Preliminary safety, tolerability and efficacy of ALGRX 4975 in Osteoarthritis (OA) of the knee

Cantillon, Marc; Vause, E.; Sykes, Daniel; Russell, Richard; Moon, A.; Hughes, Sophie

doi:10.1016/j.jpain.2005.01.152

Cited by 4 publications

(7 citation statements)

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“…The primary end-point was average daily VAS scores, assessed during movement upon arising in the morning and retiring in the evening, during the first week after surgery. Pain scores during the first week were chosen as a primary outcome based upon pilot studies [12][13][14][15] and the theoretical duration of c-fiber inhibition, 9 assuming high pain score in this period as seen in previous groin hernia studies. 4 Secondary end-points included: time to supplemental medication usage, average pain scores at individual intervals for the first 4 wk after surgery, area under the curve (AUC) pain scores from 4 h postoperatively to day 7 evening (AUC day 7 ), AUC during the first 4 wk after surgery (AUC week 4 ), and when (day and time) the AUC pain scores were no longer significantly different.…”

Section: Discussionmentioning

confidence: 99%

“…The aspartate aminotransferase elevations are in contrast to the previously reported studies of purified capsaicin where there were no treatment-related effects on laboratory safety variables. 12,13 However, the relatively small sample size was not powered to assess AEs.…”

Section: Discussionmentioning

confidence: 99%

“…12 However, other nonsurgical pain studies (intermetatarsal neuroma, lateral epicondylitis, and knee osteoarthritis) support the long-term analgesic effect of a purified capsaicin injection. [13][14][15] Similar to the bunionectomy study, 12 we successfully avoided the initial intense pain after purified capsaicin administration seen in other studies, [13][14][15] by first administering a local anesthetic.…”

Section: Discussionmentioning

confidence: 99%

“…The active study medication was purified (Ն98%) capsaicin (ALGRX 4975, Anesiva, Inc., South San Francisco, USA). Based upon safety and efficacy data from pilot studies, [12][13][14][15] an instillation of 1000 g purified capsaicin was chosen. Purified capsaicin was supplied as an open-label stock solution, and diluted with water for a maximum of 4 h before administration.…”

Section: Blinding Randomization and Study Medicationmentioning

confidence: 99%

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The Effect of Wound Instillation of a Novel Purified Capsaicin Formulation on Postherniotomy Pain: A Double-Blind, Randomized, Placebo-Controlled Study

Aasvang¹,

Hansen²,

Malmstrøm³

et al. 2008

Anesthesia &Amp; Analgesia

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Blinding Randomization and Study Medicationmentioning

confidence: 99%

See 2 more Smart Citations

The Effect of Wound Instillation of a Novel Purified Capsaicin Formulation on Postherniotomy Pain: A Double-Blind, Randomized, Placebo-Controlled Study

Aasvang¹,

Hansen²,

Malmstrøm³

et al. 2008

Anesthesia &Amp; Analgesia

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show abstract

“…The observed efficacy of capsaicin injections into knee joints in osteoarthritis appears to support this idea. Four out of five osteoarthritis patients injected intra-articularly with 1,000 μg of capsaicin exhibited reduced pain for a period of time between two and five weeks [66]. However, increased efficacy due to confinement of the agonist to a body compartment does not appear to be universally advantageous since instillation of RTX into the bladder has had a very mixed effect on interstitial cystitis [67–70].…”

Section: Introductionmentioning

confidence: 99%

Resiniferatoxin for Pain Treatment: An Interventional Approach to Personalized Pain Medicine

Iadarola¹,

Gonnella²

2013

TOPAINJ

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This review examines existing preclinical and clinical studies related to resiniferatoxin (RTX) and its potential uses in pain treatment. Like capsaicin, RTX is a vanilloid receptor (TRPV1) agonist, only more potent. This increased potency confers both quantitative and qualitative advantages in terms of drug action on the TRPV1 containing nerve terminal, which result in an increased efficacy and a long duration of action. RTX can be delivered by a central route of administration through injection into the subarachnoid space around the lumbosacral spinal cord. It can also be administered peripherally into a region of skin or deep tissue where primary afferents nerves terminate, or directly into a nerve trunk or a dorsal root ganglion. The central route is currently being evaluated as a treatment for intractable pain in patients with advanced cancer. Peripheral administration offers the possibility to treat a wide diversity of pain problems because of the ability to bring the treatment to the site of the pain (the peripheral generator). While not all pain disorders are appropriate for RTX, tailoring treatment to an individual patient's needs via a selective and local intervention that chemically targets a specific population of nerve terminals provides a new capability for pain therapy and a simplified and effective approach to personalized pain medicine.

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Screening for axonal retraction and cytotoxicity using dorsal root ganglia explants to treat pain caused by aberrant nerve sprouting

Lee,

Nguyen,

Munns

et al. 2023

Preprint

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Low back pain, knee osteoarthritis and cancer patients suffer from chronic pain. Aberrant nerve growth into intervertebral disc, knee, and tumors, are common pathologies that lead to these chronic pain conditions. Retraction of nerve fibers via capsaicin (Caps) or resiniferatoxin denervation have been used to treat painful neuropathies and knee osteoarthritis but with short-term efficacy and discomfort. Herein, we propose to repurpose pyridoxine (Pyr), vincristine sulfate (Vcr) and ionomycin (Imy) as potential axonal retraction compounds for denervation. Previous literature suggests Pyr, Vcr, and Imy each have undesired axonal degeneration as an off-target effect. Thus, we performed axonal retraction phenotype screening using adult rat dorsal root ganglia explants in vitro and assessed neurotoxicity. Imy did not induce axonal retraction, while Pyr and Vcr produced robust axonal retraction within three days. All DRGs treated with Caps, Pyr, Vcr, Imy or solvent had minimal neurotoxicity. Further, neither Pyr nor Vcr triggered nucleus pulposus cell death or affected cellular metabolic activity after three days of incubation. Overall, our findings suggest Pyr and Vcr are non-cytotoxic to dorsal root ganglia and nucleus pulposus cells, and there is potential for repurposing as axonal retraction compounds for local denervation.

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Preliminary safety, tolerability and efficacy of ALGRX 4975 in Osteoarthritis (OA) of the knee

Cited by 4 publications

References 0 publications

The Effect of Wound Instillation of a Novel Purified Capsaicin Formulation on Postherniotomy Pain: A Double-Blind, Randomized, Placebo-Controlled Study

The Effect of Wound Instillation of a Novel Purified Capsaicin Formulation on Postherniotomy Pain: A Double-Blind, Randomized, Placebo-Controlled Study

Resiniferatoxin for Pain Treatment: An Interventional Approach to Personalized Pain Medicine

Screening for axonal retraction and cytotoxicity using dorsal root ganglia explants to treat pain caused by aberrant nerve sprouting

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