A technology evaluation of CVT-301 (Inbrija): an inhalable therapy for treatment of Parkinson’s disease

References

• LeWitt PA. Levodopa for the treatment of Parkinson’s disease. N Engl J Med. 2008 Dec 4;359(23):2468–2476.
   PubMed Web of Science ®Google Scholar
• LeWitt PA. Levodopa therapy for Parkinson’s disease: pharmacokinetics and pharmacodynamics. Mov Disord. 2015 Jan;30(1):64–72.
   PubMed Web of Science ®Google Scholar
• Fasano A, Visanji NP, Liu LW, et al. Gastrointestinal dysfunction in Parkinson’s disease. Lancet Neurol. 2015 Jun;14(6):625–639.
   PubMed Web of Science ®Google Scholar
• Pfeiffer RF, Isaacson SH, Pahwa R. Clinical implications of gastric complications on levodopa treatment in Parkinson’s disease. Parkinsonism Relat Disord. 2020 Jul;11(76):63–71.
   Google Scholar
• Heetun ZS, Quigley EM. Gastroparesis and Parkinson’s disease: a systematic review. Parkinsonism Relat Disord. 2012 Jun;18(5):433–440.
   PubMed Web of Science ®Google Scholar
• Levein NG, Thorn SE, Wattwil M. Dopamine delays gastric emptying and prolongs orocaecal transit time in volunteers. Eur J Anaesthesiol. 1999 Apr;16(4):246–250.
   PubMed Web of Science ®Google Scholar
• Robertson DR, Renwick AG, Wood ND, et al. The influence of levodopa on gastric emptying in man. Br J Clin Pharmacol. 1990 Jan;29(1):47–53.
   PubMed Web of Science ®Google Scholar
• Nyholm D, Lennernas H. Irregular gastrointestinal drug absorption in Parkinson’s disease. Expert Opin Drug Metab Toxicol. 2008 Feb;4(2):193–203.
   PubMed Web of Science ®Google Scholar
• McGee DJ, Lu XH, Disbrow EA. Stomaching the possibility of a pathogenic role for Helicobacter pylori in Parkinson’s disease. J Parkinsons Dis. 2018;8(3):367–374.
   PubMedGoogle Scholar
• Narozanska E, Bialecka M, Adamiak-Giera U, et al. Pharmacokinetics of levodopa in patients with Parkinson disease and motor fluctuations depending on the presence of Helicobacter pylori infection. Clin Neuropharmacol. 2014 Jul-Aug;37(4):96–99.
   PubMed Web of Science ®Google Scholar
• Virmani T, Tazan S, Mazzoni P, et al. Motor fluctuations due to interaction between dietary protein and levodopa in Parkinson’s disease. J Clin Mov Disord. 2016;3:8.
   PubMedGoogle Scholar
• LeWitt PA, Hauser RA, Grosset DG, et al. A randomized trial of inhaled levodopa (CVT-301) for motor fluctuations in Parkinson’s disease. Mov Disord. 2016 Sep;31(9):1356–1365.
   PubMed Web of Science ®Google Scholar
• LeWitt PA, Hauser RA, Pahwa R, et al. Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson’s disease: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. 2019 Feb;18(2):145–154.
   PubMed Web of Science ®Google Scholar
• Newman SP. Drug delivery to the lungs: challenges and opportunities. Ther Deliv. 2017 Jul;8(8):647–661.
   PubMed Web of Science ®Google Scholar
• Roche N, Dekhuijzen PN. The evolution of pressurized metered-dose inhalers from early to modern devices. J Aerosol Med Pulm Drug Deliv. 2016 Aug;29(4):311–327.
   PubMed Web of Science ®Google Scholar
• Stein SW, Thiel CG. The history of therapeutic aerosols: a chronological review. J Aerosol Med Pulm Drug Deliv. 2017 Feb;30(1):20–41.
   PubMed Web of Science ®Google Scholar
• The Montreal protocol on substances that deplete the ozone layer, Final Act (Nairobi: UNEP 1987). Federal Register. 1994 (59 FR 56276–56298).
