Ireland-based Alkermes’ new drug application (NDA) for Aripiprazole Lauroxil NanoCrystal Dispersion (ALNCD) to treat patients with schizophrenia has been accepted for filing by the US Food and Drug Administration (FDA).

The company can file NDA for ALNCD, a new investigational product, designed for initiation onto Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.

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Schizophrenia is a chronic, severe and disabling brain disorder marked by positive symptoms such as hallucinations and delusions, and negative symptoms, such as depression, blunted emotions and social withdrawal.

The disease also results in disorganised thinking in the affected person.

“The acceptance of this filing marks a significant milestone as we seek approval for ALNCD as a novel product designed for initiation onto Aristada for the treatment of schizophrenia.”

Aristada is an injectable atypical antipsychotic approved in four doses and three dosing durations to treat patients with Schizophrenia.

Alkermes Research and Development executive vice-president Dr Elliot Ehrich said: “The acceptance of this filing marks a significant milestone as we seek approval for ALNCD as a novel product designed for initiation onto Aristada for the treatment of schizophrenia.

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“We look forward to working with the agency in the coming months with the goal of bringing this potential new initiation product for Aristada to healthcare providers and their patients as quickly as possible.”

If approved, administration of ALNCD in combination with a single oral dose of 30mg of aripiprazole will replace the use of three weeks of concomitant oral aripiprazole with the first dose of Aristada.

The target action date by the US FDA for the ALNCD NDA will be 30 June next year.