The open-label study assessed the long-term safety and effectiveness
and outcomes of Hysingla ER (20, 40, 60, 80, 120 mg/day) treatment in
opioid-naïve and opioid-experienced patients aged 18 and over with
chronic pain severe enough to require around-the-clock opioid therapy.
This analysis assessed a subpopulation of patients aged 75 years and
older. After completing a 45-day dose titration period, a total of 20
elderly patients entered the 12-month maintenance period. The mean
“average pain over the last 24 hours” score decreased from 6.1 at
baseline to 3.9 by the end of a 45-day dose titration period, and the
reduction in mean pain score was maintained throughout the 12-month
treatment period with a final mean pain score of 3.6 at 52 weeks.
Purdue Pharma Presented post hoc analysis Results of Hysingla® ER
Purdue Pharma L.P. today presented results from a post hoc analysis
in 24 patients 75 and older from an open-label, long-term (12-month)
safety and effectiveness study of Hysingla® ER (hydrocodone bitartrate) at the 9th Annual PAINWeek®
Conference in Las Vegas, Sept. 8-12. Hysingla ER is a once-daily,
single-entity hydrocodone bitartrate tablet with abuse-deterrent
properties for the management of pain severe enough to require daily,
around-the-clock, long-term opioid treatment for which other treatment
options are inadequate.
The mean daily Hysingla ER dose increased during the titration period
from 24.2 mg at the beginning of the titration period to 40.8 mg at the
end of the dose titration period, and remained relatively stable during
the maintenance period with a mean daily dose at 12 months of 49.6 mg.
The use of nonstudy opioid drugs decreased during the dose titration
period from 7.9 mg at the beginning of the dose titration period to 1.9
at the end of the dose titration period and remained low throughout the
maintenance period, with patients taking no nonstudy opioid drugs by the
end of the study.
