Injected capsaicin for pain in Mortons neuroma

NewsBot · Mar 11, 2016

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A randomized, double blind, placebo controlled trial of injected capsaicin for pain in Mortons neuroma.
Campbell CM, Diamond E, Schmidt WK, Kelly M, Allen R, Houghton W, Brady KL, Campbell JN.
Pain. 2016 Mar 8

Intermetatarsal neuroma, or Morton's neuroma, is a painful foot condition resulting from an entrapment of the common digital nerve typically in the third intermetatarsal space. The pain can be severe and especially problematic with walking. Treatment options are limited and surgery may lead to permanent numbness in the toes. Capsaicin, the pungent ingredient of hot peppers, produces analgesia by inducing retraction of nociceptive afferents from the area of innervation and is effective in treating certain neuropathic pain disorders. A randomized double blind placebo controlled study was conducted to test the efficacy, tolerability, and safety of a single 0.1 mg dose of capsaicin versus placebo injected into the region of the neuroma. A total of 58 subjects diagnosed with Morton's Neuroma with foot pain ≥4 (0-10 numerical pain rating scale), were injected with 2 mL of lidocaine into the intermetatarsal space proximal to the neuroma to provide local anesthesia. Five minutes later, 0.1 mg capsaicin or placebo was injected into the intermetatarsal space containing the painful neuroma. Average foot pain was rated for two weeks before through four weeks following injection. At Weeks 1 and 4, the decrease in pain was significantly greater in the subjects treated with capsaicin (p=0.021 and p=0.019, respectively). A trend toward significance was noted at Weeks 2 and 3. Improvements in functional interference scores and reductions in oral analgesic use were also seen in the capsaicin treated group. These findings suggest that injected capsaicin is an efficacious treatment option for patients with painful intermetatarsal neuroma.
SUMMARY:
A single injection of capsaicin into the area around the neuroma resulted in a significant reduction in pain in Morton's neuroma patients
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NewsBot · Nov 4, 2016

Use of Capsaicin to Treat Pain: Mechanistic and Therapeutic Considerations.
Chung MK, Campbell JN
Pharmaceuticals (Basel). 2016 Nov 1;9(4). pii: E66.

Capsaicin is the pungent ingredient of chili peppers and is approved as a topical treatment of neuropathic pain. The analgesia lasts for several months after a single treatment. Capsaicin selectively activates TRPV1, a Ca2+-permeable cationic ion channel that is enriched in the terminals of certain nociceptors. Activation is followed by a prolonged decreased response to noxious stimuli. Interest also exists in the use of injectable capsaicin as a treatment for focal pain conditions, such as arthritis and other musculoskeletal conditions. Recently injection of capsaicin showed therapeutic efficacy in patients with Morton's neuroma, a painful foot condition associated with compression of one of the digital nerves. The relief of pain was associated with no change in tactile sensibility. Though injection evokes short term pain, the brief systemic exposure and potential to establish long term analgesia without other sensory changes creates an attractive clinical profile. Short-term and long-term effects arise from both functional and structural changes in nociceptive terminals. In this review, we discuss how local administration of capsaicin may induce ablation of nociceptive terminals and the clinical implications.
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NewsBot · Apr 4, 2017

CNTX-4975 (Trans-Capsaicin) Injection Provides Clinically Meaningful Pain Reduction in Subjects with Painful Intermetatarsal Neuroma (Morton’s Neuroma): A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study
R. Stevens, J. Campbell, I. Gottlieb, K. Guedes, R. Burges, M. Kelly, P. Hanson
Journal of Pain; April 2017Volume 18, Issue 4, Supplement, Page S70

Morton’s neuroma (MN) is a painful condition of the third intermetatarsal
space caused by distal common digital nerve compression.
CNTX-4975 is a highly purified, synthetic, trans-capsaicin that deactivates
TRPV1-expressing nociceptive afferents for months. Prior
trial data support the use of injectable CNTX-4975 to treat MN in
subjects who fail conservative measures.1 The primary efficacy
endpoint in this 12-week randomized, double-blind, placebocontrolled
trial was the change from baseline to week 4 in the
average diary scores for neuroma foot pain with walking using
the Numeric Pain Rating Scale. Clinically meaningful pain reduction
was defined as $30% pain reduction versus baseline. Safety and
tolerability assessments included treatment-emergent adverse
events (TEAEs) and sensory function examination. Subjects received
placebo (n=39), CNTX-4975 200 mg (n=38), or 600 mg (n=39) as a single
ultrasound-guided injection following ankle-block anesthesia.
Although the primary endpoint did not reach statistical significance,
both doses were numerically superior to placebo, with greater clinically
meaningful reductions from baseline at weeks 4 and 12. One
study site had a high placebo rate in a post-hoc analysis excluding
this site, results either achieved (weeks 5 and 12 p<0.05) or neared
statistical significance despite a 34% decrease in the number of subjects.
The cumulative responder analysis at week 12 showed >90%
pain reduction versus baseline for 2% of the placebo group and
40% of the CNTX-4975 200-mg group. In total, 63% of subjects reported
$1 TEAE (56%, placebo 74%, CNTX-4975 200 mg 56%,
CNTX-4975 600 mg). No decline was observed in tactile sensibility
following injection. A single injection of CNTX-4975 200 or 600 mg
for MN provided rapid and prolonged clinically meaningful pain
reduction with good tolerability. Funded by Centrexion Therapeutics.
(1. Campbell, et al., Pain, 2016)
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NewsBot · Feb 8, 2019

This patent was just granted:
Capsaicin sequential dosing method for treatment of morton's neuroma pain

A method of ameliorating pain for a duration of at least 3 months due to an intermetatarsal neuroma in a patient, comprising administering by injection into or adjacent to the patient's intermetatarsal space having an intermetatarsal neuroma at least a first dose of capsaicin and a second dose of capsaicin, no sooner than one month after the first dose, to ameliorate pain due to the intermetatarsal neuroma.
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Link to patent

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