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Role of Duloxetine in Neuropathic Pain: A Clinical Impact, Mechanism, Challenges in Formulation Development to Safety Concern


Affiliations
1 School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab,, India
2 Topicals Research and Development, Amneal Pharmaceuticals, Piscataway, New Jersey,, United States
     

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Neuropathic pain (NP) is a dreadful disease of the somatosensory nervous system with many etiologies. The antidepressant drug is recommended as the first-line drug for the management of such pain. Duloxetine (DXH) is one of the classes of antidepressant drugs having an efficient use in mild to severe pain management. There are many clinical studies conducted on DXH and tested for its effectiveness in NP. For this review articles were collected from PubMed, Science Direct, goggle scholar, and other relevant sites. This review is based on the recently updated articles on duloxetine. The inclusion criteria for this was an English, clinical study with a year of publication between mostly 2010-2020, the DXH and its treatment of NP, comparison of DXH with another drug for the treatment of NP. The only exclusion criteria for this review is the preclinical study. The study design (randomized, cross-sectional, double-blinded), compound DXH regime, outcome measure of the study, and the efficacy were taken into consideration. The present review focused on the molecular targets, challenges, formulation development, comparison with some other drugs in terms of therapeutic benefits, and tolerance with the safety issue of DXH. It was found that DXH provides impactful relief from pain but still modification in the treatment strategies for NP is required.

Keywords

Depression, Neuropathic pain, Duloxetine, Clinical pattern.
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  • Blyth FM 2018. Global burden of neuropathic pain. Pain 159(3):614-617.

  • Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpää M, Hansson P, Jensen TS 2015. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. The Lancet Neurology 14(2):162-173.

  • Colloca L, Ludman T, Bouhassira D, Baron R, Dickenson AH, Yarnitsky D, Freeman R, Truini A, Attal N, Finnerup NB 2017. Neuropathic pain. Nature reviews Disease primers 3(1):1-19.

  • Cruccu G, Finnerup NB, Jensen TS, Scholz J, Sindou M, Svensson P, Treede R-D, Zakrzewska JM, Nurmikko T 2016. Trigeminal neuralgia: new classification and diagnostic grading for practice and research. Neurology 87(2):220-228.

  • Otis J, Macone A 2018. Neuropathic pain. Semin Neurol 38:644-653.

  • Bannister K, Sachau J, Baron R, Dickenson AH 2020. Neuropathic pain: mechanism-based therapeutics. Annual Review of Pharmacology and Toxicology 60:257-274.

  • Cruccu G, Truini A 2017. A review of neuropathic pain: from guidelines to clinical practice. Pain and therapy 6(1):35-42.

  • Gilron I, Baron R, Jensen T. Mayo Clinic Proceedings, 2015, pp 532-545. 9. Attal N 2019. Pharmacological treatments of neuropathic pain: The latest recommendations. Revue Neurologique 175(1-2):46-50.

  • Attal N, Jazat F, Kayser V, Guilbaud G 1990. Further evidence for ‘pain-related’behaviours in a model of unilateral peripheral mononeuropathy. Pain 41(2):235-251.

  • Baron R, Maier C, Attal N, Binder A, Bouhassira D, Cruccu G, Finnerup NB, Haanpää M, Hansson P, Hüllemann P 2017. Peripheral neuropathic pain: a mechanism-related organizing principle based on sensory profiles. Pain 158(2):261.

  • Colloca L, Ludman T, Bouhassira D, Baron R, Dickenson AH, Yarnitsky D, Freeman R, Truini A, Attal N, Finnerup NB 2017. Neuropathic pain. Nature reviews Disease primers 3:17002.

  • Haanpää M, Attal N, Backonja M, Baron R, Bennett M, Bouhassira D, Cruccu G, Hansson P, Haythornthwaite JA, Iannetti GD 2011. NeuPSIG guidelines on neuropathic pain assessment. PAIN® 152(1):14-27.

