Alkermes Announces Positive Topline Results From Innovative Study of ARISTADA® and INVEGA SUSTENNA® for the Treatment of Schizophrenia

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[{"type":"text","content":"DUBLIN, April 9, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced positive topline results from ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), a first-of-its-kind, six-month study evaluating the efficacy, safety and tolerability of ARISTADA® (aripiprazole lauroxil) and INVEGA SUSTENNA® (paliperidone palmitate) when used to initiate patients experiencing an acute exacerbation of schizophrenia in the hospital and maintain treatment in an outpatient setting. Patients randomized to the ARISTADA treatment group were initiated using the ARISTADA INITIO® regimen* followed by ARISTADA (1064 mg) every two months. Patients randomized to the INVEGA SUSTENNA treatment group were initiated using a loading dose of INVEGA SUSTENNA (234 mg) followed by INVEGA SUSTENNA (156 mg) every month. \n\"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 Craig Hopkinson, M.D., 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.\"\nThe ALPINE study met its pre-specified primary endpoint, demonstrating that both ARISTADA and INVEGA SUSTENNA had statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) total scores from baseline at Week 4 (ARISTADA group: -17.4 points, p<0.001; INVEGA SUSTENNA group: -20.1 points, p<0.001). Additionally, PANSS total scores continued to improve at Week 9 and Week 25, the study's pre-specified secondary endpoints (ARISTADA gro...

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