Fanapt® significantly improved overall schizophrenia symptoms as measured by PANSS1,2

Improvement in symptoms in a 4-week study2
Fanapt Efficacy PANSS Data Graph

 

  • In this study, Fanapt® (iloperidone) demonstrated similar efficacy to ziprasidone, which also required a slow titration to the target dose1
Study design: 4-week, placebo- and active-controlled trial (n=604) involved one fixed dose of Fanapt® (24 mg/day) compared to placebo- and an active-control (ziprasidone). The titration was similar to that of the 6-week study. Fanapt® was titrating at 1 mg twice daily on Day 1, and the dose was increased to 2, 4, 6, 8, 10, and 12 mg twice daily on Days 2, 3, 4, 5, 6, and 7, respectively. The primary endpoint was change from baseline on the PANSS total score at the end of treatment (Day 28) analyzed using mixed-effects model repeated measures (MMRM). Mean baseline scores were 92.88 for Fanapt® and 90.48 for placebo.1,3
PANSS-T = Positive and Negative Syndrome Scale total score.

 

Fanapt® significantly improved overall schizophrenia symptoms as measured by BPRS1,3

Improvement in symptoms in a 6-week study3
efficacy-improvement-chart

 

Study design: 6-week, placebo- and active-controlled trial (n=706) involving 2 flexible dose ranges of Fanapt® (12 to 16 mg/day or 20 to 24 mg/day) compared to placebo and an active-control (risperidone). Fanapt® was titrated to the respective dose over a period of 7 days. The primary endpoint was change from baseline on the BPRS total score at the end of treatment (Day 42).1
Patients taking Fanapt® at both high and low doses demonstrated significant reductions from baseline in BPRS score at Day 421:
  • The active-control antipsychotic drug (risperidone) appeared to be superior to Fanapt® in this trial within the first 2 weeks, a finding that may in part be explained by the more rapid titration that was possible for that drug. In patients in this study who remained on treatment for at least 2 weeks, iloperidone appeared to have had comparable efficacy to the active control (risperidone)
BPRS = Brief Psychiatric Rating Scale; LOCF = Last observation carried forward.
Fanapt® demonstrated efficacy with placebo-like rates of akathisia.1
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References: 1. Fanapt [package insert]. Washington, DC: Vanda Pharmaceuticals, Inc.: 2016. 2. Cutler AJ, Kalahi AH, Weiden PJ, Hamilton J, Wolfgang CD. Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S20-S28. 3. Data on File, Vanda Pharmaceuticals, Inc.

RELAPSE PREVENTION

FANAPT® DEMONSTRATED LONG-TERM EFFICACY BY DELAYING TIME TO RELAPSE
FANAPT® DEMONSTRATED EFFICACY FOR LONG-TERM MAINTENANCE TREATMENT OF SCHIZOPHRENIA

KAPLAN MEIER ESTIMATION OF PERCENT RELAPSE/IMPENDING RELAPSE FOR FANAPT® AND PLACEBO-TREATED PATIENTS1*
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(log rank test: P<.0001)
*Based on final analysis dataset.


  • BASED ON THE INTERIM ANALYSIS, THE MEAN TIME TO RELAPSE WAS 139 DAYS FOR FANAPT® VS 71 DAYS FOR PLACEBO4*
  • AFTER 6 MONTHS, 79.6% OF PATIENTS TAKING FANAPT® DID NOT RELAPSE VS 36.6% ON PLACEBO, BASED ON THE INTERIM ANALYSIS4
  • NO NEW SAFETY SIGNALS COMPARED TO THOSE OBSERVED IN SHORT-TERM STLIDIES4
  • FLEXIBLE DOSING OF FANAPT® (8-24 MG/DAY) WAS EFFECTIVE1
*Relapse or impending relapse is defined as any of the following: hospitalization due to worsening of schizophrenia; increase
(worsening) of the PANSS score ≥30%; CGI-improvement score of ≥6; patient had suicidal, homicidal, or aggressive behavior;
CGI, Clinical Global Impression.

IMPORTANT SAFETY INFORMATION

Neuroleptic malignant syndrome, a potentially fatal symptom, has been reported in association with antipsychotic drugs, including Fanapt®. Manage with immediate discontinuation of drug, treatment if needed, and close monitoring.

Tardive dyskinesia: The risk of tardive dyskinesia may increase as the duration of treatment and total cumulative dose increases. Discontinue Fanapt® if clinically appropriate.

Seizures: Use Fanapt® cautiously in patients with a history of seizures or with conditions that lower seizure threshold.

Falls: Fanapt® may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls causing fractures or other injuries. For patients with diseases, conditions or medications that could exacerbate these effects, complete fall risk assessments initially and recurrently during therapy.

Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotics. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue Fanapt at the first sign of a decline in WBC in the absence of other causative factors.


Study design: A double-blind, placebo-controlled, randomized withdrawl study (n=303) involving a flexible-dose range of Fanapt® (8-24 mg/day) administered as twice-daily doses. The study consisted of a 7-day titration period where Fanapt® was titrated at 1 mg twice daily on day 1,2 mg twice daily on day 2,4 mg twice daily on day 3,6 mg twice daily on day 4, 5, 6 and 7, followed by a stabilization period lasting at least 12 weeks. During the subsequent double-blind relapse prevention phase lasting up to 26 weeks, patients were randomized to placebo or established dose of Fanapt® and observed for relapse or impending relapse. Stablization was defined as being on an established dose of Fanapt® that was unchanged due to efficacy in the 4 weeks prior to randomization, having a CGI-Severity score ≤4 and PANSS score ≤70, a score of ≤4 on each of the following individual PANSS items (P1-delusions, P2-conceptual disorganization, P3-hallucinatory behavior, P6-suspiciousness/persecution, P7-hostility, or G8- uncooperativeness), and no hospitalization or increase in level of care to treat exacerbations. The primary endpoint was time to relapse or impending relapse compared to placebo, defined as any of the following: hospitalization due to worsening of schizophrenia; increase (worsening) of PANSS score of ≥30%; CGI-Improvement score ≥6; patient had suicidal, homicidal, or aggressive behavior; or need for any other antipsychotic medication, including increase in study medication.