ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2225

Cntx-4975 (Trans-Capsaicin) Injection Provides Clinically Meaningful Pain Reduction in Subjects with Painful Intermetatarsal Neuroma (Morton’s Neuroma): An Open-Label, Ascending-Dose Study

Peter Hanson1, Ira Gottlieb2, Margaret Kelly3, James Campbell1, Robert Allen4 and Randall Stevens1, 1Centrexion Therapeutics, Boston, MA, 2Chesapeake Research Group, Pasadena, MD, 3Edirutop, Christiansburg, VA, 4Allen Medical LLC, Malvern, PA

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords:

Session Information

Date: Tuesday, November 7, 2017

Title: Pain – Basic and Clinical Aspects Poster

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Morton’s neuroma (MN) is a painful condition of the third intermetatarsal space caused by distal common digital nerve compression. CNTX-4975, a highly purified, synthetic trans-capsaicin, targets the transient receptor potential vanilloid 1, producing analgesia via reversible desensitization of end terminals of primary afferent pain fibers. A prior double-blind randomized trial demonstrated efficacy of CNTX-4975 100 µg injected into the area surrounding the neuroma.* This phase 1b, open-label trial further evaluated dosing, safety (including sensory and motor examination), tolerability, efficacy, and duration of pain relief following injection of CNTX-4975.

Methods: Subjects with painful MN indicated their level of pain at baseline and up to 6 months following a single injection of CNTX-4975 200 µg or 600 µg using the Numeric Pain Rating Scale (NPRS; 0 [none]–10 [severe]). Clinically meaningful pain reduction was defined as ≥30% pain decrease versus baseline.

Results: Eleven subjects were enrolled (200 µg, n=5; 600 µg, n=6). The mean (SD) baseline pain score with walking was 5.7 (1.3). A substantial reduction in pain with walking was evident as early as 1 week in both dose groups (−3.0, 200 µg; −2.9, 600 µg). The mean (SD) change in pain with walking score at 8 weeks was −3.0 (3.8) in the 200-µg group and −4.3 (2.4) in the 600-µg group. At 6 months (only the 600-µg group was followed), the change in pain score was −3.8 (3.1). None of the subjects had a decrease in sensory or motor function compared with baseline. All 11 subjects reported procedure pain as tolerable.

Conclusion: A single injection of CNTX-4975 200 µg and 600 µg for MN provided a rapid and prolonged duration of clinically meaningful pain reduction with acceptable tolerability and safety. This study provides a basis for further randomized trials at these dose levels. *Campbell, et al, Pain, 2016.

Disclosure: P. Hanson, Centrexion Therapeutics, 3; I. Gottlieb, None; M. Kelly, None; J. Campbell, Centrexion Therapeutics, 3; R. Allen, None; R. Stevens, Centrexion Therapeutics, 3.

To cite this abstract in AMA style:

Hanson P, Gottlieb I, Kelly M, Campbell J, Allen R, Stevens R. Cntx-4975 (Trans-Capsaicin) Injection Provides Clinically Meaningful Pain Reduction in Subjects with Painful Intermetatarsal Neuroma (Morton’s Neuroma): An Open-Label, Ascending-Dose Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/cntx-4975-trans-capsaicin-injection-provides-clinically-meaningful-pain-reduction-in-subjects-with-painful-intermetatarsal-neuroma-mortons-neuroma-an-open-label-ascending-dose-study/. Accessed .

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/cntx-4975-trans-capsaicin-injection-provides-clinically-meaningful-pain-reduction-in-subjects-with-painful-intermetatarsal-neuroma-mortons-neuroma-an-open-label-ascending-dose-study/