Bottlenecks in the development of topical analgesics: molecule, formulation, dose-finding, and phase III design

References

• BernsteinJEWhitneyDHSoltaniKInhibition of histamine-induced pruritus by topical tricyclic antidepressantsJ Am Acad Dermatol1981555825857298924
   PubMed Web of Science ®Google Scholar
• ButlerSHWeil-FugazzaJGodefroyFBessonJMReduction of arthritis and pain behaviour following chronic administration of amitriptyline or imipramine in rats with adjuvant-induced arthritisPain19852321591754069719
   PubMed Web of Science ®Google Scholar
• ArdidDEschalierALavarenneJEvidence for a central but not a peripheral analgesic effect of clomipramine in ratsPain1991451951001861881
   PubMed Web of Science ®Google Scholar
• SuXGebhartGFEffects of tricyclic antidepressants on mechanosensitive pelvic nerve afferent fibers innervating the rat colonPain1998761–21051149696463
   PubMed Web of Science ®Google Scholar
• SawynokJReidAREsserMJPeripheral antinociceptive action of amitriptyline in the rat formalin test: involvement of adenosinePain1999801–2455510204717
   PubMed Web of Science ®Google Scholar
• EsserMJSawynokJAcute amitriptyline in a rat model of neuropathic pain: differential symptom and route effectsPain199980364365310342426
   PubMed Web of Science ®Google Scholar
• SawynokJEsserMJReidARPeripheral antinociceptive actions of desipramine and fluoxetine in an inflammatory and neuropathic pain test in the ratPain199982214915810467920
   PubMed Web of Science ®Google Scholar
• KopskyDJHesselinkJMHigh doses of topical amitriptyline in neuropathic pain: two cases and literature reviewPain Pract201212214815321676162
   PubMed Web of Science ®Google Scholar
• LynchMEClarkAJSawynokJA pilot study examining topical amitriptyline, ketamine, and a combination of both in the treatment of neuropathic painClin J Pain200319532332812966259
   PubMed Web of Science ®Google Scholar
• RainsCBrysonHMTopical capsaicin. A review of its pharmacological properties and therapeutic potential in post-herpetic neuralgia, diabetic neuropathy and osteoarthritisDrugs Aging1995743173288535059
   PubMed Web of Science ®Google Scholar
• GalerBSRowbothamMCPeranderJFriedmanETopical lidocaine patch relieves postherpetic neuralgia more effectively than a vehicle topical patch: results of an enriched enrollment studyPain199980353353810342414
   PubMed Web of Science ®Google Scholar
• Keppel HesselinkJMKopskyDJSajbenNNew topical treatment of vulvodynia based on the pathogenetic role of cross talk between nociceptors, immunocompetent cells, and epithelial cellsJ Pain Res2016975776227757050
   PubMed Web of Science ®Google Scholar
• Keppel HesselinkJMKopskyDJTopical analgesic creams and nociception in diabetic neuropathy: towards a rationale fundamentClin Case Rep Rev201627500502
   Google Scholar
• GilronIBaileyJMTuDHoldenRRJacksonACHouldenRLNortriptyline and gabapentin, alone and in combination for neuropathic pain: a double-blind, randomised controlled crossover trialLancet200937496971252126119796802
   PubMed Web of Science ®Google Scholar
• GilronIBailyJTuDMorphine, gabapentin, or their combination for neuropathic painN Engl J Med2005352131324133415800228
   PubMed Web of Science ®Google Scholar
• GilronIChaparroLETuDCombination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trialPain201615771532154026982602
   PubMed Web of Science ®Google Scholar
• GilronITuDHoldenRRJacksonACDuMerton-ShoreDCombination of morphine with nortriptyline for neuropathic painPain201515681440144825749306
   PubMed Web of Science ®Google Scholar
• KopskyDJKeppel HesselinkJMBhaskarAHaritonGRomanenkoVCasaleRAnalgesic effects of topical ketamineMinerva Anestesiol201581444044924847738
   PubMed Web of Science ®Google Scholar
• KopskyDJKeppel HesselinkJMNeuropathic pain as a result of acromegaly, treated with topical baclofen creamJ Pain Symptom Manage2013464e4e524103474
   PubMed Web of Science ®Google Scholar
