Eli Lilly has reported that the FDA has approved Zyprexa Relprevv (Olanzapine) for extended release injectable suspension for the treatment of schizophrenia in adults. Zyprexa Relprevv, a long-acting intramuscular injection, sustains the delivery of Olanzapine for up to four weeks.
The FDA approval is based on a broad clinical data package involving 2,054 patients, in which Zyprexa Relprevv was found to be effective in controlling symptoms of schizophrenia, including hallucinations, delusions, apathy and social withdrawal. Efficacy was shown without the need for oral supplementation.
Clinical data showed that Zyprexa Relprevv dosages (150, 210, 300 and 405mg) provide therapeutic Olanzapine exposure for two or four weeks depending on the dose.
The company said that Zyprexa Relprevv was found to have a similar safety profile as oral Olanzapine, with the exception of injection-related events, including post-injection delirium/sedation syndrome (PDSS).
John Kane, chairman of department of psychiatry at the Zucker Hillside Hospital, Glen Oaks, said: “Patients, families and communities often needlessly suffer the consequences of relapse when daily schizophrenia medications are not taken as prescribed. Zyprexa Relprevv gives patients an additional treatment option that can help them maintain therapeutic drug levels for up to four weeks at a time.”