Intrathecal pain management with ziconotide: Time for consensus?

Abstract

This article summarizes recommendations made by six pain specialists who discussed the rationale for ziconotide intrathecal analgesia (ITA) and the requirement for evidence‐based guidance on its use, from a European perspective. Riemser Pharma GmbH (Greifswald, Germany), which holds the European marketing authorization for ziconotide, hosted the meeting. The group agreed that ITA is under‐used in Europe, adding that ziconotide ITA has potential to be a first‐line alternative to morphine; both are already first‐line options in the USA. Ziconotide ITA (initiated using a low‐dose, slow‐titration approach) is suitable for many patients with noncancer‐ or cancer‐related chronic refractory pain and no history of psychosis. Adopting ziconotide as first‐line ITA could reduce opioid usage in these patient populations. The group advocated a risk‐reduction strategy for all candidate patients, including compulsory prescreening for neuropsychosis, and requested US–European alignment of the licensed starting dose for ziconotide: the low‐and‐slow approach practiced in the USA has a better tolerability profile than the fixed high starting dose licensed in Europe. Of note, an update to the European Summary of Product Characteristics is anticipated in early 2021. The group acknowledged that the Polyanalgesic Consensus Conference (PACC) treatment algorithms for ziconotide ITA provide useful guidance, but recommendations tailored specifically for European settings are required. Before a consensus process can formally begin, the group called for additional European prospective studies to investigate ziconotide in low‐and‐slow dosing strategies, in different patient settings. Such data would enable European guidance to have the most appropriate evidence at its core.

Marine Natural Products in Clinical Use

“…Therefore, experts believe that the psychological state of patients must be assessed a priori before treatment with ziconotide [ 190 ]. Ziconotide has been in clinical use for more than a decade and holds precedence for cancer-related and some noncancer-related pain management because of its high benefit-to-risk ratio compared to other opioid drugs, even today [ 191 , 192 ]. Experts also propose that this class of diverse peptide drugs may contribute to the list of therapeutic medicines for various diseases in the future because of its selectivity toward receptors, ion channels, and enzymes [ 184 ].…”

Interventional Pain Procedures: A Narrative Review Focusing On Safety and Complications. PART 2 Interventional Procedures For Back Pain

“…Side effects include Baclofen withdrawal symptoms (including pruritus, sweating, neurogenic pulmonary edema, anxiety, hyperthermia, seizures, myoclonus, rhabdomyolysis, disseminated intravascular coagulations, multisystem organ failure, cardiac arrest, coma, and death), depression, suicidality, cognitive impairment, decreased levels of consciousness, and raised creatine kinase levels. [77][78][79] Implantation of these devices relatively rarely leads to serious complications; however, particularly in cancer patients suffering from an immunocompromised state, a potentially devastating complication is infection due to their immunocompromised states. The most frequent post-operative infection related to these devices is a surgical site infection (SSI).…”

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“…Therapeutic Potential of Ca 2+ Channel Blockers N-type Ca v 2 channels have been recognized as targets for antiallodynic drugs for many years. The limitations to the use of the channel blocker ziconotide and the α2-adrenoceptor ligand clonidine have already been alluded to (363). Although gabapentinoids interact indirectly with Ca v 2 via their α2δ-1 subunits they are neither universally effective or without undesirable adverse effects (96).…”

“…The main drawback is that it needs to be delivered directly to the spinal cord via an intrathecal drug delivery system. Zicononotide (Prialt) is usually only effective in patients with severe, intractable forms of chronic pain such as that associated with cancer ( 82 , 363 ).…”