ALPINE: A PHASE 3B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND,
The approval of ARISTADA® (aripiprazole lauroxil) was based on the
phase 3 12-week pivotal study that compared 441 mg and 882 mg monthly doses to placebo at day 85. The phase 3 study showed a reduction in schizophrenia symptoms.2 ARISTADA INITIO® (aripiprazole lauroxil) and the ARISTADA 1064 mg 2-month dose were approved by the FDA based on pharmacokinetic data.2,3 This post-marketing study provided clinical data on the use of the ARISTADA INITIO regimen* and ARISTADA 1064 mg.1
This study, known as ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), is a post-marketing study that evaluated the efficacy and safety of the ARISTADA INITIO regimen and the 2-month dose of ARISTADA (1064 mg) or INVEGA SUSTENNA® (paliperidone palmitate).1-3
Primary objective: To evaluate the efficacy of ARISTADA INITIO† plus 30 mg of oral aripiprazole and ARISTADA 1064 mg during the first 4 weeks of treatment in adult patients hospitalized for an acute exacerbation of schizophrenia.1
PRIMARY EFFICACY ENDPOINT1
- Change in PANSS total score from baseline to Week 4 (within group)‡
SECONDARY EFFICACY ENDPOINTS1
- Change in PANSS total score from baseline to Week 9 and Week 25 (within group)‡
- Change in PANSS total score at Weeks 4, 9, and 25 between the 2 treatment groups (between group)§
- INVEGA SUSTENNA, a known and effective treatment, served as an active control. An active drug with a known efficacy profile is a useful method for evaluating new drugs while avoiding the ethical dilemmas associated with placebo1
- The study was not designed to compare efficacy or safety between groups1
- Patients were hospitalized with an acute exacerbation of schizophrenia and considered markedly ill, with mean PANSS total scores at baseline of 94.1 (ARISTADA) and 94.6 (INVEGA SUSTENNA)1,4
- Prior to the study, 31% of the subjects had a history of exposure to risperidone/paliperidone only, 6% of the subjects had a history of exposure to aripiprazole only, 50% of the subjects had a history of exposure to both, and 13% of the subjects had no exposure to either of the antipsychotics1
- Patients had to have a history of tolerated use of aripiprazole or risperidone/paliperidone, or demonstrated tolerability to perspective oral test doses during study screening1
*The ARISTADA INITIO regimen is defined as a single injection of ARISTADA INITIO (675 mg) given in conjunction with a single 30 mg dose of oral aripiprazole.
†ARISTADA INITIO was approved by the FDA through a single pharmacokinetic bridging study.
‡Within group: the separate assessment of each treatment group in the change from baseline in PANSS total score at Weeks 4, 9, and 25.
§Between group: the assessment of the difference in PANSS total score between treatment groups at Weeks 4, 9, and 25.