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Biotech / Medical : Neurex Corporation
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To: Dr. John M. de Castro who wrote (389)1/14/1998 10:06:00 AM
From: NeuroInvestment  Read Replies (1) of 449
 
Three notes:
1) Technically, ziconotide is a specific calcium channel blocker, operating at a slightly different location than competitive NMDA antagonists. The neuropsychiatric side effects sometimes seen in the latter class of drugs (hallucinations, catatonia) have not to my knowledge been associated with ziconotide.The side effects of the two classes can be quite different, for example the late and lamented NMDA antagonist Cerestat caused mild hypertension.
2) The hypotensive crises have been associated with IV use of ziconotide in head trauma, where the dose is several thousandfold greater (70mg per day) as opposed to the .3-300 micrograms qd used intrathecally in pain. It is true that blood brain barrier absorption cuts down greatly on the amount of drug actually reaching the brain in IV administration, thus the ultimate difference in brain levels reached is much less (and perhaps those patients reporting dizziness are having some mild hypotension). However the hypotension issue will be irrelevant to malignant pain, and I do not expect it to be critical for ambulatory neuropathic pain patients, though there it will likely have to be monitored.
3) With ample headroom in sample size, and a reasonably robust treatment effect, analyzing the overall population of 'intent to treat' patients is not likely to significantly shake the efficacy findings. This is not a borderline level of magnitude where 30-40 patients would be expected to make a crucial difference. NeuroInvestment
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