PMID- 22328830
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20121002
LR  - 20220409
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 5
DP  - 2012
TI  - Tolerability of NGX-4010, a capsaicin 8% patch, in conjunction with three topical 
      anesthetic formulations for the treatment of neuropathic pain.
PG  - 7-13
LID - 10.2147/JPR.S25272 [doi]
AB  - BACKGROUND: The objective of this study was to assess the safety, tolerability, 
      and preliminary efficacy of NGX-4010, a capsaicin 8% patch, following 
      pretreatment with three different topical anesthetics in patients with peripheral 
      neuropathic pain. METHODS: This open-label, multicenter study enrolled 117 
      patients with post-herpetic neuralgia, HIV-associated distal sensory 
      polyneuropathy, or painful diabetic neuropathy. Patients received pretreatment 
      with one of three lidocaine 4%-based topical anesthetics (L.M.X.4((R)) [Ferndale 
      Laboratories Inc, Ferndale, MI], Topicaine((R)) Gel [Estela Basso, Jupiter, FL], or 
      Betacaine Enhanced Gel 4 [Tiberius Inc, Tampa, FL]) for 60 minutes followed by a 
      single 60- or 90-minute NGX-4010 application, and were followed for 12 weeks. 
      Tolerability and safety measures included "pain now" Numeric Pain Rating Scale 
      (NPRS) scores, dermal assessments, medication use for treatment-related pain, 
      adverse events (AEs), clinical laboratory parameters, physical examinations, and 
      vital signs. The primary efficacy variable was the percentage change in mean NPRS 
      scores for "average pain for the past 24 hours" from baseline to weeks 2 through 
      12. RESULTS: Treatment with NGX-4010 following pretreatment with any of the three 
      topical anesthetics was generally safe and well tolerated. Nearly all patients 
      completed >/=90% of the planned NGX-4010 application duration. The most common 
      treatment-related AEs, application-site burning and application-site pain, were 
      transient, mostly mild or moderate, and could be adequately managed by local 
      cooling or short-acting oral opioid analgesics. Although slightly more patients 
      used medication for treatment-related discomfort following pretreatment with 
      Topicaine compared with L.M.X.4 or Betacaine, there were no statistical 
      differences between the topical anesthetics. Neuropathic pain reduction from 
      baseline to weeks 2 through 12 was approximately 30% and was similar among the 
      topical anesthetics; the proportion of responders ranged from 45% to 50%. 
      CONCLUSION: Treatment with NGX-4010 following pretreatment with any of the three 
      topical anesthetics was generally safe and well tolerated; no significant 
      differences in the parameters measured were noted between the pretreatment 
      groups.
FAU - Webster, Lynn R
AU  - Webster LR
AD  - Lifetree Clinical Research and Pain Clinic, Lifetree Medical Inc, Salt Lake City, 
      UT, USA.
FAU - Peppin, John F
AU  - Peppin JF
FAU - Murphy, Frederick T
AU  - Murphy FT
FAU - Tobias, Jeffrey K
AU  - Tobias JK
FAU - Vanhove, Geertrui F
AU  - Vanhove GF
LA  - eng
PT  - Journal Article
DEP - 20120120
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC3273402
OTO - NOTNLM
OT  - capsaicin patch
OT  - neuropathic pain
OT  - tolerability
OT  - topical anesthetics
EDAT- 2012/02/14 06:00
MHDA- 2012/02/14 06:01
PMCR- 2012/01/20
CRDT- 2012/02/14 06:00
PHST- 2012/02/14 06:00 [entrez]
PHST- 2012/02/14 06:00 [pubmed]
PHST- 2012/02/14 06:01 [medline]
PHST- 2012/01/20 00:00 [pmc-release]
AID - jpr-5-007 [pii]
AID - 10.2147/JPR.S25272 [doi]
PST - ppublish
SO  - J Pain Res. 2012;5:7-13. doi: 10.2147/JPR.S25272. Epub 2012 Jan 20.