FDA clears Alkermes’ long-acting antipsychotic
US regulators, FDA have approved a new long-acting, injectable antipsychotic with a range of dosing strengths and regimens designed to address the individual treatment requirements of patients with schizophrenia.
Alkermes’ Aristada (aripiprazole lauroxil) is the first atypical antipsychotic that has both once-monthly and six-week dosing options, green-lighted by the FDA.
The company states that Aristada’s long-lasting action provides patients with blood concentrations of active drug that remain within a therapeutic range for an extended period of time, whilst also helping healthcare professional’s better track adherence to therapy.
Furthermore, clinical evidence shows that long-acting antipsychotics have a significant clinical impact for patient outcomes, helping to reduce hospitalisations, achieve better remission rates, and improve patient scores in disease severity, the firm previously said.
Approval was based on data from a Phase III study in 623 patients, showing that across various dose strengths the drug induced significant and clinically meaningful reductions in Positive and Negative Syndrome Scale scores (used for measuring symptom severity in schizophrenia) at Week 12, thereby meeting the trial’s primary endpoint.
The most common adverse symptoms reported during the study were insomnia, akathisia and headache, the firm noted.
An estimated 2.4 million American adults have schizophrenia; Alkermes said it is preparing to launch Aristada immediately.