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100
What does BPRS stand for?
Brief Psychiatric Rating Scale
100
What is the maximum recommended daily dose of Fanapt?
24 mg/day
100
What tablet strengths of Fanapt are available?
1, 2, 4, 6, 8, 10, 12
100
What is the half-life of Fanapt in the general population?
18 hours
100
How should Fanapt be administered with regard to food?
Without regard to meals
200
What are the receptors for which Fanapt has high affinity?
5HT2a, D2, D3, and NEα1
200
Which main enzymes metabolize Fanapt?
CYP2D6 & CYP3A4
200
If a patient is coadministered a CYP2D6 and/or CYP3A4 inhibitor, should the dose of Fanapt be adjusted and if so, how?
Yes, decreased by half
200
Across all short- and long-term studies mentioned in the label, the overall mean change in weight with Fanapt from baseline to endpoint was what?
2.1 kg
200
What is the proposed mechanism of action of Fanapt?
D2/5HT2 antagonist
300
What were the 2 active controls used in the pivotal Phase III trials with Fanapt?
risperidone and ziprasidone
300
What does PANSS stand for?
The Positive and Negative Syndrome Scale
300
The long-term efficacy of Fanapt was demonstrated in what type of study?
A long-term, placebo-controlled randomized withdrawal study.
300
List at least 3 of the most commonly observed adverse reactions that occurred in >=5% of the patients treated with Fanapt and at least twice the placebo rate for at least 1 dose.
dizziness, dry mouth, fatigue, nasal congestion, somnolence, tachycardia, orthostatic hypotension, weight increased
300
Who was first author on the REPRIEVE manuscript?
Peter J Weiden
400
What are the symptoms of akathisia?
Inward symptoms, such as inner restlessness, agitation, and anxiety as well as outward symptoms such as an inability to stay seated.
400
Fanapt doses shown to have superiority to placebo on either the PANSS or BPRS scales in 4- to 6-week studies are_____.
12 mg/day, 16 mg/day, 20 mg/day, 24 mg/day
400
Why is it thought that one of the active-controls used in one of the short-term pivotal studies appeared to be superior to Fanapt within the first 2 weeks?
Because of the more rapid titration that was possible for that drug.
400
Describe the studies used to support the short-term efficacy of Fanapt.
4- and 6-week, double-blind, placebo-and active-controlled studies
400
What mean baseline PANSS scores were required for inclusion in the two short-term studies?
60 for the 6-week study and 70 for the 4-week study
500
What doses were used to assess the long-term maintenance efficacy of Fanapt?
8-24 mg/day
500
What is the long-term maintenance study referred to as?
REPRIEVE
500
What was the primary efficacy variable used to establish long-term maintenance of Fanapt?
Time to relapse or impending relapse
500
Name one criteria used to define relapse or impending relapse?
Hospitalization due to worsening of schizophrenia, increase of the PANSS total score >=30%, CGI-Improvement score >=6, patient had suicidal, homicidal, or aggressive behavior, or need for any other antipsychotic medication, including increasing dose of study medication.
500
What is the name of the type of graph used in the label to display the long-term efficacy of Fanapt?
A Kaplan Meier or Survival Curve