Methods for treating pain

A botulinum toxin and neuron technology, applied in the field of pain treatment, can solve problems such as short duration of activity, ineffective clinical efficacy, and increased antigenicity

Inactive Publication Date: 2005-10-19
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Complications can arise due to the necessary surgical implantation step, and known intrathecal administration of drugs for the treatment of pain has the disadvantage of short duration of activity, allowing transport and / or diffusion through the intrathecal lumen and systemically to Lipid solubility in higher CNS regions, and possible respiratory depression consequences
The presence of an inactive botulinum toxin molecule in a clinical formulation contributes to the overall loading of the formulation, it has been linked to increased antigenicity and does not contribute to its clinical efficacy
Additionally, botulinum toxin type B is known to have a shorter duration of activity for intramuscular injection, being less potent than botulinum toxin type A at the same dose level

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] Analgesic Effect of Intrathecal Administration of Botulinum Toxin Type A on Inflammatory Pain

[0071] The purpose of this experiment was to study the analgesic effect of botulinum toxin type A on inflammatory pain using a rat formalin model.

[0072] Male Sprague-Dawley rats weighing 270 g to 350 g were each anesthetized with isoflurane. In this and all subsequent examples, a suture was performed by implanting an approximately 10 cm long PE (polyethylene)-10 tube through a supracisternal dural incision, threaded approximately 8.5 cm along the proximal caudal portion of the rat spinal cord to the vicinity of the lumbar enlargement. Intrathecal cannulation, performing intrathecal administration of neurotoxins, as described by Yaksh T. et al., Chronic Catheterization of the Spinal Subarachnoid Space, Physio & Behav 17: 1031-1036 (1976). BOTOX  Alternatively, control liquid saline was administered intrathecally from 0 to 5 hours prior to the formalin test via a lumbar...

Embodiment 2

[0078] Intrathecal administration of botulinum toxin type A provides analgesic effects for at least 14 days in inflammatory pain

[0079] Intrathecal cannulation of male Sprague-Dawley rats was performed as illustrated in Example 1 . Figure 2 (control, n=8) shows that BOTOX  (0.03ng / kg or 0.625U / kg, n=14) Rats pretreated 2 to 5 hours before formalin injection had reduced lifting / licking times in both phases 1 and 2. BOTOX  Analgesic effect in BOTOX  Treatment persisted for 7 days after treatment (0.625 U / kg, n=5), but decreased compared to 2 hours pretreatment (Figure 2). In addition, as shown in Figure 3, the analgesic effect seven days after intrathecal administration of botulinum type A was dose-dependent. Furthermore, as shown in Figure 4, BOTOX  The analgesic effect lasted at least 14 days (0.625u / KG, N=4). As shown in Figure 2, BOTOX was injected 0.5 hours before formalin stimulation  Pretreatment of rats failed to reduce formalin-induced pain.

[0080] This...

Embodiment 3

[0082] Comparison of the Analgesic Effects of Intrathecal Botulinum Toxin Type A and Muscimol on Inflammatory Pain

[0083] Intrathecal cannulation of the subject rats was performed as illustrated in Example 1. Intrathecal administration of BOTOX  (0.625U / kg, 2-5 hours or 6 days before the formalin test) or short-term analgesic muscimol (1 μg, 10 minutes or six days before the formalin test), and in the indicated The formalin test was performed at a later time.

[0084] As shown in Figure 5 (control saline, n=11), before the formalin test six days before BOTOX  The analgesic effect of the administration, compared with the analgesic effect of the intrathecal administration of muscimol six days before the formalin test, had a longer duration of analgesic activity through most of phase 2. In addition, Figure 5 shows that BOTOX  Intrathecal administration and muscimol intrathecal administration 10 minutes before formalin challenge produced comparable analgesia.

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Abstract

Methods for treating pain by intrathecal administration to a human patient of a therapeutically effective amount of a neurotoxin such as botulinum toxin type A are disclosed.

Description

[0001] This application is a divisional application of the patent application 00814257.2 of the international application PCT / US00 / 12597 entered into China. technical field [0002] The present invention relates to methods of treating pain. In particular, the invention relates to methods of treating pain by intraspinal administration of neurotoxins. Background technique [0003] Many, if not most, physical illnesses cause pain. Pain is generally felt when the free nerve endings that make up nociceptors in the skin and in an internal tissue are stimulated mechanically, thermally, or chemically. Pain receptors transmit signals along the afferent neurons to the central nervous system and from there to the brain. [0004] Causes of pain include inflammation, injury, disease, muscle spasms, and neuropathic events or syndromes. Incurable pain is detrimental to the patient by limiting function, reducing mobility, affecting sleep and greatly interfering with quality of life. [...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M31/00A61K38/00A61K38/48A61P25/04
CPCA61K38/00A61K38/4893A61P25/04A61P29/02Y02A50/30A61K39/08
Inventor K·R·奥基崔明磊
Owner ALLERGAN INC
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