Highlights
- •Pregabalin as a first-line therapy for peripheral neuropathic pain.
- •Lyrica Capsule administered as 2 doses per day (150-600 mg/day).
- •GLA5PR GLARS-NF1 Tab. (150 mg and 300 mg) as an extended-release pregabalin formulation for once-daily intake.
- •The effectiveness and safety of GLA5PR GLARS-NF1 Tab. for peripheral neuropathic pain.
- •Once-daily administration, treatment effect by improved treatment compliance.
Abstract
Purpose
This study compared the efficacy and safety of controlled-release pregabalin (GLA5PR
GLARS-NF1 tablets) with those of an immediate-release pregabalin capsule after 12
weeks' administration to patients with peripheral neuropathic pain.
Methods
In this multicenter, randomized, double-blind, active-controlled, parallel-group,
Phase III study, the primary outcome was to confirm that a single treatment with the
study drug (after the evening meal) is clinically noninferior to the control drug
(BID regimen) at improving the mean Daily Pain Rating Scale score for treating peripheral
neuropathic pain. Secondary outcomes were the Daily Sleep Interference Scale, Medical
Outcomes Study Sleep Scale, Hospital Anxiety and Depression scale, and frequency of
rescue medication use. The safety and tolerability of GLA5PR GLARS-NF1 tablets were
also evaluated. The total daily dose of pregabalin is 150–600 mg.
Findings
Of the 352 randomized subjects, 261 (n = 130, study group; n = 131, control group)
were analyzed. The difference in adjusted mean Daily Pain Rating Scale scores between
the groups was −0.11 (95% confidence interval, −0.05 to 0.30), indicating that the
study group is noninferior to the control group. There was no statistically significant
difference in Daily Sleep Interference Scale, Medical Outcomes Study Sleep Scale,
and Hospital Anxiety and Depression scale scores between the groups at treatment termination.
Logistic regression analysis revealed no significant difference in the use of rescue
medication between the groups (P = 0.217). The overall adverse event profile of the groups was similar, and no serious
adverse drug reactions were observed.
Implications
GLA5PR GLARS-NF1 tablets can be effectively and safely administered to patients with
peripheral neuropathic pain. Furthermore, we found that sleep, anxiety, and depression
were improved with pain control. Owing to the once-daily administration, treatment
effects can be maximized by improved treatment compliance. ClinicalTrials.gov identifier: NCT03221907.
Key words
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Article info
Publication history
Published online: November 30, 2020
Accepted:
October 21,
2020
Identification
Copyright
© 2020 Elsevier Inc.
