Brain & sleep N-type Ca-channel blocker (conotoxin)
Ziconotide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Ziconotide (sold as Prialt) is a synthetic copy of a cone snail venom peptide, used as a non-opioid painkiller delivered directly into the spinal fluid for severe, treatment-resistant chronic pain. It blocks a specific calcium channel on pain-signaling nerves in the spinal cord. It has been FDA-approved in the U.S. since 2004, is given only by intrathecal pump, and carries a boxed warning for serious psychiatric and neurological effects.
At a glance
- What it is
- A synthetic cone snail peptide that blocks N-type calcium channels (a non-opioid analgesic)
- Approved for
- Severe chronic pain in patients who need intrathecal therapy and cannot use or have not responded to other treatments
- Key fact
- In a controlled trial it reduced pain scores substantially more than placebo in refractory pain
- Route
- Intrathecal infusion via an implanted or external pump
- Evidence strength
- FDA approved
Summary
Ziconotide (Prialt) is an FDA-approved non-opioid peptide for severe chronic pain, given by spinal pump. Learn how it works and its boxed warning.
What is ziconotide?
Ziconotide, sold under the brand Prialt, is a synthetic version of a peptide found in the venom of a marine cone snail, Conus magus. It is a potent non-opioid painkiller used for severe chronic pain, delivered directly into the cerebrospinal fluid around the spinal cord. It was developed under the code SNX-111 (its natural counterpart is omega-conotoxin MVIIA) and approved in the United States in 2004.
How does ziconotide work?
Ziconotide selectively blocks N-type voltage-gated calcium channels found on the pain-sensing nerves that terminate in the dorsal horn of the spinal cord. Those channels control the release of neurotransmitters that pass pain signals up to the brain. By blocking them, ziconotide prevents the release of these pain-signaling chemicals, interrupting transmission of the pain message at the level of the spinal cord.
Because it is a peptide that does not cross readily into the brain from the bloodstream, it has to be infused directly into the spinal fluid through a pump, and it must never be given intravenously. Its mechanism is entirely different from opioids, so it does not cause respiratory depression or the same tolerance, which is part of its appeal for intractable pain. In a controlled trial in refractory cancer and AIDS pain, ziconotide reduced pain scores substantially more than placebo. It has a narrow therapeutic window, so dosing is cautious and slow.
Is it FDA-approved?
Editor’s note
Status: Yes. Ziconotide (Prialt) was approved by the FDA in 2004 for the management of severe chronic pain in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatments. It carries a boxed warning for severe psychiatric symptoms and neurological impairment and is contraindicated in people with a history of psychosis.
Category: FDA-approved · Primary body area: Brain & sleep
Yes. Ziconotide (Prialt) was approved by the FDA in 2004 for the management of severe chronic pain in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatments. It carries a boxed warning for severe psychiatric symptoms and neurological impairment and is contraindicated in people with a history of psychosis.
What is ziconotide prescribed for?
Ziconotide is prescribed for severe chronic pain in carefully selected patients who need intrathecal (spinal) drug delivery and have not responded to or cannot tolerate other therapies, including intrathecal morphine. It is managed by pain specialists using an implanted or external microinfusion pump.
What are the side effects?
According to the prescribing information, common side effects include:
- Dizziness and nausea
- Confusion and memory problems
- Abnormal gait, drowsiness, and involuntary eye movements
More serious considerations include:
- A boxed warning for severe psychiatric symptoms (including depression and suicidal thoughts, hallucinations) and neurological impairment, so patients are monitored closely
- The need to stop the drug if serious neurological or psychiatric signs develop
- Meningitis or other infections if the pump or catheter becomes contaminated
Sources: FDA prescribing information for Prialt; a randomized trial of intrathecal ziconotide for refractory pain (Staats et al., JAMA, 2004, DOI: 10.1001/jama.291.1.63), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
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