PRIALT (ziconotide) solution, intrathecal infusion: US FDA label indications
US FDA labelNot medical advice
The product name above is taken from the label's own indications text; the source record has no brand or generic name field.
Indications and usage (label excerpt)
1 INDICATIONS AND USAGE PRIALT (ziconotide) solution, intrathecal infusion is indicated 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, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. PRIALT (ziconotide) solution, intrathecal infusion is an N-type calcium channel antagonist indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. ( 1 )
Warnings (label excerpt)
5 WARNINGS AND PRECAUTIONS Cognitive and neuropsychiatric adverse reactions, Cognitive impairment and severe neuropsychiatric symptoms may occur with PRIALT use. ( 5.1 ) Meningitis and other infections, Patients, caregivers, and healthcare providers must be aware of the signs and symptoms of meningitis, including but not limited to fever, headache, stiff neck, altered mental status (e.g., lethargy, confusion, disorientation), nausea or vomiting, and occasionally seizures. ( 5.2 ) Reduced level of consciousness, Patients may become unresponsive or stuporous while receiving PRIALT. ( 5.3 ) Elevation of serum creatine kinase, Patients taking PRIALT may experience elevations in creatine kinase. Monitor serum CK in patients undergoing treatment with PRIALT periodically. ( 5.4 ) Withdrawal from opiates : Patients must not be abruptly withdrawn from opiates and must be gradually tapered over a few weeks and replaced with a pharmacologically equivalent dose of oral opiates. ( 5.5 ) 5.1 Cog…
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Trials whose interventions mention this drug
Canadian trials first. A match on the drug name does not mean the trial studied this specific product.
2 trials, recruiting first
| Phase | Countries | ||||
|---|---|---|---|---|---|
| Ziconotide for Non-cancer Pain by Intrathecal Administration NCT06541184 | Recruiting | France | ESTEVE Pharmaceuticals SAS | 2024-10-30 | |
| Prialt (Ziconotide) In Severe Chronic Pain NCT00047749 | Completed | Phase 3 | United States | Elan Pharmaceuticals | 2002-08 |
Source: openFDA drug label (US FDA), snapshot October 2026. Not a Health Canada Product Monograph.