  • Cavaliere F, Fornarelli A, Bertan F, Russo R, Marsal-Cots A, Morrone LA, Adornetto A, Corasaniti MT, Bano D, Bagetta G 2019. The tricyclic antidepressant clomipramine inhibits neuronal autophagic flux. Scientific reports 9(1):1-9.

  • Banzi R, Cusi C, Randazzo C, Sterzi R, Tedesco D, Moja L 2015. Selective serotonin reuptake inhibitors (SSRIs) and serotonin‐norepinephrine reuptake inhibitors (SNRIs) for the prevention of migraine in adults. Cochrane Database of Systematic Reviews (4).

  • Magrinelli F, Zanette G, Tamburin S 2013. Neuropathic pain: diagnosis and treatment. Practical neurology 13(5):292-307.

  • Finnerup NB, Sindrup SH, Jensen TS 2010. The evidence for pharmacological treatment of neuropathic pain. Pain 150(3):573-581.

  • Attal N, Cruccu G, Baron Ra, Haanpää M, Hansson P, Jensen T, Nurmikko T 2010. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. European Journal of Neurology 17(9):1113-e1188.

  • Ye W, Zhao Y, Robinson RL, Swindle RW 2011. Treatment patterns associated with Duloxetine and Venlafaxine use for Major Depressive Disorder. BMC psychiatry 11(1):19.

  • Tesfaye S, Wilhelm S, Lledo A, Schacht A, Tölle T, Bouhassira D, Cruccu G, Skljarevski V, Freynhagen R 2013. Duloxetine and pregabalin: high-dose monotherapy or their combination? The “COMBO-DN study”–a multinational, randomized, double-blind, parallel-group study in patients with diabetic peripheral neuropathic pain. PAIN® 154(12):2616-2625.

  • Smith EML, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N 2013. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. Jama 309(13):1359-1367.

  • Bradley LA, Bennett R, Russell IJ, Wohlreich MM, Chappell AS, Wang F, D'Souza DN, Moldofsky H 2010. Effect of duloxetine in patients with fibromyalgia: tiredness subgroups. Arthritis Research & Therapy 12(4):R141.

  • Patel K, Padhye S, Nagarsenker M 2012. Duloxetine HCl lipid nanoparticles: preparation, characterization, and dosage form design. Aaps Pharmscitech 13(1):125-133.

  • Cordell WH 1999. Number needed to treat (NNT). Annals of emergency medicine 33(4):433-436.

  • Cook RJ, Sackett DL 1995. The number needed to treat: a clinically useful measure of treatment effect. Bmj 310(6977):452-454.

  • Finnerup NB, Otto M, McQuay H, Jensen T, Sindrup SH 2005. Algorithm for neuropathic pain treatment: an evidence based proposal. Pain 118(3):289-305.

  • Vuppalanchi R, Hayashi P, Chalasani N, Fontana RJ, Bonkovsky H, Saxena R, Kleiner D, Hoofnagle JH 2010. Duloxetine hepatotoxicity: a case‐series from the drug‐induced liver injury network. Alimentary pharmacology & therapeutics 32(9):1174-1183.

  • Chhalotiya UK, Bhatt KK, Shah DA, Baldania SL 2010. Development and validation of a stability-indicating RP-HPLC method for duloxetine hydrochloride in its bulk and tablet dosage form. Scientia pharmaceutica 78(4):857-868.

  • Laha T, Mishra G, Sen S 2013. High-Performance Liquid Chromatographic Analysis of Duloxetine and Its Metabolites in Rat and Characterization of Metabolites in Plasma, Urine, Feces and Bile through Retro-Synthesis Followed By NMR and MS Study. International Journal of Pharmaceutical Sciences and Drug Research 5(2):70-77.

  • Patel A, Shelat P, Lalwani A 2014. Development and optimization of solid self-nanoemulsifying drug delivery system (S-SNEDDS) using Scheffe’s design for improvement of oral bioavailability of nelfinavir mesylate. Drug Delivery and Translational Research 4(2):171-186.

  • Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P 1990. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Arthritis & Rheumatology 33(2):160-172.

