Olanzapine Long-Acting Injection (LAI) Shown to Maintain Treatment Benefit in Schizophrenia for up to Six Months
September 02 2008 - 8:19AM
PR Newswire (US)
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