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

Clinical Journal of Pain

Volumn 30, Issue 2, 2014, Pages 134-142

  Simpson, David M ^a   Brown, Stephen ^b   Tobias, Jeffrey K ^c   Vanhove, Geertrui F ^c   Martin, Mollen ^d   Sampson, James ^e   Gazda, Suzanne ^f   Brand, David ^g   Cutler, Barry ^h   Clifford, David ⁱ   Colson, Amy ^j   Ellis, Ronald ^k   Drusano, George ^l   Valcour, Victor ^m   Borkert, Claire ⁿ   McComsey, Grace ^o   Bartt, Russell ^p   De Jesus, Edwin ^q   Morris, Ann ⁱ   Myers, Robert ^r   Teinhart, Corklin ^s   So, Yuen ^t   Berger, Joe ^u   Hall, Colin ^v   McArthur, Justin ^w   Rubin, Michael ^x   Tselis, Alex ^y   Castro, Jose ^z   Rider, Dean ^aa   Brinson, Cynthia ^ab   Artin, Harold ^ac   Pierone, Gerald ^r   Diaz, Leslie ^ad   more..

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b NeurogesX Inc   (United States)

^c Arizona Clinical Research   (United States)

^d Research and Education Group   (United States)

^e Integra Clinical Research LLC   (United States)

^f Clinical Research   (United States)

^g Neurology Clinical Research Inc   (United States)

^h WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ Community Research Initiative of New England ^*  (United States)

^j UNIVERSITY OF CALIFORNIA   (United States)

^k AIDS Research Alliance   (United States)

^l ALBANY MEDICAL CENTER   (United States)

^m HACRP University of Hawaii   (United States)

ⁿ East Bay AIDS Center   (United States)

^o CASE WESTERN RESERVE UNIVERSITY   (United States)

^p Jr Hospital of Cook County   (United States)

^q ORLANDO IMMUNOLOGY CENTER   (United States)

^r Body Positive ^*  (United States)

^s Steinhart Medical Associates   (United States)

^t STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^u UNIVERSITY OF KENTUCKY   (United States)

^v UNIVERSITY OF NORTH CAROLINA   (United States)

^w JOHNS HOPKINS UNIVERSITY   (United States)

^x NEW YORK PRESBYTERIAN HOSPITAL   (United States)

^y WAYNE STATE UNIVERSITY   (United States)

^z UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^aa Rider Research Group   (United States)

^ab Central Texas Clinical Research   (United States)

^ac PARK NICOLLET CLINIC   (United States)

^ad Infectious Disease of the Palm Beaches Associates   (United States)

more..

Author keywords

capsaicin; HIV DSP; neuropathic pain

Indexed keywords

CAPSAICIN; LIDOCAINE; OXYCODONE;

ADULT; APPLICATION SITE BURNING; APPLICATION SITE DRYNESS; APPLICATION SITE PAIN; APPLICATION SITE PRURITUS; APPLICATION SITE REACTION; APPLICATION SITE SWELLING; APPLICATION SITE URTICARIA; APPLICATION SITE VESICLE; ARTICLE; CLINICIAN GLOBAL IMPRESSION OF CHANGE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GASTROENTERITIS; HIV ASSOCIATED DISTAL SENSORY POLYNEUROPATHY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NEUROPATHIC PAIN; NUMERIC PAIN RATING SCALE; OPEN STUDY; PAIN ASSESSMENT; PATIENT GLOBAL IMPRESSION OF CHANGE; PNEUMONIA; POLYNEUROPATHY; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RETREATMENT; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VOMITING; ANALGESIA; BIOASSAY; CLINICAL TRIAL; COMPLICATION; DRUG EFFECTS; KAPLAN MEIER METHOD; NEURALGIA; NEUROLOGIC EXAMINATION; PAIN MEASUREMENT; PATHOLOGY; PATIENT SATISFACTION; PERIPHERAL NERVOUS SYSTEM DISEASES; PROCEDURES; SENSORY NERVE CELL; SKIN; TRANSDERMAL PATCH;