  • Sun Y-H, Dong Y-L, Wang Y-T, Zhao G-L, Lu G-J, Yang J, Wu S-X, Gu Z-X, Wang W 2013. Synergistic analgesia of duloxetine and celecoxib in the mouse formalin test: a combination analysis. PloS one 8(10):e76603.

  • De Berardis D, Serroni N, Carano A, Scali M, Valchera A, Campanella D, D’Albenzio A, Di Giuseppe B, Moschetta FS, Salerno RM 2008. The role of duloxetine in the treatment of anxiety disorders. Neuropsychiatric Disease and Treatment 4(5):929.

  • Perahia D, Kajdasz D, Walker D, Raskin J, Tylee A 2006. Duloxetine 60 mg once daily in the treatment of milder major depressive disorder. International Journal of Clinical Practice 60(5):613-620.

  • Ganesh M, Ubaidulla U, Hemalatha P, Peng MM, Jang HT 2015. Development of duloxetine hydrochloride loaded mesoporous silica nanoparticles: characterizations and in vitro evaluation. AAPS PharmSciTech 16(4):944-951.

  • Kumar N, Sangeetha D, Sunil Reddy P, Malleswara Reddy A 2012. Development and validation of a dissolution test for delayed release capsule formulation of duloxetine hydrochloride. Current Pharmaceutical Analysis 8(3):236-246.

  • Sagman D, McIntosh D, Lee M, Li H, Ruschel S, Hussain N, Granger R, Lee A, Raskin J 2011. Attributes of response in depressed patients switched to treatment with duloxetine. International Journal of Clinical Practice 65(1):73-81.

  • Katsuyama S, Aso H, Otowa A, Yagi T, Kishikawa Y, Komatsu T, Sakurada T, Nakamura H 2014. Antinociceptive Effects of the Serotonin and Noradrenaline Reuptake Inhibitors Milnacipran and Duloxetine on Vincristine-Induced Neuropathic Pain Model in Mice. ISRN Pain 2014.

  • Goldstein DJ 2007. Duloxetine in the treatment of major depressive disorder. Neuropsychiatric Disease and Treatment 3(2):193.

  • Kumar RS, Challa SR, Babu GL, Rekha K, Devi VR, Srinu S, Challa VR, Babu SN 2013. Influence of Duloxetine on the in-vivo pharmacokinetics of Metoprolol in rat model. Journal of Pharmacy Research 7(4):362-366.

  • Shelton RC. 2018. Serotonin and norepinephrine reuptake inhibitors. Antidepressants, ed.: Springer. p 145-180.

  • Sun T, Li B, Nie Y, Wang D, Xu Y 2017. Enhancement of asymmetric bioreduction of N, N-dimethyl-3-keto-3-(2-thienyl)-1-propanamine to corresponding (S)-enantiomer by fusion of carbonyl reductase and glucose dehydrogenase. Bioresources and Bioprocessing 4(1):1-10.

  • Sinatra RS, Jahr JS, Watkins-Pitchford JM. 2010. The essence of analgesia and analgesics. ed.: Cambridge University Press.

  • Bymaster FP, Lee TC, Knadler MP, Detke MJ, Iyengar S 2005. The dual transporter inhibitor duloxetine: a review of its preclinical pharmacology, pharmacokinetic profile, and clinical results in depression. Current pharmaceutical design 11(12):1475-1493.

  • Turcotte JE, Debonnel G, de Montigny C, Hébert C, Blier P 2001. Assessment of the serotonin and norepinephrine reuptake blocking properties of duloxetine in healthy subjects. Neuropsychopharmacology 24(5):511-521.

  • Chalon SA, Granier L-A, Vandenhende FR, Bieck PR, Bymaster FP, Joliat MJ, Hirth C, Potter WZ 2003. Duloxetine increases serotonin and norepinephrine availability in healthy subjects: a double-blind, controlled study. Neuropsychopharmacology 28(9):1685-1693.

  • Singh A, Bali A 2016. Formulation and characterization of transdermal patches for controlled delivery of duloxetine hydrochloride. Journal of Analytical Science and Technology 7(1):1-13.

