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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  03/12/2015
Trade Name:  Saphris
Generic Name or Proper Name (*):  asenapine
Indications Studied:  Treatment of Schizophrenia and Acute Manic or Mixed Episodes Associated with Bipolar I Disorder
Label Changes Summary:  *Bipolar I Disorder *Safety and efficacy were established in a 3-week, placebo-controlled, double-blind trial of 403 pediatric patients ages 10 to 17 years, at fixed doses ranging from 2.5 mg – 10 mg twice daily *Safety and efficacy in patients less than 10 years of age have not been evaluated *In a Phase 1 study, pediatric patients aged 10 to 17 years appeared to be more sensitive to dystonia when the recommended dose escalation schedule for initial dosing was not followed *Adverse reactions: somnolence, dizziness, dysgeusia, oral paresthesia, nausea, increased appetite, fatigue, increased weight. Fatigue dose related *Monitor weight compared to expectations for normal growth. Weight gain (greater than or equal to 7%. increase in body weight) higher than placebo , Saphris 2.5 mg twice daily, 5 mg twice daily and 10 mg twice daily (1.1%, 12%, 8.9% and 8 % respectively) *No additional new major safety findings were reported from a 50-week, open-label, uncontrolled safety *Safety and efficacy for adjunctive therapy in the treatment of bipolar I disorder have not been established in the pediatric population. *Schizophrenia *Efficacy was not demonstrated in an 8-week, placebo-controlled, double-blind trial, in 306 adolescent patients aged 12 to17 years with schizophrenia *Safety and efficacy in patients less than 12 years have not been evaluated, *The most common adverse reactions reported were somnolence, akathisia, dizziness, and oral hypoesthesia or paresthesia. * Monitor weight gain compared with tht expected for normal growth. Increases in body weight of at least 7% increase in body weight at endpoint compared to baseline for placebo, Saphris 2.5 mg twice daily, and Saphris 5 mg twice daily was 3%, 10%, and 10%, respectively *Adverse reactions identified in the pediatric schizophrenia trial were generally similar to those observed in the pediatric bipolar and adult bipolar and schizophrenia trials *No new major safety findings were reported from a 26-week, open-label safety trial in pediatric patients with schizophrenia treated with Saphris monotherapy *Information on dosing, adverse reactions, lab abnormalities, and clinical trials *Postmarketing study
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Forest
Pediatric Exclusivity Granted Date:  03/03/2015
Therapeutic Category:  Antipsychotic