- 3 double-blind, placebo-controlled, multicenter studies in a total of 457 patients (268 PRIALT, 189 placebo) were conducted (2 fast-titration studies and 1 slow-titration study)6
- Patients had mixed, neuropathic, and nociceptive pain types11-13
- Evaluated in 1254 patients with severe chronic pain6
- Mean duration of treatment was 193 days6
Total Patients Evaluated6
Important Safety Information
MOST COMMON ADVERSE REACTIONS
The most frequently reported adverse reactions (≥25%) in clinical trials (n=1254 PRIALT-treated patients) were dizziness, nausea, confusional state, and nystagmus. Slower titration of PRIALT may result in fewer serious adverse reactions and discontinuations for adverse reactions.
In a controlled trial using the slow-titration schedule in patients with severe chronic pain (n=112 PRIALT-treated patients, n=108 placebo), 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%).