  • Slatter J, Stalker D, Feenstra K, Welshman I, Bruss J, Sams J, Johnson M, Sanders P, Hauer M, Fagerness P 2001. Pharmacokinetics, metabolism, and excretion of linezolid following an oral dose of [14C] linezolid to healthy human subjects. Drug Metabolism and Disposition 29(8):1136-1145.

  • Kremer M, Yalcin I, Goumon Y, Wurtz X, Nexon L, Daniel D, Megat S, Ceredig RA, Ernst C, Turecki G 2018. A dual noradrenergic mechanism for the relief of neuropathic allodynia by the antidepressant drugs duloxetine and amitriptyline. Journal of Neuroscience 38(46):9934-9954.

  • Yam MF, Loh YC, Tan CS, Khadijah Adam S, Abdul Manan N, Basir R 2018. General pathways of pain sensation and the major neurotransmitters involved in pain regulation. International Journal of Molecular Sciences 19(8):2164.

  • Cohen SP, Mao J 2014. Neuropathic pain: mechanisms and their clinical implications. Bmj 348.

  • Pan H-L, Wu Z-Z, Zhou H-Y, Chen S-R, Zhang H-M, Li D-P 2008. Modulation of pain transmission by G-protein-coupled receptors. Pharmacology & Therapeutics 117(1):141-161.

  • Obata H 2017. Analgesic mechanisms of antidepressants for neuropathic pain. International Journal of Molecular Sciences 18(11):2483.

  • Viguier F, Michot B, Hamon M, Bourgoin S 2013. Multiple roles of serotonin in pain control mechanisms—implications of 5-HT7 and other 5-HT receptor types. European Journal of Pharmacology 716(1-3):8-16.

  • Liu Q, Yao X, Gao S, Li R, Li B, Yang W, Cui R 2020. Role of 5-HT receptors in neuropathic pain: potential therapeutic implications. Pharmacological Research:104949.

  • Megumu Y, Hidemasa F 2006. Mechanisms for the anti-nociceptive actions of the descending noradrenergic and serotonergic systems in the spinal cord. Journal of Pharmacological Sciences 101(2):107-117.

  • Haleem DJ 2018. Serotonin-1A receptor dependent modulation of pain and reward for improving therapy of chronic pain. Pharmacological Research 134:212-219.

  • Maund E, Tendal B, Hróbjartsson A, Jørgensen KJ, Lundh A, Schroll J, Gøtzsche PC 2014. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications. Bmj 348.

  • Brunton S, Wang F, Edwards SB, Crucitti AS, Ossanna MJ, Walker DJ, Robinson MJ 2010. Profile of adverse events with duloxetine treatment. Drug safety 33(5):393-407.

  • Knadler MP, Lobo E, Chappell J, Bergstrom R 2011. Duloxetine. Clinical pharmacokinetics 50(5):281-294.

  • Li H, Li T, Li Y, Shen Y 2013. Pharmacokinetics and safety of duloxetine enteric-coated tablets in chinese healthy volunteers: a randomized, open-label, single-and multiple-dose study. Clinical Psychopharmacology and Neuroscience 11(1):28.

  • Das S, Halder P 2008. Formulation and evaluation of duloxetine hydrochloride (enteric coated) tablets. Asian Journal of Chemistry 20(6):4519.

  • Setia A, Kansal S, Goyal N 2013. Development and optimization of enteric coated mucoadhesive microspheres of duloxetine hydrochloride using 32 full factorial design. International Journal of Pharmaceutical Investigation 3(3):141.

  • Peddapalli H, Chinnala K, Banala N 2017. Design and in vitro characterization of mucoadhesive buccal patches of duloxetine hydrochloride. Int J Pharm Pharm Sci 9:52-59.

  • El Sharawy AM, Shukr MH, Elshafeey AH 2017. Formulation and optimization of duloxetine hydrochloride buccal films: in vitro and in vivo evaluation. Drug delivery 24(1):1762-1769.

