Pharmacokinetic analysis of ziconotide (SNX-111), an intrathecal N-type calcium channel blocking analgesic, delivered by bolus and infusion in the dog

Neuromodulation

Volumn 15, Issue 6, 2012, Pages 508-519

  Yaksh, Tony L ^a   De Kater, Annelies ^b   Dean, Robin ^c   Best, Brookie M ^d,e   Miljanich, George P ^f  

^a University of California at San Diego   (United States)

^b Pain Therapeutics Inc   (United States)

^c Department of Research Services   (United States)

^d UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^e RADY CHILDREN'S HOSPITAL   (United States)

^f Airmid Incorporated   (United States)

Author keywords

Analgesia; antinociception; blood pressure; intrathecal; kinetics; SNX 111; spinal; ziconotide

Indexed keywords

DEXAMETHASONE SODIUM PHOSPHATE; INULIN; INULIN H 3; OMEGA CONOTOXIN MVIIA; UNCLASSIFIED DRUG;

AROUSAL; ARTICLE; ATAXIA; CATHETER; CEREBROSPINAL FLUID; DOG; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; MALE; NONHUMAN;

EID: 84870527944     PISSN: 10947159     EISSN: 15251403     Source Type: Journal    
DOI: 10.1111/j.1525-1403.2012.00479.x     Document Type: Article

References (50)