ADULT; CAPSAICIN; DOUBLE-BLIND METHOD; ENDPOINT DETERMINATION; FEMALE; HIV INFECTIONS; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEURALGIA; NEUROLOGIC EXAMINATION; PAIN MANAGEMENT; PAIN MEASUREMENT; PATIENT SATISFACTION; PERIPHERAL NERVOUS SYSTEM DISEASES; SENSORY RECEPTOR CELLS; SKIN; TRANSDERMAL PATCH; TREATMENT OUTCOME;

EID: 84892951285     PISSN: 07498047     EISSN: 15365409     Source Type: Journal    
DOI: 10.1097/AJP.0b013e318287a32f     Document Type: Article

References (43)

1. Verma A. Epidemiology and clinical features of HIV-1 associated neuropathies. J Peripher Nerv Syst. 2001;6:8-13
2. Ellis RJ, Rosario D, Clifford DB, et al. Continued high prevalence and adverse clinical impact of human immunodeficiency virus-associated sensory neuropathy in the era of combination antiretroviral therapy: The CHARTER Study. Arch Neurol. 2010;67:552-558
3. Simpson DM, Tagliati M. Nucleoside analogue-associated peripheral neuropathy in human immunodeficiency virus infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1995; 9:153-161
4. Morgello S, Estanislao L, Simpson D, et al. HIV-associated distal sensory polyneuropathy in the era of highly active antiretroviral therapy: The Manhattan HIV Brain Bank. Arch Neurol. 2004;61:546-551
5. Keswani SC, Pardo CA, Cherry CL, et al. HIV-associated sensory neuropathies. AIDS. 2002;16:2105-2117
6. Hewitt DJ, McDonald M, Portenoy RK, et al. Pain syndromes and etiologies in ambulatory AIDS patients. Pain. 1997; 70:117-123
7. Simpson DM, Kitch D, Evans SR, et al. HIV neuropathy natural history cohort study: Assessment measures and risk factors. Neurology. 2006;66:1679-1687
8. Gonzalez-Duarte A, Robinson-Papp J, Simpson DM. Diagnosis and management of HIV-associated neuropathy. Neurol Clin. 2008;26:821-832
9. Verma S, Estanislao L, Mintz L, et al. Controlling neuropathic pain in HIV. Curr Infect Dis Rep. 2004;6:237-242
10. Frich LM, Borgbjerg FM. Pain and pain treatment in AIDS patients: A longitudinal study. J Pain Symptom Manage. 2000;19:339-347
11. Breitbart W, Rosenfeld BD, Passik SD, et al. The undertreatment of pain in ambulatory AIDS patients. Pain. 1996;65:243-249
12. Breitbart W, Passik S, McDonald MV, et al. Patient-related barriers to pain management in ambulatory AIDS patients. Pain. 1998;76:9-16
13. Simpson DM, Schifitto G, Clifford DB, et al. Pregabalin for painful HIV neuropathy: A randomized, double-blind, placebocontrolled trial. Neurology. 2010;74:413-420
14. Szallasi A, Blumberg PM. Vanilloid (capsaicin) receptors and mechanisms. Pharmacol Rev. 1999;51:159-212
15. Cortright DN, Szallasi A. Biochemical pharmacology of the vanilloid receptor TRPV1. An update. Eur J Biochem. 2004; 271:1814-1819
16. Facer P, Casula MA, Smith GD, et al. Differential expression of the capsaicin receptor TRPV1 and related novel receptors TRPV3, TRPV4 and TRPM8 in normal human tissues and changes in traumatic and diabetic neuropathy. BMC Neurol. 2007;7:11
17. Petersen KL, Fields HL, Brennum J, et al. Capsaicin evoked pain and allodynia in post-herpetic neuralgia. Pain. 2000; 88:125-133
18. Wilder-Smith EP, Ong WY, Guo Y, et al. Epidermal transient receptor potential vanilloid 1 in idiopathic small nerve fibre disease, diabetic neuropathy and healthy human subjects. Histopathology. 2007;51:674-680
19. Kennedy WR, Vanhove GF, Lu SP, et al. A randomized, controlled, open-label study of the long-term effects of NGX-4010, a high-concentration capsaicin patch, on epidermal nerve fiber density and sensory function in healthy volunteers. J Pain. 2010;11:579-587
20. Anand P, Bley K. Topical capsaicin for pain management: Therapeutic potential and mechanisms of action of the new high-concentration capsaicin 8% patch. Br J Anaesth. 2011; 107:490-502