  • Anishetty R, Singh SK, Garg V, Yadav AK, Gulati M, Kumar B, Pandey NK, Narang R 2016. Discriminatory potential of biphasic medium over compendial and biorelevant medium for assessment of dissolution behavior of tablets containing meloxicam nanoparticles (Only Abstract).

  • Kumar B, Garg V, Singh A, Pandey NK, Singh S, Panchal S, Melkani I, Raji R, Axel M, Mohanta S, Jyoti J, Som S, Gulati M, Bhatia A, T P, Singh SK 2018. Investigation and Optimization of Formulation Parameters FOR Selfnanoemulsifying Delivery system of two Lipophilic and Gastrointestinal Labile drugs using box-behnken design. 2018:7.

  • Kumar B, Garg V, Singh S, Pandey NK, Bhatia A, Prakash T, Gulati M, Singh SK 2018. Impact of spray drying over conventional surface adsorption technique for improvement in micromeritic and biopharmaceutical characteristics of self-nanoemulsifying powder loaded with two lipophilic as well as gastrointestinal labile drugs. Powder Technology 326:425-442.

  • Kumar B, Malik AH, Sharma P, Rathee H, Prakash T, Bhatia A, Gulati M, Pandey NK, Baghel SS, Singh SK 2017. Validated reversed-phase high-performance liquid chromatography method for simultaneous estimation of curcumin and duloxetine hydrochloride in tablet and self-nanoemulsifying drug delivery systems. Journal of Pharmacy Research| Vol 11(9):1166.

  • Kumar B, Singh SK, Prakash T, Bhatia A, Gulati M, Garg V, Pandey NK, Singh S, Melkani I 2020. Pharmacokinetic and pharmacodynamic evaluation of Solid self-nanoemulsifying delivery system (SSNEDDS) loaded with curcumin and duloxetine in attenuation of neuropathic pain in rats. Neurological Sciences:1-13.

  • Yasuda H, Hotta N, Kasuga M, Kashiwagi A, Kawamori R, Yamada T, Baba Y, Alev L, Nakajo K 2016. Efficacy and safety of 40 mg or 60 mg duloxetine in J apanese adults with diabetic neuropathic pain: Results from a randomized, 52‐week, open‐label study. Journal of Diabetes Investigation 7(1):100-108.

  • Salehifar E, Janbabaei G, Hendouei N, Alipour A, Tabrizi N, Avan R 2020. Comparison of the efficacy and safety of pregabalin and duloxetine in taxane-induced sensory neuropathy: A randomized controlled trial. Clinical drug Investigation 40(3):249-257.

  • Brannan SK, Mallinckrodt CH, Detke MJ, Watkin JG, Tollefson GD 2005. Onset of action for duloxetine 60 mg once daily: double-blind, placebo-controlled studies. Journal of Psychiatric Research 39(2):161-172.

  • Park SH, Wackernah RC, Stimmel GL 2014. Serotonin syndrome: is it a reason to avoid the use of tramadol with antidepressants? Journal of Pharmacy Practice 27(1):71-78.

  • Kramer K, Bennett J 2015. 3 Laboratory evaluation. Anesthesia complications in the dental office:15.

  • König K, Gätje R, Süß J, Scharl A, Bareiter T. 2006. Gynäkologische Praxis. Die Gynäkologie, ed.: Springer. p 715-732.

  • Yerramsett P 2012. Formulation, Development and Evaluation of delayed release capsules of Duloxetine Hydrochloride made of different Enteric Polymers. Int J Drug Dev & Res 4:117-129.

  • Peddapalli H, Chinnala KM, Banala N 2017. Design and in vitro characterization of mucoadhesive buccal patches of duloxetine hydrochloride. Int J Pharm Pharm Sci 9:52-59.

  • Kuang C, Sun Y, Li B, Fan R, Zhang J, Yao Y, He Z 2017. Preparation and evaluation of duloxetine hydrochloride enteric-coated pellets with different enteric polymers. Asian Journal of Pharmaceutical Sciences 12(3):216-226.

