Sunovion Pharmaceuticals Inc. today announced results from an open-label
study that switched clinically stable, but symptomatic adult outpatients
with schizophrenia from other antipsychotic agents to LATUDA (lurasidone
HCl) . These data were presented at the 165th
Annual Meeting of the American Psychiatric Association in Philadelphia,
Pennsylvania.
This 6-week open-label study included 244 patients who were clinically
stable for at least eight weeks prior to the start of the study and had
been on stable doses of other antipsychotic agents for at least four
weeks. The study's primary endpoint was time to treatment failure
(defined as discontinuation due to insufficient clinical response or an
adverse event, including exacerbation of underlying disease). In
addition, the study was intended to assess the safety and tolerability
of switching patients from other antipsychotic agents to LATUDA.
Eligible patients were randomized to one of three LATUDA dosing regimens
for the initial two weeks of the study: 1) 40 mg/day for two weeks; 2)
40 mg/day for one week, then an increase to 80 mg/day on Day 8 for Week
2 (uptitration group); and 3) 80 mg/day for two weeks. LATUDA was then
flexibly dosed (40-120 mg/day) for the subsequent four weeks of the
study across each of the three dosing regimens. The pre-switch
antipsychotic agent was tapered by Day 7 to 50% of the original dose and
discontinued by the end of Week 2.
The proportion of patients across all LATUDA doses (19/240, 7.9%) that
met pre-specified criteria for treatment failure (based on initial
randomized dose groups) was as follows:
-
LATUDA 40 mg/day: 6.9% (5/72)
-
LATUDA 40/80 mg/day (uptitration group): 9.2% (8/87)
-
LATUDA 80 mg/day: 7.4% (6/81)
The overall discontinuation rate was 18.9%, with 1.2% of patients
discontinuing treatment due to insufficient clinical response and 6.6%
due to adverse events.
For patients who were taking concomitant antidepressants, mood
stabilizers or antipsychotics at study initiation, approximately half
(49.5%) of these patients discontinued use of the concomitant agent by
study termination.
Adverse events (at least 5% in all LATUDA doses) observed in this study
included nausea, insomnia, akathisia, headache, vomiting, somnolence and
dry mouth. Results for all LATUDA-treated patients were as follows: