Clinical Studies

Efficacy evaluation

  • 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

Safety evaluation

  • Evaluated in 1254 patients with severe chronic pain6
  • Mean duration of treatment was 193 days6

Total Patients Evaluated6

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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%).

Please see full Prescribing Information, including BOXED Warning, and click here for additional Important Safety Information.

References: 6. PRIALT [package insert]. Palo Alto, CA: Jazz Pharmaceuticals; February 2013. 11. Wallace MS, Charapata SG, Fisher R, et al; Ziconotide Nonmalignant Pain Study 96‐002 Group. Intrathecal ziconotide in the treatment of chronic nonmalignant pain: a randomized, double‐blind, placebo‐controlled clinical trial. Neuromodulation. 2006;9(2):75‐86. 12. Staats PS, Yearwood T, Charapata SG, et al. Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS: a randomized controlled trial. JAMA. 2004;291(1):63‐70. 13. Rauck RL, Wallace MS, Leong MS, et al; Ziconotide 301 Study Group. A randomized, double‐blind, placebo‐controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31(5):393‐406.
Patient Demographics
Efficacy Results
Discontinuation Rates
Adverse Events