  • Sohail MF, Shahnaz G, ur Rehman F, ur Rehman A, Ullah N, Amin U, Khan GM, Shah KU 2019. Development and evaluation of optimized thiolated chitosan proniosomal gel containing duloxetine for intranasal delivery. AAPS Pharm Sci Tech 20(7):1-12.

  • Jyoti J, Anandhakrishnan NK, Singh SK, Kumar B, Gulati M, Gowthamarajan K, Kumar R, Yadav AK, Kapoor B, Pandey NK 2019. A three-pronged formulation approach to improve oral bioavailability and therapeutic efficacy of two lipophilic drugs with gastric lability. Drug Delivery and Translational Research 9(4):848-865.

  • Sindhu P, Kumar S, Iqbal B, Ali J, Baboota S 2018. Duloxetine loaded-microemulsion system to improve behavioral activities by upregulating serotonin and norepinephrine in brain for the treatment of depression. Journal of psychiatric research 99:83-95.

  • Chahal SK, Sodhi RK, Madan J 2020. Duloxetine hydrochloride loaded film forming dermal gel enriched with methylcobalamin and geranium oil attenuates paclitaxel-induced peripheral neuropathy in rats. IBRO reports 9:85-95.

  • Kumar B, Malik AH, Sharma P, Rathee H, Prakash T, Bhatia A, Gulati M, Pandey NK, Baghel SS, Singh SK 2017. Validated reversed-phase high-performance liquid chromatography method for simultaneous estimation of curcumin and duloxetine hydrochloride in tablet and self-nanoemulsifying drug delivery systems. J Pharm Res 11:1166.

  • Yuen E, Gueorguieva I, Bueno‐Burgos L, Iyengar S, Aarons L 2013. Population pharmacokinetic/pharmacodynamic models for duloxetine in the treatment of diabetic peripheral neuropathic pain. European Journal of Pain 17(3):382-393.

  • Gao Y, Guo X, Han P, Li Q, Yang G, Qu S, Yue L, Wang CN, Skljarevski V, Dueñas H 2015. Treatment of patients with diabetic peripheral neuropathic pain in China: a double‐blind randomised trial of duloxetine vs. placebo. International Journal of Clinical Practice 69(9):957-966.

  • Vranken J, Hollmann M, Van der Vegt M, Kruis M, Heesen M, Vos K, Pijl A, Dijkgraaf M 2011. Duloxetine in patients with central neuropathic pain caused by spinal cord injury or stroke: a randomized, double-blind, placebo-controlled trial. PAIN® 152(2):267-273.

  • Yang Y-H, Lin J-K, Chen W-S, Lin T-C, Yang S-H, Jiang J-K, Chang S-C, Lan Y-T, Lin C-C, Yen C-C 2012. Duloxetine improves oxaliplatin-induced neuropathy in patients with colorectal cancer: an open-label pilot study. Supportive Care in Cancer 20(7):1491-1497.

  • Vollmer TL, Robinson MJ, Risser RC, Malcolm SK 2014. A Randomized, Double‐Blind, Placebo‐Controlled Trial of Duloxetine for the Treatment of Pain in Patients with Multiple Sclerosis. Pain Practice 14(8):732-744.

  • Matsuoka H, Iwase S, Miyaji T, Kawaguchi T, Ariyoshi K, Oyamada S, Satomi E, Ishiki H, Hasuo H, Sakuma H 2020. Predictors of duloxetine response in patients with neuropathic cancer pain: a secondary analysis of a randomized controlled trial—JORTC-PAL08 (DIRECT) study. Supportive Care in Cancer 28(6):2931-2939.

  • Matsuoka H, Makimura C, Koyama A, Otsuka M, Okamoto W, Fujisaka Y, Kaneda H, Tsurutani J, Nakagawa K 2012. Pilot study of duloxetine for cancer patients with neuropathic pain non-responsive to pregabalin. Anticancer research 32(5):1805-1809.

  • Najafi A, Nejad HZ, Nikvarz N 2019. Evaluation of the analgesic effects of duloxetine in burn patients: An open-label randomized controlled trial. Burns 45(3):598-609.

