Pain · FDA Approved
Ziconotide (Prialt)
FDA-approved
01 · Overview
A synthetic 25-amino acid peptide identical to omega-conotoxin MVIIA from the venom of the marine cone snail Conus magus. Ziconotide potently and selectively blocks N-type voltage-gated calcium channels, and its analgesic effect is thought to come from interrupting pain signaling in the spinal cord (PMID 19300539).
It is not an opioid, and prolonged use has not been associated with addiction or tolerance (PMID 19300539).
02 · Research summary & key findings
FDA-approved in 2004 (Prialt) for severe chronic pain in patients needing intrathecal therapy who are intolerant of or refractory to other treatments, including intrathecal morphine (PMID 16703976). It is the only non-opioid intrathecal analgesic approved by the FDA and must be given by intrathecal infusion (PMID 23999971). Randomized placebo-controlled trials in cancer, AIDS and non-cancer pain showed greater pain reduction than placebo (PMID 23999971). CNS side effects such as dizziness, confusion, ataxia and memory impairment are the main tolerability concern, psychiatric symptoms have been reported, and slow titration improves tolerability (PMID 16716870) (PMID 16703976).
03 · Regulatory status
Ziconotide (Prialt) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Ziconotide (Prialt) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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Ziconotide (Prialt) is prescribed for the conditions on its label, and it is not part of our intake. If you are working on injury recovery and tissue repair, a licensed clinician can tell you at a free consultation whether an FDA-approved or lawfully compounded treatment fits you, or whether nothing does.
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04 · Administration routes
- Intrathecal infusion
References
- [1]Treatment challenges and complications with ziconotide monotherapy in established pump patients Pain Physician, 2006. PMID 16703976
- [2]A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain J Pain Symptom Manage, 2006. PMID 16716870
- [3]Ziconotide: a review of its pharmacology and use in the treatment of pain Neuropsychiatr Dis Treat, 2007. PMID 19300539
- [4]Intrathecal ziconotide: a review of its use in patients with chronic pain refractory to other systemic or intrathecal analgesics CNS Drugs, 2013. PMID 23999971
Primary literature
- PubMed: "Ziconotide"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Ziconotide"
Registered interventional and observational studies, including status and phase.
- PubChem: "Ziconotide"
Chemical structure, molecular properties, and bioactivity data.
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