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)
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.
A randomized, double-blind, parallel trial comparing capsaicin nasal spray with placebo in subjects with a significant component of nonallergic rhinitis. [2011.08]
OBJECTIVE: To investigate the efficacy and safety of ICX72 or Sinus Buster, a proprietary homeopathic preparation of Capsicum annum and Eucalyptol, versus placebo administered continuously over 2 weeks in subjects with a significant component of nonallergic rhinitis (NAR)... CONCLUSION: This is the first controlled trial demonstrating intranasal capsaicin, when used continuously over 2 weeks, rapidly and safely improves symptoms in rhinitis subjects with a significant NAR component. Copyright (c) 2011 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
Self-reported sleep duration associated with distraction analgesia, hyperemia, and secondary hyperalgesia in the heat-capsaicin nociceptive model. [2011.07]
Although sleep deprivation is known to heighten pain sensitivity, the mechanisms by which sleep modifies nociception are largely unknown. Few studies of sleep-pain interactions have utilized quantitative sensory testing models that implicate specific underlying physiologic mechanisms...
Effects of lidocaine patch on intradermal capsaicin-induced pain: a double-blind, controlled trial. [2011.03]
This study evaluated the effects of topical lidocaine on skin sensation and on intradermal capsaicin-induced pain and hyperalgesia. A randomized, double-blinded, placebo controlled methodology was used...
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.
Acute Response Capsaicin Flare Study [Recruiting]
Prior to administering PF-04427429 to patients we wish to increase the understanding of
functional effects associated with calcitonin gene related peptide (CGRP) pathways. This
study will examine whether it is possible for a single dose of PF-04427429 to acutely
attenuate a capsaicin induced flare response.
Pre-emptive Analgesia With Qutenza in Lower Limb Amputation [Not yet recruiting]
Neuropathic (nerve pain) following amputation of a limb is very common, affecting 60-80% of
patients (Sherman et al, 1984). It can prolong their recovery making it difficult to fit
protheses and mobilise. Current treatment options are limited and existing painkillers have
significant side effects. Nevertheless there is some evidence that pre-emptive analgesia
(pain relief provided prior to the surgery) has additional benefits after the surgery
(Ypsilantis & Tang, 2010) Qutenza (topical capsaicin 8%)is a novel analgesic agent which is
applied directly onto the skin. It works by desensitising to pain receptors in the skin
(Nolano et al., 1999) and has been shown to be effective in reducing neuropathic pain in
other conditions (Backonja et al., 2008) We propose to evaluate the use of Qutenza for
pre-emptive analgesia in patients undergoing amputation of a limb. This is a small, pilot,
randomised controlled study of 30 patients undergoing lower limb amputation who will have
Qutenza or active control applied prior to surgery. They will be followed up for 12 weeks
post-operatively with regular assessment of pain scores, quality of life and wound healing.
Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch [Recruiting]
The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic
is applied prior to the application of QUTENZA. This is a multi-center, randomized,
assessor-blinded study which will investigate the use of an oral analgesic as an alternative
form of pre-treatment for QUTENZA.
Qutenza for Critical Ischaemia in End Stage Renal Failure [Not yet recruiting]
Critical ischaemia is pain at rest as the result of poor blood flow and lack of oxygen being
delivered to the tissues. It normally affects the hands and feet and can be very
debilitating. It is particularly common and difficult to treat in patients with end stage
renal failure
Patients with renal failure are often high risk of any operative intervention which might
help the pain. Often the only treatment options are painkillers. Unfortunately however, the
commonly used painkillers, for example morphine, are known to cause worse side effects in
patients with renal failure (drowsiness, confusion etc.
Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied
to the skin as a patch and works directly at the nerve endings in the skin to prevent pain.
It therefore should not have the systemic side effects of other drugs. It has been
demonstrated to be beneficial in other painful conditions for example post-shingles pain and
nerve pain from HIV. It has never been used for critical ischaemia before.
We propose to investigate the efficacy of Qutenza in treating patients with end stage renal
failure and painful ischaemia. We will recruit 20 patients with painful ischaemia and treat
them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain
scores.
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