Ziconotide official document review · version 1
This page preserves this version's findings, scope and source pins. Open the current profile →
Inside the official reviews
Reviewed 2026-09-19 · Preserved version 1
The evidence concerns severe pain requiring intrathecal treatment
EMA’s original Prialt discussion describes three placebo-controlled studies in severe chronic pain. Improvements were measured using pain-intensity scores, and the populations included malignant and non-malignant pain. EMA PDF pp. 33, 34 ↗
More findings, study links and document coverage
Short-term benefit did not establish long-term maintenance
The assessment found limited efficacy data beyond three weeks, particularly for malignant pain. Its positive assessment therefore included further observational follow-up; this historical document does not report the eventual outcome of that follow-up. EMA PDF pp. 33, 34 ↗
Neurological adverse effects were central
Confusion, memory impairment, dizziness and other neurological events were prominent. Later study conditions reduced some adverse effects, but EMA still described a narrow therapeutic window. EMA PDF pp. 31, 32, 33 ↗
Procedure and combination risks remain separate
The review discusses meningitis risk associated with intrathecal delivery and unresolved evidence for combinations with other intrathecal medicines. Results for this specialist route cannot establish benefit or safety for other preparations or routes. EMA PDF pp. 30, 33, 34 ↗
Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.
Document coverage
Selected sections read in 1 of 1 inventoried documents; 0 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.
One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading. EMA inventory source ↗
Inspect documents, application identities and source pins
Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.
Prialt : EPAR - Scientific Discussion ↗
Selected sections reviewed · ema-28994 · Document/feed date: 2006-08-31
The undated initial scientific discussion names the product. Application identity comes from the separately pinned EMA medicine record, and the date is the documents-feed first-publication date, not an adoption date.
Verified: Prialt · EMEA/H/C/000551 · EMA first-publication date 2006-08-31. Product identity checked on PDF pp. 1.
The undated PDF does not print the application number. The application is reconciled separately against EMA medicine record EMEA/H/C/000551 ↗, retrieved 2026-09-15. Its first-publication date is not an assessment-adoption date.
Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.
Retrieved 2026-09-19. Read PDF pages: 1, 30, 31, 32, 33, 34 of 35. SHA-256:
4617076b4f396aefe6db3b8a3b1e3545ac75a5f94b0162a797541d7b1f62a16e.Feed-listed application (not a verified association): EMEA/H/C/000551.
Remaining work
- Review later Prialt safety updates and long-term observational follow-up.
- Appraise original pain-trial reports by malignant versus non-malignant disease and prior intrathecal therapy.