American Academy of Pain Medicine: Adjunctive Intrathecal Ziconotide: An Alternative Approach to Chronic Pain

7 Apr
2010

Adjunctive Intrathecal Ziconotide: An Alternative Approach to Chronic Pain

Speaker: Alexander A. Krakovsky, MD, PhD, DrSc, Pain Management Specialist, Interventional Pain Management, Galileo Medical Center, San Luis Obispo, California

Adjunctive intrathecal therapy with ziconotide (Prialt, Elan) represents the first of a new class of non-opioid analgesics called N-type calcium-channel blockers. This novel approach is used to treat a variety of debilitating chronic pain conditions.

To assess the value of this neuroprotective analgesic, investigators evaluated 17 patients with intrathecal delivery systems in place. The patients were enrolled in the study because pain control had been inadequate, dosages were excessive according to the Polyanalgesic Consensus Trial, and adverse drug effects (ADEs) limited therapeutic results.

In this selected group of patients, 70% reported significant efficacy with ziconotide adjunctive intrathecal therapy. Overall, 14 patients (82.3% of the total study group) reported a 10% to 15% decrease in pain scores. Nine patients (53%) increased their general activity level. Two patients (11.8%) were able to decrease their dose of intrathecal opioids, and three patients (17.6%) were able to decrease their adjunctive intrathecal therapy with bupivacaine (Sensorcaine, AstraZeneca) and clonidine (Catapres, Boehringer Ingelheim). Two patients (11.8%) reported a decrease in oral opioid therapy, and three patients (17.6%) were able to stop using ziconotide. Five patients (29.4%) had only limited use of the drug because of possible adverse events that might have been caused by the drug therapy.
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Intranasal Morphine Relieves Postsurgical Pain

Speaker: David B. Carr, MD, Chief Executive Officer and Chief Medical Officer, Javelin Pharmaceuticals, Cambridge, Massachusetts

Intranasal morphine (Rylomine, Javelin) provided a non-invasive, dose-dependent alternative to injectable morphine for the relief of moderate-to-severe postoperative pain in a randomized, double-blind, single-dose and multiple-dose, actively controlled and placebo-controlled study.

A total of 187 patients with post-orthopedic surgical pain were selected to receive intranasal morphine 3.75 mg (24 patients), 7.5 mg (24 patients), 15 mg (24 patients), or 30 mg (23 patients), intravenous (IV) morphine 7.5 mg (46 patients), or placebo (46 patients) in a single-dose phase and either intranasal morphine 7.5 mg (90 patients) or 15 mg (87 patients) for the rest of the study period. canadian pharmacy

The primary endpoint was a dose-response relationship, determined by VAS scores for total pain relief over four hours. Secondary endpoints included (1) categorical total pain relief over four hours; (2) total pain relief over four hours, both VAS and categorized, over other time intervals up to 24 hours; (3) pain intensity; (4) pain relief; (5) the patient global evaluation; and (6) assessment of the frequency, number, and time elapsed until rescue medication following intranasal morphine 7.5 and 15 mg in the multiple-dose phase. Safety assessments included ADEs and a nasal examination.

Intranasal morphine 15 or 30 mg or IV morphine, as measured by total pain relief over four hours, provided statistically superior dose-dependent pain relief compared with placebo (P < .0001). Step-down testing demonstrated that the minimum effective dose of intranasal morphine was 7.5 mg. The multiple-dose phase of the study showed that dosing intervals of one to two hours for morphine 7.5 mg and two to three hours for morphine 15 mg relieved pain.

Overall, local nasal morphine-related ADEs were transient and mostly mild, including a bad taste, nasal congestion, throat irritation, and sneezing. Systemic ADEs, regardless of the route of administration, were dose-related and were consistent with common ADEs associated with opioids.

 

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