Regulatory Affairs

FDA approves two-month dosing option of Alkermes’ Aristada for schizophrenia

PBR Staff Writer Published 07 June 2017

Alkermes has secured approval from the US Food and Drug Administration (FDA) for a two-month dosing option of Aristada to treat schizophrenia.

Aristada is an extended-release injectable atypical antipsychotic which after entering into the body gets converted to aripiprazole.

The atypical antipsychotic has now been approved by FDA in four doses and three dosing duration options. Alkermes said it can be initiated by healthcare providers at any dose or interval.

Overall, Aristada’s approvals from the FDA cover for once-monthly, once-every-six-weeks and once-every-two-months dosing options.

Alkermes research and development executive vice president Elliot Ehrich said: “We designed Aristada to offer flexibility to meet the real-world needs of patients suffering from schizophrenia and the healthcare professionals providing their care.

“As the first and only long-acting atypical antipsychotic approved in three dosing durations and with the ability to initiate treatment at any dose or duration, Aristada provides a range of options to help clinicians tailor treatment to the individual needs of their patients.”

Following the approval of the two-month dosing option, schizophrenia patients in the US now have the opportunity to have their symptoms treated with only six injections in a year.

Further, it also eliminates the need for daily or regular therapy for schizophrenia patients for whom it is a challenge when it comes to adhering to treatment. Alkermes says that a long-acting injectable medication like Aristada takes off the burden of administering an oral antipsychotic medicine to schizophrenia patients on a daily basis.

The Irish biopharma is set to launch the two-month dose of Aristada in the course of this month.

The FDA originally approved Aristada in October 2015. Alkermes said on its website that it is not known if Aristada is safe and effective in children under 18 years of age.