Axsain (Capsaicin / Lidocaine Hydrochloride) - Summary

AXSAIN SUMMARY

Axsain contains capsaicin USP, in a patented emollient base containing benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, lidocaine hydrochloride, PEG-100 stearate, purified water; sorbitol solution and white petrolatum.

Axsain is indicated for the temporary relief of neuralgia pain, including painful diabetic neuropathy (PDN) and postherpetic neuralgia (PHN), when used under the supervision of a physician. Axsain is particularly useful as adjunctive therapy for PDN and PHN patients experiencing incomplete pain relief despite taking oral antiepileptics or tricyclic antidepressants.

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NEWS HIGHLIGHTS

Published Studies Related to Axsain (Capsaicin / Lidocaine)

Capsaicin 8% patch for treprostinil subcutaneous infusion site pain in pulmonary hypertension patients. [2014]
trepostinil-induced pain... CONCLUSIONS: Further investigation of the efficacy of capsaicin 8% patch in this

Inhibition of capsaicin-driven nasal hyper-reactivity by SB-705498, a TRPV1 antagonist. [2014]
pharmacodynamics (PD) of intranasal SB-705498, a selective TRPV1 antagonist... CONCLUSIONS: Intranasal SB-705498 has an appropriate safety and PK profile for

Diclofenac with or without an antiemetic for acute migraine headaches in adults. [2013]
CONCLUSIONS: Oral diclofenac potassium 50 mg is an effective treatment

Topical capsaicin (low concentration) for chronic neuropathic pain in adults. [2012]
CONCLUSIONS: There were insufficient data to draw any conclusions about

Capsaicin instillation for postoperative pain following total knee arthroplasty: a preliminary report of a randomized, double-blind, parallel-group, placebo-controlled, multicentre trial. [2011.12.01]
BACKGROUND: Pain following total knee arthroplasty (TKA) interferes with rehabilitation. Capsaicin applied in high concentration to nociceptors can cause relatively selective C-fibre desensitization for a period of weeks to months. Resultant long-lasting analgesia might facilitate rehabilitation. OBJECTIVE: The objective of this study was to determine if direct instillation of a high-concentration capsaicin preparation into the wound following TKA would provide pain relief, improve physical functioning and rehabilitation, and reduce opioid requirements... CONCLUSION: Despite having higher BMIs, patients in the capsaicin group achieved comparable or better pain scores with significantly less opioid use in the first 3 postoperative days. They also had less pruritus, which may have been a consequence of the opioid-sparing effect. The effects of capsaicin with respect to function, however, appeared to be longer lasting, with improved active ROM reported at 14 days.

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Clinical Trials Related to Axsain (Capsaicin / Lidocaine)

The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain [Recruiting]
Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial hypertension, a life threatening disease of the lung blood vessels. Unfortunately, treprostinil is irritating to the skin and many patients experience intense pain at the infusion site for the first 7-10 days after placing a new subcutaneous infusion site. Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that pretreatment of an area of skin with Qutenza would decrease the pain associated with a new treprostinil infusion site. The investigators hope that Qutenza will decrease both the intensity of the pain and the duration of the pain after patients place a new treprostinil infusion site. In this initial study, the investigators will provide Qutenza in open-label, unblinded fashion and ask patients to rate their pain using a diary tool with which they are already comfortable.

Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain [Not yet recruiting]
A prospective study to determine the effectiveness and longevity of 8% capsaicin patch in treating neuropathic pain in persons with spinal cord injury. The investigators will study spinal cord injury patients at South Texas Veterans Health Care Systems Spinal Cord Injury inpatient unit and outpatient clinics.

The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability [Completed]
An altered permeability has been proposed to play an important role in the pathogenesis of several gastrointestinal disorders, such as irritable bowel syndrome and inflammatory bowel disease. Nutrients derived from food are able to influence the permeability of the intestine and can therefore also affect gastrointestinal symptoms. In this study, the investigators will investigate the effects of capsaicine and cinnamaldehyde, which can be found in hot peppers and cinnamon, respectively, on gastrointestinal physiology. Objective: To obtain more information about the effects of capsaicin and cinnamaldehyde on the intestine, these substances will be infused directly in the duodenum. Hereafter, the permeability of the intestine, gallbladder motility and the effects on satiety will be assessed. Hypothesis: Duodenal capsaicin and cinnamaldehyde infusion induces changes in the intestinal epithelial barrier function by selectively acting on TRPV1 and TRPA1 receptors and releasing serotonin from enterochromaffin cells as determined by the multi sugar permeability test

A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN) [Completed]

Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis [Recruiting]
The proposed study seeks to investigate the effect of intranasal capsaicin treatment in patient with Non-allergic irritant rhinitis (NAIR), as well as evaluate optical rhinometry (ORM) as a means to quantify symptomatic improvement in NAIR patients during and after treatment.

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