FDA Approves Two Extended-Release Drugs for Schizophrenia

The FDA has approved Otsuka and Lundbeck’s NDA for Abilify Asimtufii (aripiprazole) extended-release intramuscular injectable drug to treat adult patients with schizophrenia or as maintenance monotherapy treatment in adults with bipolar I disorder.

The agency also approved Teva and MedinCell’s Uzedy (risperidone) extended-release subcutaneous injectable in adults with schizophrenia.

Both approved drugs come in the form of pre-filled syringes.

Abilify Asimtufii can maintain therapeutic plasma concentrations for two months with one dose.

Uzedy can lead to therapeutic blood concentrations within six to 24 hours following a single dose and is given in one or two-month dosing intervals. Clinical trial results showed an 80 percent reduction in relapse, the companies said.

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