Ireland’s Alkermes has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for a new investigational product, Aripiprazole Lauroxil NanoCrystal Dispersion (ALNCD), for initiation onto Aristada (aripiprazole lauroxil) to treat schizophrenia.
With the firm’s NanoCrystal technology, ALNCD is engineered to deliver the formulation of extended-release injectable suspension of aripiprazole lauroxil using a smaller particle size compared to that of Aristada.
This mechanism is intended to quickly achieve therapeutic levels of aripiprazole by allowing fast dissolution.
Upon approval of the NDA, the combination of ALNCD and single oral dose of 30mg aripiprazole is expected to replace the three weeks of concomitant oral aripiprazole required with the first dose of Aristada.
Alkermes Research and Development executive vice-president Elliot Ehrich said: “The ability to initiate long-acting treatment with Aristada on day one without the need to continue oral supplementation during this critical transition period may be a useful and welcomed option for the clinical community.
“Aristada is designed to offer flexibility to meet the real-world needs of patients in both inpatient and outpatient settings.”
Aristada is an atypical antipsychotic that converts into aripiprazole inside the body. The drug is currently approved for the treatment of schizophrenia in four doses and three dosing durations.
ALNCD is meant for initiation onto all doses and durations of Aristada, comprising 441mg, 662mg and 882mg monthly, 882mg once every six weeks and 1,064mg once every two months.