Olanzapine Long-Acting Injection (LAI) Shown to Maintain Treatment Benefit in Schizophrenia for up to Six Months

BARCELONA, Spain, Sept. 2  /PRNewswire-FirstCall/ -- Final results from a 24-week study presented today at a major medical meeting in Barcelona suggest that investigational olanzapine long-acting injection (LAI) therapeutic doses showed a maintenance of treatment benefit for up to six months. A review of pooled safety data from all olanzapine LAI clinical trials was also presented at the meeting.

Olanzapine LAI is an investigational formulation that combines Zyprexa(R) (olanzapine), an atypical antipsychotic, with pamoic acid resulting in a salt that sustains the delivery of olanzapine for a period of up to four weeks. Long-acting injectable antipsychotics have been associated with improved treatment of schizophrenia in patients who have difficulty adhering to daily treatment regimens.(1)

"These studies offer insight into the role olanzapine LAI may play in the treatment of patients with schizophrenia who have benefited from olanzapine but continue to struggle with adherence," said David McDonnell, M.D., clinical research physician at Lilly. "If approved, olanzapine LAI could be a valuable treatment option due to the chronic and severe nature of schizophrenia, persistent challenges with adherence and the limited number of available depot formulations."

Independent regulatory reviews of olanzapine LAI applications are ongoing in the European Union, Canada, Australia and United States. Olanzapine LAI is currently being reviewed by CHMP and submission to regulators to obtain country-specific marketing approval is dependent upon a CHMP opinion.

  Notes for editors:

  About HGKA (24-week maintenance of effect study)


In this 24-week double-blind maintenance study, a total of 1,065 adult outpatients with schizophrenia who had been stabilized previously with open- label oral olanzapine (10, 15, or 20 mg daily) for four to eight weeks were randomized to one of three therapeutic dosing regimens of olanzapine LAI (150 mg every two weeks, 300 mg every two weeks or 405 mg every four weeks), to a low reference dose of olanzapine LAI (45 mg every four weeks), or remained on oral olanzapine at their previously stabilized dose. No supplementation with oral antipsychotics was permitted during the study.

An assessment of clinical stability was based on change in oral olanzapine dose as well as standard measures including Clinical Global Impressions- Improvement of Illness (CGI-I) and Brief Psychiatric Rating Scale (BPRS) scales. Symptom severity was assessed using the Positive and Negative Syndrome (PANSS), PANSS-derived BPRS, and the Clinical Global Impressions-Severity of Illness (CGI-S) and CGI-I scales.

Therapeutic doses of olanzapine LAI were shown to provide positive maintenance of treatment for up to six months. Mean baseline-to-endpoint changes in PANSS total scores for patients treated with therapeutic olanzapine LAI doses (150 mg every 2 weeks, 300 mg every 2 weeks and 405 mg every 4 weeks) differed significantly from those treated with the reference dose (respectively, 2.7, -2.2, -0.1, vs. 7.3; all p