Alkermes releases positive results for schizophrenia drug Aristada

Phase IIIb clinical trial results from the ALPINE study, evaluating Ireland-incorporated Alkermes’ (Nasdaq: ALKS) Aristada (aripiprazole lauroxil) and Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Pharmaceuticals' Invega Sustenna (paliperidone palmitate) in 200 patients experiencing acute exacerbations of schizophrenia showed comparable efficacy with similar safety profiles.

"The ALPINE study showed that both Aristada, given every two months, and Invega Sustenna, given every month, demonstrated statistically-significant improvements from baseline in schizophrenia symptoms, and that the efficacy was similar for both medicines throughout the six-month study. This research provides evidence that these two long-acting medicines, each with their own distinct safety and tolerability profile, may be clinically useful in helping to bridge the critical transition between inpatient and outpatient settings of care," said Dr Craig Hopkinson, chief medical officer at Alkermes.

"These data underscore that Aristada Initio along with the two-month dose of Aristada together represent a novel approach to treatment initiation and a compelling clinical option for patients and healthcare professionals alike. The ALPINE study illustrates Alkermes' commitment to expanding the body of evidence for schizophrenia treatment and developing important medicines that help meet critical unmet needs in patient care," he added.