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ALPINE: A PHASE 3B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY1

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)§

STUDY DESIGN1

Placebo intramuscular (IM) injections and an oral placebo were given to maintain blinding.

aARISTADA INITIO is a onetime initiation IM injection.

  • The study was not designed to compare efficacy or safety between groups1
  • 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.

Reduction in PANSS total score from baseline was observed for the treatment group receiving ARISTADA INITIO and the ARISTADA 2-month dose (1064 mg)1

PRIMARY ENDPOINT1

  • There was improvement from baseline to Week 4 for each treatment group
  • Mean change from baseline in PANSS total score was -17.4 for ARISTADA

SECONDARY ENDPOINTS1

  • Within-group reductions in change from baseline in PANSS total scores were observed during the 25-week study for each treatment group

MEAN CHANGE FROM BASELINE IN PANSS TOTAL SCORE (WITHIN GROUP)1

This was not a head-to-head study. This study was not powered to provide comparative efficacy or safety results and should not be interpreted as suggesting ARISTADA as superior or noninferior to INVEGA SUSTENNA.1

EVALUATION OF PATIENT CONTINUATION AND SAFETY/TOLERABILITY1

  • Additional laboratory values were measured1

aPatients with a week 4 PANSS assessment.

bAll AEs reported during treatment while in the study.

cShown in descending order of incidence.

This was not a head-to-head study. This study was not powered to provide comparative efficacy or safety results and should not be interpreted as suggesting ARISTADA as superior or noninferior to INVEGA SUSTENNA.1

Reduction in PANSS total score from baseline was observed for the treatment group receiving INVEGA SUSTENNA 156 mg every month1

PRIMARY ENDPOINT1

  • There was improvement from baseline to Week 4 for each treatment group
  • Mean change from baseline in PANSS total score was -20.1 for INVEGA SUSTENNA® (paliperidone palmitate)

SECONDARY ENDPOINTS1

  • Within-group reductions in change from baseline in PANSS total scores were observed during the 25-week study for each treatment group

MEAN CHANGE FROM BASELINE IN PANSS TOTAL SCORE (WITHIN GROUP)1

This was not a head-to-head study. This study was not powered to provide comparative efficacy or safety results and should not be interpreted as suggesting ARISTADA as superior or noninferior to INVEGA SUSTENNA.1

EVALUATION OF PATIENT CONTINUATION AND SAFETY/TOLERABILITY1

  • Additional laboratory values were measured1

aPatients with a week 4 PANSS assessment.

bAll AEs reported during treatment while in the study.

cShown in descending order of incidence.

This was not a head-to-head study. This study was not powered to provide comparative efficacy or safety results and should not be interpreted as suggesting ARISTADA as superior or noninferior to INVEGA SUSTENNA.1

See how to start your patients on ARISTADA with the ARISTADA INITIO regimen

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References: 1. Data on file. Alkermes, Inc. 2. ARISTADA [package insert]. Waltham, MA: Alkermes, Inc; 2019. 3. ARISTADA INITIO [package insert]. Waltham, MA: Alkermes, Inc; 2019. 4. Leucht S, Kane JM, Kissling W, Hamann J, Etschel E, Engel RR. What does the PANSS mean? Schizophr Res. 2005;79(2-3):231-238.