Efficacy Results in Slow Titration Study
Slow Titration Study Design6,13
In a controlled trial using the slow-titration schedule in patients with severe chronic pain (n=112 PRIALT-treated patients, n=108 placebo), patients were weaned from IT analgesics and started on systemic analgesics, including oral opioids, over a 3-week period, followed by a 1-week stabilization period; 93% of patients successfully completed the weaning process and entered the study. PRIALT or placebo was administered IT for 3 weeks.6,13
Dosing with PRIALT was started at 2.4 mcg/day (0.1 mcg/hr) and the dose was increased by 2.4 mcg/day (0.1 mcg/hr) two to three times/week (minimum titration interval 24 hours) to a maximum dose of 19.2 mcg/day (0.8 mcg/hr) as needed for management of pain. The final mean dose at the end of the trial at 21 days was 6.9 mcg/day (0.29 mcg/hr). The primary efficacy measure was mean percent reduction in VASPI score from baseline to Day 21.6,13
At Week 3, PRIALT Reduced Pain From Baseline Significantly
More Than Placebo (ITT Population)6
The mean daily dose at Week 3 was 6.9 mcg/day.
Use of Weekly Systemic Opioids Declined at End of Week 3 When on PRIALT6
The most common adverse reactions (≥5% and more frequent with PRIALT than with placebo) were dizziness (46%), nausea (40%), asthenia (18%), diarrhea (18%), somnolence (17%), vomiting (16%), confusional state (15%), abnormal gait (14%), ataxia (14%), headache (13%), blurred vision (12%), urinary retention (9%), amnesia (8%), anxiety (8%), nystagmus (8%), dysarthria (7%), memory impairment (7%), rigors (7%), tremor (7%), vertigo (7%), anorexia (6%), muscle spasms (6%), pain in limb (5%), pyrexia (5%), and sinusitis (5%).6
Important Safety Information
Withdrawal From Opiates
PRIALT is not an opiate and cannot prevent or relieve the symptoms associated with the withdrawal of opiates. To avoid withdrawal syndrome when opiate withdrawal is necessary, do not abruptly reduce or withdraw opioid medications. For patients being withdrawn from IT opiates or IT opiate infusion, gradually taper over a few weeks and replace with a pharmacologically equivalent dose of oral opiates.
Please see full Prescribing Information, including BOXED Warning, and click here for additional Important Safety Information.