  • Blikman T, Rienstra W, van Raaij T, ten Hagen A, Dijkstra B, Zijlstra W, Bulstra S, van den Akker-Scheek I, Stevens M 2016. Duloxetine in OsteoArthritis (DOA) study: study protocol of a pragmatic open-label randomised controlled trial assessing the effect of preoperative pain treatment on postoperative outcome after total hip or knee arthroplasty. BMJ open 6(3):e010343.

  • Enomoto H, Fujikoshi S, Tsuji T, Sasaki N, Tokuoka H, Uchio Y 2018. Efficacy of duloxetine by prior NSAID use in the treatment of chronic osteoarthritis knee pain: a post hoc subgroup analysis of a randomized, placebo-controlled, phase 3 study in Japan. Journal of Orthopaedic Science 23(6):1019-1026.

  • Yarnitsky D, Granot M, Nahman-Averbuch H, Khamaisi M, Granovsky Y 2012. Conditioned pain modulation predicts duloxetine efficacy in painful diabetic neuropathy. Pain 153(6):1193-1198.

  • Tanenberg RJ, Irving GA, Risser RC, Ahl J, Robinson MJ, Skljarevski V, Malcolm SK. Mayo Clinic Proceedings, 2011, pp 615-626.

  • Tanenberg RJ, Clemow DB, Giaconia JM, Risser RC 2014. Duloxetine compared with pregabalin for diabetic peripheral neuropathic pain management in patients with suboptimal pain response to gabapentin and treated with or without antidepressants: a post hoc analysis. Pain Practice 14(7):640-648.

  • Majdinasab N, Kaveyani H, Azizi M 2019. A comparative double-blind randomized study on the effectiveness of Duloxetine and Gabapentin on painful diabetic peripheral polyneuropathy. Drug design, Development and Therapy 13:1985.

  • Farshchian N, Alavi A, Heydarheydari S, Moradian N 2018. Comparative study of the effects of venlafaxine and duloxetine on chemotherapy-induced peripheral neuropathy. Cancer Chemotherapy and Pharmacology 82(5):787-793.

  • Matsuoka H, Ishiki H, Iwase S, Koyama A, Kawaguchi T, Kizawa Y, Morita T, Matsuda Y, Miyaji T, Ariyoshi K 2017. Study protocol for a multi-institutional, randomised, double-blinded, placebo-controlled phase III trial investigating additive efficacy of duloxetine for neuropathic cancer pain refractory to opioids and gabapentinoids: the DIRECT study. BMJ open 7(8).

  • Matsuoka H, Iwase S, Miyaji T, Kawaguchi T, Ariyoshi K, Oyamada S, Satomi E, Ishiki H, Hasuo H, Sakuma H 2019. Additive duloxetine for cancer-related neuropathic pain nonresponsive or intolerant to opioid-pregabalin therapy: a randomized controlled trial (JORTC-PAL08). Journal of Pain and Symptom Management 58(4):645-653.

  • Gül Şk, Tepetam H, Gül HL 2020. Duloxetine and pregabalin in neuropathic pain of lung cancer patients. Brain and Behavior 10(3):e01527.

  • Boyle J, Eriksson ME, Gribble L, Gouni R, Johnsen S, Coppini DV, Kerr D 2012. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life. Diabetes care 35(12):2451-2458.

  • Wernicke JF, Gahimer J, Yalcin I, Wulster-Radcliffe M, Viktrup L 2005. Safety and adverse event profile of duloxetine. Expert opinion on drug safety 4(6):987-993.

  • Ball SG, Desaiah D, Zhang Q, Thase ME, Perahia DG 2013. Efficacy and safety of duloxetine 60 mg once daily in major depressive disorder: a review with expert commentary. Drugs in context 2013.

  • Muscatello MRA, Zoccali RA, Pandolfo G, Mangano P, Lorusso S, Cedro C, Battaglia F, Spina E, Bruno A 2019. Duloxetine in psychiatric disorders: expansions beyond major depression and generalized anxiety disorder. Frontiers in Psychiatry 10:772.