1. Olivera BM, Gray WR, Zeikus R, et al,. Peptide neurotoxins from fish-hunting cone snails. Science 1985; 230: 1338-1343. (Pubitemid 16105162)
2. Nadasdi L, Yamashiro D, Chung D, Tarczy-Hornoch K, Adriaenssens P, Ramachandran J,. Structure-activity analysis of a Conus peptide blocker of N-type neuronal calcium channels. Biochemistry 1995; 34: 8076-8081.
3. Cruz LJ, Olivera BM,. Calcium channel antagonists. Omega-conotoxin defines a new high affinity site. J Biol Chem 1986; 261: 6230-6233. (Pubitemid 17204126)
4. Reynolds IJ, Wagner JA, Snyder SH, Thayer SA, Olivera BM, Miller RJ,. Brain voltage-sensitive calcium channel subtypes differentiated by omega-conotoxin fraction GVIA. Proc Natl Acad Sci U S A 1986; 83: 8804-8807. (Pubitemid 17194954)
5. Miljanich GP,. Ziconotide: neuronal calcium channel blocker for treating severe chronic pain. Curr Med Chem 2004; 11: 3029-3040. (Pubitemid 39545572)
6. Takasusuki T, Yaksh TL,. Regulation of spinal substance P release by intrathecal calcium channel blockade. Anesthesiology 2011; 115: 153-164.
7. Chaplan SR, Pogrel JW, Yaksh TL,. Role of voltage-dependent calcium channel subtypes in experimental tactile allodynia. J Pharmacol Exp Ther 1994; 269: 1117-1123. (Pubitemid 24204194)
8. Malmberg AB, Yaksh TL,. Effect of continuous intrathecal infusion of omega-conopeptides, N-type calcium-channel blockers, on behavior and antinociception in the formalin and hot-plate tests in rats. Pain 1995; 60: 83-90.
9. Malmberg AB, Yaksh TL,. Voltage-sensitive calcium channels in spinal nociceptive processing: blockade of N- and P-type channels inhibits formalin-induced nociception. J Neurosci 1994; 14: 4882-4890. (Pubitemid 24237910)
10. Bowersox SS, Gadbois T, Singh T, Pettus M, Wang YX, Luther RR,. Selective N-type neuronal voltage-sensitive calcium channel blocker, SNX-111, produces spinal antinociception in rat models of acute, persistent and neuropathic pain. J Pharmacol Exp Ther 1996; 279: 1243-1249. (Pubitemid 27166771)
11. Gohil K, Bell JR, Ramachandran J, Miljanich GP,. Neuroanatomical distribution of receptors for a novel voltage-sensitive calcium-channel antagonist, SNX-230 (omega-conopeptide MVIIC). Brain Res 1994; 653: 258-266. (Pubitemid 24252847)
12. Yaksh TL,. Spinal systems and pain processing: development of novel analgesic drugs with mechanistically defined models. Trends Pharmacol Sci 1999; 20: 329-337. (Pubitemid 29366811)
13. Brose WG, Gutlove DP, Luther RR, Bowersox SS, McGuire D,. Use of intrathecal SNX-111, a novel, N-type, voltage-sensitive, calcium channel blocker, in the management of intractable brachial plexus avulsion pain. Clin J Pain 1997; 13: 256-259. (Pubitemid 27524086)
14. Atanassoff PG, Hartmannsgruber MW, Thrasher J, et al,. Ziconotide, a new N-type calcium channel blocker, administered intrathecally for acute postoperative pain. Reg Anesth Pain Med 2000; 25: 274-278. (Pubitemid 30337721)
15. Staats PS, Yearwood T, Charapata SG, et al,. Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS: a randomized controlled trial. JAMA 2004; 291: 63-70. (Pubitemid 38040536)
16. Wermeling D, Drass M, Ellis D, et al,. Pharmacokinetics and pharmacodynamics of intrathecal ziconotide in chronic pain patients. J Clin Pharmacol 2003; 43: 624-636. (Pubitemid 36613121)
17. Rauck RL, Wallace MS, Leong MS, et al,. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage 2006; 31: 393-406.
18. Rauck RL, Wallace MS, Burton AW, Kapural L, North JM,. Intrathecal ziconotide for neuropathic pain: a review. Pain Pract 2009; 9: 327-337.
19. Ridgeway B, Wallace M, Gerayli A,. Ziconotide for the treatment of severe spasticity after spinal cord injury. Pain 2000; 85: 287-289. (Pubitemid 30110771)
20. Penn RD, Paice JA,. Adverse effects associated with the intrathecal administration of ziconotide. Pain 2000; 85: 291-296. (Pubitemid 30110772)
21. Yaksh TL, Rathbun ML, Dragani JC, et al,. Kinetic and safety studies on intrathecally infused recombinant-methionyl human brain-derived neurotrophic factor in dogs. Fundam Appl Toxicol 1997; 38: 89-100.
22. Yaksh TL, Grafe MR, Malkmus S, Rathbun ML, Eisenach JC,. Studies on the safety of chronically administered intrathecal neostigmine methylsulfate in rats and dogs. Anesthesiology 1995; 82: 412-427.
23. Yaksh TL, Horais KA, Tozier NA, et al,. Chronically infused intrathecal morphine in dogs. Anesthesiology 2003; 99: 174-187. (Pubitemid 36799049)
24. Sabbe MB, Grafe MR, Mjanger E, Tiseo PJ, Hill HF, Yaksh TL,. Spinal delivery of sufentanil, alfentanil, and morphine in dogs. Physiologic and toxicologic investigations. Anesthesiology 1994; 81: 899-920. (Pubitemid 24332623)
25. Bowersox S, Mandema J, Tarczy-Hornoch K, Miljanich G, Luther RR,. Pharmacokinetics of SNX-111, a selective N-type calcium channel blocker, in rats and cynomolgus monkeys. Drug Metab Dispos 1997; 25: 379-383. (Pubitemid 27120586)