21. Zhang WY, Li Wan PA. The effectiveness of topically applied capsaicin. A meta-analysis. Eur J Clin Pharmacol. 1994;46: 517-522
22. Kingery WS. A critical review of controlled clinical trials for peripheral neuropathic pain and complex regional pain syndromes. Pain. 1997;73:123-139
23. Paice JA, Ferrans CE, Lashley FR, et al. Topical capsaicin in the management of HIV-associated peripheral neuropathy. J Pain Symptom Manage. 2000;19:45-52
24. McCormack PL. Capsaicin dermal patch: In non-diabetic peripheral neuropathic pain. Drugs. 2010;70:1831-1842
25. Simpson DM, Estanislao L, Brown SJ, et al. An open-label pilot study of high-concentration capsaicin patch in painful HIV neuropathy. J Pain Symptom Manage. 2008;35:299-306
26. Simpson DM, Brown S, Tobias J. Controlled trial of highconcentration capsaicin patch for treatment of painful HIV neuropathy. Neurology. 2008;70:2305-2313
27. Farrar JT, Young JP Jr., LaMoreaux L, et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94:149-158
28. US Food and Drug Administration Center for Drug Evaluation and Research. Guidance for industry: Skin irritation and sensitization testing of generic transdermal drug products. 1999. Available at: Www.fda.gov/ohrms/dockets/98fr/ 990236Gd.pdf# search=%22HillTop%20Research%2C%20Inc.%20dermal% 20irritation%22. Accessed July 20 2012
29. Irving GA, Backonja MM, Dunteman E, et al. A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. Pain Med. 2011;12:99-109
30. Backonja MM, Malan TP, Vanhove GF, et al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: A randomized, double-blind, controlled study with an open-label extension. Pain Med. 2010;11:600-608
31. Nolano M, Simone DA, Wendelschafer-Crabb G, et al. Topical capsaicin in humans: Parallel loss of epidermal nerve fibers and pain sensation. Pain. 1999;81:135-145
32. Bley KR. Recent developments in transient receptor potential vanilloid receptor 1 agonist-based therapies. Expert Opin Investig Drugs. 2004;13:1445-1456
33. Paterson DL, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000;133:21-30
34. Babbar S, Marier JF, Mouksassi MS, et al. Pharmacokinetic analysis of capsaicin after topical administration of a highconcentration capsaicin patch to patients with peripheral neuropathic pain. Ther Drug Monit. 2009;31:502-510
35. Lee YS, Kho HS, Kim YK, et al. Influence of topical capsaicin on facial sensitivity in response to experimental pain. J Oral Rehabil. 2007;34:9-14
36. Tominaga M. Nociception and TRP channels. Handb Exp Pharmacol. 2007;179:489-505
37. Schifitto G, Yiannoutsos CT, Simpson DM, et al. A placebocontrolled study of memantine for the treatment of human immunodeficiency virus-associated sensory neuropathy. J Neurovirol. 2006;12:328-331
38. Estanislao L, Carter K, McArthur J, et al. A randomized controlled trial of 5% lidocaine gel for HIV-associated distal symmetric polyneuropathy. J Acquir Immune Defic Syndr. 2004;37:1584-1586
39. Simpson DM, McArthur JC, Olney R, et al. Lamotrigine for HIV-associated painful sensory neuropathies: A placebocontrolled trial. Neurology. 2003;60:1508-1514
40. Kieburtz K, Simpson D, Yiannoutsos C, et al. AIDS Clinical Trial Group 242 Protocol Team. A randomized trial of amitriptyline and mexiletine for painful neuropathy in HIV infection. Neurology. 1998;51:1682-1688
41. Hahn K, Arendt G, Braun JS, et al. A placebo-controlled trial of gabapentin for painful HIV-associated sensory neuropathies. J Neurol. 2004;251:1260-1266
42. Abrams DI, Jay CA, Shade SB, et al. Cannabis in painful HIV-associated sensory neuropathy: A randomized placebocontrolled trial. Neurology. 2007;68:515-521
43. Ellis RJ, Toperoff W, Vaida F, et al. Smoked medicinal cannabis for neuropathic pain in HIV: A randomized, crossover clinical trial. Neuropsychopharmacology. 2009;34:672-680