Ziconotide

Ziconotide (Prialt) — ω-Conotoxin MVIIA / N-Type Calcium Channel Blocker

Evidence & Status

  • FDA Approved
  • Strong Human Evidence
  • Strong

At a Glance

An FDA-approved intrathecal-only ziconotide product for severe chronic pain when other treatment is inadequate or not tolerated. Current PRIALT dosing starts at no more than 2.4 mcg/day and has a recommended maximum of 19.2 mcg/day.

Plain English

Ziconotide is a highly specialized pain medicine delivered into the spinal fluid through an intrathecal system. It is not an IV, injectable-under-the-skin, oral, or general systemic peptide. PRIALT requires slow dose changes and close monitoring because serious neuropsychiatric and neurologic reactions can occur.

Overview

Ziconotide is a synthetic 25-amino-acid equivalent of omega-conotoxin MVIIA. PRIALT is an intrathecal-only non-opioid analgesic for severe chronic pain in adults for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment. It blocks N-type voltage-sensitive calcium channels; IV, SC, IM, oral, epidural, and generic systemic peptide use are outside this product boundary.

Research Summary

A randomized, double-blind, placebo-controlled human study supports slow-titration intrathecal ziconotide in adults with severe chronic pain. Current PRIALT labeling requires initiation at no more than 2.4 mcg/day, titration no more frequently than 2–3 times per week, and a recommended maximum of 19.2 mcg/day. Severe neuropsychiatric reactions, psychosis contraindication, cognitive and consciousness changes, infection/meningitis, and creatine-kinase monitoring remain label-specific safety boundaries.

Research Areas

  • Chronic neuropathic pain
  • Cancer pain
  • CRPS
  • Spinal cord injury pain
  • N-type calcium channel pharmacology
  • Conotoxin pharmacology

Safety & Risks

Serious Risks

  • PRIALT carries an FDA boxed warning for severe neuropsychiatric adverse reactions; severe psychiatric symptoms and neurological impairment can occur
  • PRIALT is contraindicated in patients with a pre-existing history of psychosis
  • Cognitive impairment, hallucinations, mood changes, reduced alertness, unresponsiveness, and suicidal ideation or behavior have been reported
  • Meningitis and other serious infections can occur in association with intrathecal microinfusion systems, particularly when sterility is compromised
  • Elevations in serum creatine kinase can occur; symptomatic myopathy and rare rhabdomyolysis-associated acute renal failure have been reported
  • Combination of PRIALT with intrathecal opioids is not recommended

Reported Side Effects

  • Dizziness
  • Nausea
  • Confusional state
  • Nystagmus
  • Vertigo
  • Blurred vision
  • Somnolence
  • Abnormal gait
  • Asthenia
United States
FDA-approved as PRIALT for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment. PRIALT is a prescription drug and is not federally scheduled by the DEA.
United Kingdom
International regulatory status is not represented by the selected sources in this record.
Australia
International regulatory status is not represented by the selected sources in this record.
Canada
International regulatory status is not represented by the selected sources in this record.

Citations & Sources