The U.S. Food and Drug Administration (FDA) approved ZYPREXA RELPREVV (olanzapine) For Extended Release Injectable Suspension for the treatment of schizophrenia in adults, Eli Lilly and Company (NYSE: LLY) announced today. ZYPREXA RELPREVV, a long-acting intramuscular injection, sustains the delivery of olanzapine for up to four weeks.
Different from both oral and injected short-acting formulations, long-acting formulations of antipsychotics allow for stable concentrations of the active drug to remain at a therapeutic range for an extended period of time.
"Patients, families and communities often needlessly suffer the consequences of relapse when daily schizophrenia medications are not taken as prescribed," said John Kane, M.D., chairman, Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, N.Y. "ZYPREXA RELPREVV gives patients an additional treatment option that can help them maintain therapeutic drug levels for up to four weeks at a time."
Approximately 2.4 million Americans or about 1.1 percent of the adult population have schizophrenia. Schizophrenia is a brain disorder characterized by acute episodes of delusions (false beliefs that cannot be corrected by reason) and hallucinations (usually in the form of non-existent voices), as well as long-term impairments such as diminished emotion, general lack of interest and depressive signs and symptoms.
Proper treatment for schizophrenia can relieve symptoms, prevent or delay relapse and break the "revolving door" cycle often associated with schizophrenia. Non-adherence to antipsychotic medications greatly increases the risk of relapse in patients with schizophrenia. By administering long-acting medications, psychiatrists know when patients have received their medication and can immediately detect non-adherence when a patient does not return for a scheduled injection.
"There is a growing recognition among psychiatrists in the United States that non-adherence to medication is an even greater barrier to care for patients with schizophrenia than was previously understood, and that long-acting treatments can play a beneficial role in helping patients maintain a stable treatment regimen," said John Hayes, M.D., vice president of Lilly Research Laboratories. "ZYPREXA RELPREVV provides a new mechanism for helping appropriate patients benefit from the well-characterized efficacy of olanzapine."
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 405 mg) provide therapeutic olanzapine exposure for two or four weeks depending on the dose.
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). PDSS events include a wide range of signs and symptoms of sedation, from mild in severity to coma, and/or delirium, including confusion, disorientation, agitation, anxiety or other cognitive impairment. As of November 30, 2009, across all clinical trials, PDSS events have occurred in < 0.1 percent of injections and approximately 2 percent of patients. The potential for onset of an event is greatest within the first hour after injection. The majority of cases have occurred within the first three hours after injection; however cases have occurred after three hours. All patients largely recovered within 72 hours, and the majority of these patients have chosen to continue treatment with ZYPREXA RELPREVV. Labeling for ZYPREXA RELPREVV includes a requirement for the patient to be observed at a healthcare facility with ready access to emergency response services for at least three hours following each injection and to be accompanied to his or her destination upon leaving the facility.
Lilly worked with the FDA to develop a Risk Evaluation and Mitigation Strategy (REMS), which includes a communication plan, a patient medication guide and a mandatory Patient Care Program, which restricts distribution of ZYPREXA RELPREVV to prescribers, healthcare facilities, pharmacy service providers and patients enrolled in the program. The goal of the Patient Care Program is to mitigate the risk of negative outcomes associated with ZYPREXA RELPREVV PDSS.
This treatment has been approved in the European Union under the trade name Zypadhera(TM) and in New Zealand and Australia under the trade name ZYPREXA RELPREVV.
SOURCE Eli Lilly and Company