Alkermes plc announced that data from its phase IIIb ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness) study were published in the Journal of Clinical Psychiatry .
ALPINE was a six-month study evaluating the
efficacy and safety of the Aristada Initio (aripiprazole lauroxil) one-day initiation regimen, consisting of Aristada Initio and one single dose of 30 mg of oral aripiprazole, together with the Aristada (aripiprazole lauroxil) two-month dose in patients experiencing an acute exacerbation of schizophrenia. Positive topline data were first reported in April 2019. Results from the study provide evidence to support the use of the Aristada Initio one-day regimen together with Aristada for treatment of an acute exacerbation of schizophrenia, started in the hospital setting and continued through the critical transition to outpatient care.
ALPINE was a multi-center, randomized, double-blind, phase IIIb study designed to examine the efficacy and safety of using either Aristada (aripiprazole lauroxil) or Invega Sustenna (paliperidone palmitate) to start treatment in hospitalized patients experiencing an acute exacerbation of schizophrenia and continue them on treatment during the transition to outpatient care for ongoing continuation phase therapy. Positive and Negative Syndrome Scale (PANSS) total scores at Week 4, Week 9 and Week 25 were prespecified outcomes. Patients randomized to the Aristada treatment group were initiated using the Aristada Initio regimen on day 1, followed by Aristada (1064 mg) on day 8 and every two months thereafter. Patients randomized to the Invega Sustenna treatment group were initiated using a loading dose of Invega Sustenna (234 mg) on day 1, followed by Invega Sustenna (156 mg) on day 8 and every month thereafter. The inclusion of the Invega Sustenna arm provided an active control for Aristada while avoiding the use of a placebo in patients with schizophrenia.
“Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care-:Phase III, Randomized, Double-Blind, Active-Control ALPINE Study”- Peter J. Weiden, MD; Amy Claxton, PhD; Jelena Kunovac, MD; David P. Walling, PhD; et al.,.-J Clin Psychiatry. 2020;81(3):19m13207..