26. Yaksh TL, Malkmus SA,. Animal models of intrathecal and epidural drug delivery. In:, Yaksh TL, ed. Spinal drug delivery. Amsterdam: Elsevier Science B.V., 1999: 317-344.
27. Sabbe MB, Penning JP, Ozaki GT, Yaksh TL,. Spinal and systemic action of the alpha2 receptor agonist dexmedetomidine in dogs. Antinociception and carbon dioxide response. Anesthesiology 1994; 80: 1057-1072. (Pubitemid 24150887)
28. Yaksh TL, Rathbun M, Jage J, Mirzai T, Grafe M, Hiles RA,. Pharmacology and toxicology of chronically infused epidural clonidine HCl in dogs. Fundam Appl Toxicol 1994; 23: 319-335. (Pubitemid 24321716)
29. Yaksh TL, Horais KA, Tozier N, et al,. Intrathecal ketorolac in dogs and rats. Toxicol Sci 2004; 80: 322-334. (Pubitemid 39136387)
30. Nara E, Masegi M, Hatono T, Hashida M,. Pharmacokinetic analysis of drug absorption from muscle based on a physiological diffusion model: effect of molecular size on absorption. Pharm Res 1992; 9: 161-168.
31. Durant PA, Yaksh TL,. Distribution in cerebrospinal fluid, blood, and lymph of epidurally injected morphine and inulin in dogs. Anesth Analg 1986; 65: 583-592. (Pubitemid 16080702)
32. Bradbury MW, Westrop RJ,. Factors influencing exit of substances from cerebrospinal fluid into deep cervical lymph of the rabbit. J Physiol 1983; 339: 519-534. (Pubitemid 13104105)
33. Kizziar R, Nesbit GM,. The quantitative evaluation of cerebral spinal fluid flow. Semin Ultrasound CT MR 2000; 21: 452-461.
34. Loth F, Yardimci MA, Alperin N,. Hydrodynamic modeling of cerebrospinal fluid motion within the spinal cavity. J Biomech Eng 2001; 123: 71-79. (Pubitemid 32202582)
35. Bernards CM,. Understanding the physiology and pharmacology of epidural and intrathecal opioids. Best Pract Res Clin Anaesthesiol 2002; 16: 489-505. (Pubitemid 38937099)
36. Artru AA,. Spinal cerebrospinal fluid chemistry and physiology. In:, Yaksh TL, ed. Spinal drug delivery. Amsterdam: Elsevier Science B.V., 1999: 177-237.
37. Ummenhofer WC, Arends RH, Shen DD, Bernards CM,. Comparative spinal distribution and clearance kinetics of intrathecally administered morphine, fentanyl, alfentanil, and sufentanil [see comments]. Anesthesiology 2000; 92: 739-753. (Pubitemid 30130177)
38. Newcomb R, Abbruscato TJ, Singh T, Nadasdi L, Davis TP, Miljanich G,. Bioavailability of ziconotide in brain: influx from blood, stability, and diffusion. Peptides 2000; 21: 491-501. (Pubitemid 30261566)
39. Doucette R, Theriault E, Diamond J,. Regionally selective elimination of cutaneous thermal nociception in rats by neonatal capsaicin. J Comp Neurol 1987; 261: 583-591. (Pubitemid 17106424)
40. Valentino K, Newcomb R, Gadbois T, et al,. A selective N-type calcium channel antagonist protects against neuronal loss after global cerebral ischemia. Proc Natl Acad Sci U S A 1993; 90: 7894-7897. (Pubitemid 23250057)
41. Boehm S, Huck S,. Inhibition of N-type calcium channels: the only mechanism by which presynaptic alpha 2-autoreceptors control sympathetic transmitter release. Eur J Neurosci 1996; 8: 1924-1931. (Pubitemid 26302287)
42. Waterman SA,. Role of N-, P- and Q-type voltage-gated calcium channels in transmitter release from sympathetic neurones in the mouse isolated vas deferens. Br J Pharmacol 1997; 120: 393-398. (Pubitemid 27052836)
43. McGuire D, Bowersox S, Fellmann JD, Luther RR,. Sympatholysis after neuron-specific, N-type, voltage-sensitive calcium channel blockade: first demonstration of N-channel function in humans. J Cardiovasc Pharmacol 1997; 30: 400-403. (Pubitemid 28006857)
44. Wright CE, Robertson AD, Whorlow SL, Angus JA,. Cardiovascular and autonomic effects of omega-conotoxins MVIIA and CVID in conscious rabbits and isolated tissue assays. Br J Pharmacol 2000; 131: 1325-1336.
45. Bowersox SS, Singh T, Nadasdi L, Zukowska-Grojec Z, Valentino K, Hoffman BB,. Cardiovascular effects of omega-conopeptides in conscious rats: mechanisms of action. J Cardiovasc Pharmacol 1992; 20: 756-764.
46. Eisenach JC, Tong CY,. Site of hemodynamic effects of intrathecal alpha 2-adrenergic agonists [see comments]. Anesthesiology 1991; 74: 766-771.
47. Suzukawa M, Matsumoto M, Collins JG, Kitahata LM, Yuge O,. Dose-response suppression of noxiously evoked activity of WDR neurons by spinally administered fentanyl. Anesthesiology 1983; 58: 510-513. (Pubitemid 13107090)
48. Homma E, Collins JG, Kitahata LM, Matsumoto M, Kawahara M,. Suppression of noxiously evoked WDR dorsal horn neuronal activity by spinally administered morphine. Anesthesiology 1983; 58: 232-236. (Pubitemid 13164313)
49. Jain KK,. An evaluation of intrathecal ziconotide for the treatment of chronic pain. Expert Opin Investig Drugs 2000; 9: 2403-2410.
50. Smith HS, Deer TR,. Safety and efficacy of intrathecal ziconotide in the management of severe chronic pain. Ther Clin Risk Manag 2009; 5: 521-534.