  • Atkinson SD, Prakash A, Zhang Q, Pangallo BA, Bangs ME, Emslie GJ, March JS 2014. A double-blind efficacy and safety study of duloxetine flexible dosing in children and adolescents with major depressive disorder. Journal of child and adolescent psychopharmacology 24(4):180-189.

  • Kok RM, Reynolds CF 2017. Management of depression in older adults: A Review. Jama 317(20):2114-2122.

  • Thase ME, Tran PV, Wiltse C, Pangallo BA, Mallinckrodt C, Detke MJ 2005. Cardiovascular profile of duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine. Journal of Clinical Psychopharmacology 25(2):132-140.

  • Irving G, Tanenberg R, Raskin J, Risser R, Malcolm S 2014. Comparative safety and tolerability of duloxetine vs. pregabalin vs. duloxetine plus gabapentin in patients with diabetic peripheral neuropathic pain. International Journal of Clinical Practice 68(9):1130-1140.

  • Chappell AS, Desaiah D, Liu‐Seifert H, Zhang S, Skljarevski V, Belenkov Y, Brown JP 2011. A double‐blind, randomized, placebo‐controlled study of the efficacy and safety of duloxetine for the treatment of chronic pain due to osteoarthritis of the knee. Pain Practice 11(1):33-41.

  • Hardy T, Sachson R, Shen S, Armbruster M, Boulton AJ 2007. Does treatment with duloxetine for neuropathic pain impact glycemic control? Diabetes Care 30(1):21-26.

  • Härmark L, van Puijenbroek E, van Grootheest K 2013. Intensive monitoring of duloxetine: results of a web-based intensive monitoring study. European Journal of Clinical Pharmacology 69(2):209-215.

  • McIntyre RS, Panjwani ZD, Nguyen HT, Woldeyohannes HO, Alsuwaidan M, Soczynska JK, Lourenco MT, Konarski JZ, Kennedy SH 2008. The hepatic safety profile of duloxetine: a review. Expert opinion on drug Metabolism & Toxicology 4(3):281-285.


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  • Role of Duloxetine in Neuropathic Pain: A Clinical Impact, Mechanism, Challenges in Formulation Development to Safety Concern

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Authors

Linu Dash
School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab,, India
Bimlesh Kumar
School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab,, India
Anupriya
School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab,, India
Varimadugu Bhanukirankumar Reddy
School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab,, India
Indu Melkani
School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab,, India
Narendra Kumar Pandey
School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab,, India
Kardam Joshi
Topicals Research and Development, Amneal Pharmaceuticals, Piscataway, New Jersey,, United States
Dhara Patel
Topicals Research and Development, Amneal Pharmaceuticals, Piscataway, New Jersey,, United States

Abstract


Neuropathic pain (NP) is a dreadful disease of the somatosensory nervous system with many etiologies. The antidepressant drug is recommended as the first-line drug for the management of such pain. Duloxetine (DXH) is one of the classes of antidepressant drugs having an efficient use in mild to severe pain management. There are many clinical studies conducted on DXH and tested for its effectiveness in NP. For this review articles were collected from PubMed, Science Direct, goggle scholar, and other relevant sites. This review is based on the recently updated articles on duloxetine. The inclusion criteria for this was an English, clinical study with a year of publication between mostly 2010-2020, the DXH and its treatment of NP, comparison of DXH with another drug for the treatment of NP. The only exclusion criteria for this review is the preclinical study. The study design (randomized, cross-sectional, double-blinded), compound DXH regime, outcome measure of the study, and the efficacy were taken into consideration. The present review focused on the molecular targets, challenges, formulation development, comparison with some other drugs in terms of therapeutic benefits, and tolerance with the safety issue of DXH. It was found that DXH provides impactful relief from pain but still modification in the treatment strategies for NP is required.

Keywords


Depression, Neuropathic pain, Duloxetine, Clinical pattern.

References