Lurasidone hydrochloride (Latuda) management of manifestations of schizophrenia
The basis of the resubmission is: an indirect comparison (IDC) of lurasidone, aripiprazole, and ziprasidone; an open-label study of patients switched to lurasidone from another antipsychotic; the publication of Study 234, an open-label extension study of Study 233 (reviewed as a Supplemental Issue i...
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| Format: | eBook |
| Language: | English |
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Ottawa (ON)
Canadian Agency for Drugs and Technologies in Health
2014, 2014
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| Series: | Common drug review clinical review report
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| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | The basis of the resubmission is: an indirect comparison (IDC) of lurasidone, aripiprazole, and ziprasidone; an open-label study of patients switched to lurasidone from another antipsychotic; the publication of Study 234, an open-label extension study of Study 233 (reviewed as a Supplemental Issue in the original CDR review based on unpublished information); Study 231E, an open-label extension of Study 231; and a lower confidential price Seven of the trials were placebo-controlled, acute-treatment trials of six weeks duration designed to assess the efficacy of various doses of lurasidone ranging from 20 mg to 160 mg daily (Studies: 6 [N = 149], 196 [N = 180], 229, [N = 500], 231 [N = 478], 233 [N = 488], 2 [N = 460], and 49 [N = 356]). The remaining two trials (Study 237 and Study 254) were performed in stable patients. Four of the acute-treatment trials (Studies 2, 49, 231, and 233) included active comparators to verify assay sensitivity, but none were designed to compare lurasidone with the active treatments. In May 2013, the manufacturer resubmitted lurasidone seeking a listing recommendation for the acute treatment of schizophrenia. Lurasidone (Latuda) is an atypical antipsychotic (AAP) indicated for the management of patients with clinical manifestations of schizophrenia. The manufacturer has submitted a resubmission requesting reimbursement for the 40 mg, 80 mg, and 120 mg strengths for the management of the manifestations of schizophrenia; the original approved indication and listing request for lurasidone when the drug was initially submitted to the Common Drug Review (CDR) in 2012 was for the acute treatment of patients with schizophrenia. In January 2013, the Canadian Drug Expert Committee (CDEC) issued a recommendation that lurasidone not be listed. The key reason for the recommendation was a lack of evidence from randomized controlled trials (RCTs) to establish the comparative efficacy of lurasidone relative to other AAPs for the acute treatment of schizophrenia. The original CDR review included nine RCTs investigating the efficacy and safety of lurasidone for the treatment of schizophrenia. |
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| Item Description: | Title from title screen |
| Physical Description: | 1 online resource illustrations |