NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: results of a 52-week open-label study.

Clin J Pain

*Clinical Neurophysiology Laboratories and Neuro-AIDS Program, Department of Neurology, The Mount Sinai Medical Center, New York, NY †AIDS Research Alliance, Los Angeles, CA ‡NeurogesX Inc., San Mateo, CA.

Published: February 2014

Objectives: To evaluate the efficacy, safety, and tolerability of repeated NGX-4010 treatments in the open-label extension phase of a 52-week study in patients with neuropathic pain due to HIV-associated distal sensory polyneuropathy (HIV-DSP).

Methods: Patients completing the 12-week, randomized, double-blind phase of the study could enter a 40-week, open-label phase, and receive up to 3, 60-minute NGX-4010 treatments. Patients recorded their "average pain for the past 24 hours" daily using the Numeric Pain Rating Scale (NPRS). Efficacy assessment included the percentage NPRS score reduction from baseline to weeks 2 to 12 after the final treatment, and Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) questionnaires at study termination.

Results: Of 307 patients randomized, 272 entered the open-label phase; 81, 90, 55, and 46 received 0, 1, 2, and 3 retreatments, respectively. The mean percentage decrease in NPRS score from baseline to weeks 2 to 12 after the final treatment was similar in patients receiving single or multiple NGX-4010 treatments (-25.8%, -27.1%, -24.6%, and -22.7% for 1, 2, 3, and 4 NGX-4010 treatments, respectively). PGIC and CGIC results demonstrated a benefit of NGX-4010 treatment through to the end of the study regardless of the number of treatments received. Transient local application site reactions were the most frequently reported adverse events, and were mainly mild to moderate, nonserious, and did not increase with repeated treatment.

Discussion: Repeated NGX-4010 treatments were generally well tolerated and resulted in consistent reductions in HIV-DSP-associated pain and improvement in patient-reported outcomes.

Download full-text PDF

Source
http://dx.doi.org/10.1097/AJP.0b013e318287a32fDOI Listing

Publication Analysis

Top Keywords

ngx-4010 treatments
20
hiv-associated distal
8
distal sensory
8
sensory polyneuropathy
8
repeated ngx-4010
8
open-label phase
8
nprs score
8
baseline weeks
8
weeks final
8
final treatment
8

Similar Publications

TRPA1 is a homotetrameric non-selective calcium-permeable channel. It contributes to chemical and temperature sensitivity, acute pain sensation, and development of inflammation. HCIQ2c1 is a peptide from the sea anemone that inhibits serine proteases.

View Article and Find Full Text PDF

The present investigation evaluated transcutaneous electrical nerve stimulation (TENS) for the non-pharmacological treatment of post-herpetic neuralgia (PHN). PHN is the most common complication of the Herpes Zoster virus, affecting one in every five patients with shingles, and presents as intense neuropathic pain that can persist for 90 days or longer after the initial onset of symptoms. Current pharmacological treatment options are mainly limited to symptom management, including oral medications such as tricyclic antidepressants and gabapentinoid preparations, as well as topical options such as lidocaine or capsaicin.

View Article and Find Full Text PDF

Purpose: Corneal pain is one of the most common eye symptoms caused by various types of epithelial injuries, including traumatic abrasion, chemical injury, ulcers, ultraviolet exposure, and infection. However, current therapeutic options for corneal pain are limited. In this study, we synthesized a novel quaternary ammonium compound, N-propylamiodarone bromide (NPA), and employed a rodent model of corneal injury to investigate whether NPA offers prolonged corneal analgesia through transient receptor potential vanilloid 1 (TRPV1) channel-mediated selective cellular entry, without hindering corneal epithelial recovery.

View Article and Find Full Text PDF

Background And Purpose: Irritable bowel syndrome (IBS) is a common condition that is challenging to treat, and novel drugs are needed for this condition. Previously, a chronic vicarious social defeat stress (cVSDS) mouse model exhibits IBS-like symptoms. Also agonists of the opioid δ-receptor exert anti-stress effects in rodents with minimal adverse effects.

View Article and Find Full Text PDF

The objective of this study was to evaluate the effects of supplementing an essential oil blend (0.16 g/kg DM of carvacrol, eugenol, thymol, and capsaicin) and monensin (17.6 mg/kg DM TMR) on lactation performance, feeding behavior, and rumen fermentation of high-producing dairy cows.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!