• MugglestoneCJMarizSLaneMEThe development and registration of topical pharmaceuticalsInt J Pharm20124351222622486961
   PubMed Web of Science ®Google Scholar
• VanottiAOsioMMaillandENascimbeneCCapiluppiEMarianiCOverview on pathophysiology and newer approaches to treatment of peripheral neuropathiesCNS Drugs20072131217696588
   PubMed Web of Science ®Google Scholar
• KopskyDJKeppel HesselinkJMTopical phenytoin for the treatment of neuropathic painJ Pain Res20171046947328280381
   PubMed Web of Science ®Google Scholar
• Keppel HesselinkJMKopskyDJBhaskarAKSkin matters! The role of keratinocytes in nociception: a rational argument for the development of topical analgesicsJ Pain Res2016101828031725
   PubMed Web of Science ®Google Scholar
• LeeGXiangZBrannaganTH3rdChinRLLatovNDifferential gene expression in chronic inflammatory demyelinating polyneuropathy (CIDP) skin biopsiesJ Neurol Sci20102901–211512219922956
   PubMed Web of Science ®Google Scholar
• BirkleinFDrummondPDLiWActivation of cutaneous immune responses in complex regional pain syndromeJ Pain201415548549524462502
   PubMed Web of Science ®Google Scholar
• Van AckerNRagéMVermeirschHNRP-1 Receptor expression mismatch in skin of subjects with experimental and diabetic small fiber neuropathyPLoS One2016119e016144127598321
   PubMed Web of Science ®Google Scholar
• DrummondESMakerGBirkleinFFinchPMDrummondPDTopical prazosin attenuates sensitivity to tactile stimuli in patients with complex regional pain syndromeEur J Pain201620692693526568465
   PubMed Web of Science ®Google Scholar
• Keppel HesselinkJMKopskyDJTreatment of chronic regional pain syndrome type 1 with palmitoylethanolamide and topical ketamine cream: modulation of nonneuronal cellsJ Pain Res2013623924523658493
   PubMed Web of Science ®Google Scholar
• FinchPMKnudsenLDrummondPDReduction of allodynia in patients with complex regional pain syndrome: a double-blind placebo-controlled trial of topical ketaminePain20091461–2182519703730
   PubMed Web of Science ®Google Scholar
• RussoMASantarelliDMA novel compound analgesic cream (Ketamine, Pentoxifylline, Clonidine, DMSO) for complex regional pain syndrome patientsPain Pract2016161E14E2026547813
   PubMed Web of Science ®Google Scholar
• GewandterJSMohileSGHecklerCEA phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study of 462 cancer survivorsSupport Care Cancer20142271807181424531792
   PubMed Web of Science ®Google Scholar
• ScottMALetrentKJHagerKLBurchJLUse of transdermal amitriptyline gel in a patient with chronic pain and depressionPharmacotherapy199919223623910030776
   PubMed Web of Science ®Google Scholar
• QuanDWellishMGildenDHTopical ketamine treatment of postherpetic neuralgiaNeurology20036081391139212707455
   PubMed Web of Science ®Google Scholar
• WillimannHWaldePLuisiPLGazzanigaAStroppoloFLecithin organogel as matrix for transdermal transport of drugsJ Pharm Sci19928198718741432631
   PubMed Web of Science ®Google Scholar
• MahoneyJMVardaxisVMooreJLHallAMHaffnerKEPetersonMCTopical ketamine cream in the treatment of painful diabetic neuropathy: a randomized, placebo-controlled, double-blind initial studyJ Am Podiatr Med Assoc2012102317818322659759
   PubMed Web of Science ®Google Scholar
• BartonDLWosEJQinRA double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CASupport Care Cancer201119683384120496177
   PubMed Web of Science ®Google Scholar
• KopskyDJExtending the therapeutic scope for the treatment of neuropathic pain with topical analgesicsJ Pain Relief201653251252
   Google Scholar
• Keppel HesselinkJMThinking out of the pillbox: the relevance to topiceuticals in the treatment of neuropathic painJ Pain Relief20166513
   Google Scholar
• DworkinRHTurkDCPeirce-SandnerSResearch design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendationsPain2010149217719320207481
   PubMed Web of Science ®Google Scholar
• FarrarJTPortenoyRKBerlinJAKinmanJLStromBLDefining the clinically important difference in pain outcome measuresPain200088328729411068116
   PubMed Web of Science ®Google Scholar