA. According to the warning, elderly patients with the said condition, when treated with antipsychotic medication, are at a greater risk of death.