   Google Scholar
• De Boer AH, Hagedoorn P, Hoppentocht M, et al. Dry powder inhalation: past, present and future. Expert Opin Drug Deliv. 2017 Apr;14(4):499–512.
   PubMed Web of Science ®Google Scholar
• Lavorini F, Pistolesi M, Usmani OS. Recent advances in capsule-based dry powder inhaler technology. Multidiscip Respir Med. 2017;12:11.
   PubMed Web of Science ®Google Scholar
• Lin YW, Wong J, Qu L, et al. Powder production and particle engineering for dry powder inhaler formulations. Curr Pharm Des. 2015;21(27):3902–3916.
   PubMed Web of Science ®Google Scholar
• Sibum I, Hagedoorn P, De Boer AH, et al. Challenges for pulmonary delivery of high powder doses. Int J Pharm. 2018 Sep 5;548(1):325–336.
   PubMedGoogle Scholar
• Telko MJ, Hickey AJ. Dry powder inhaler formulation. Respir Care. 2005 Sep;50(9):1209–1227.
   PubMedGoogle Scholar
• Edwards DA, Hanes J, Caponetti G, et al. Large porous particles for pulmonary drug delivery. Science. 1997 Jun 20;276(5320):1868–1871.
   PubMed Web of Science ®Google Scholar
• Aitken ML, Bellon G, De Boeck K, et al. Long-term inhaled dry powder mannitol in cystic fibrosis: an international randomized study. Am J Respir Crit Care Med. 2012 Mar 15;185(6):645–652.
   PubMed Web of Science ®Google Scholar
• Bilton D, Robinson P, Cooper P, et al. Inhaled dry powder mannitol in cystic fibrosis: an efficacy and safety study. Eur Respir J. 2011 Nov;38(5):1071–1080.
   PubMed Web of Science ®Google Scholar
• Tappenden P, Harnan S, Uttley L, et al. Colistimethate sodium powder and tobramycin powder for inhalation for the treatment of chronic Pseudomonas aeruginosa lung infection in cystic fibrosis: systematic review and economic model. Health Technol Assess. 2013 Dec;17(56):v–xvii, 1–181.
   Web of Science ®Google Scholar
• Uttley L, Harnan S, Cantrell A, et al. Systematic review of the dry powder inhalers colistimethate sodium and tobramycin in cystic fibrosis. Eur Respir Rev. 2013 Dec;22(130):476–486.
   PubMedGoogle Scholar
• Geller DE, Weers J, Heuerding S. Development of an inhaled dry-powder formulation of tobramycin using PulmoSphere technology. J Aerosol Med Pulm Drug Deliv. 2011 Aug;24(4):175–182.
   PubMed Web of Science ®Google Scholar
• Hickey AJ. Back to the future: inhaled drug products. J Pharm Sci. 2013 Apr;102(4):1165–1172.
   PubMed Web of Science ®Google Scholar
• Healy AM, Amaro MI, Paluch KJ, et al. Dry powders for oral inhalation free of lactose carrier particles. Adv Drug Deliv Rev. 2014 Aug;75:32–52.
   PubMed Web of Science ®Google Scholar
• Bartus RT, Emerich D, Snodgrass-Belt P, et al. A pulmonary formulation of L-dopa enhances its effectiveness in a rat model of Parkinson’s disease. J Pharmacol Exp Ther. 2004 Aug;310(2):828–835.
   PubMed Web of Science ®Google Scholar
• Lipp MM, Batycky R, Moore J, et al. Preclinical and clinical assessment of inhaled levodopa for OFF episodes in Parkinson’s disease. Sci Transl Med. 2016 Oct 12;8(360):360ra136.
   PubMed Web of Science ®Google Scholar
• Notter RH, Finkelstein JN. Pulmonary surfactant: an interdisciplinary approach. J Appl Physiol Respir Environ Exerc Physiol. 1984 Dec;57(6):1613–1624.
   PubMed Web of Science ®Google Scholar
• Willson DF, Notter RH. The future of exogenous surfactant therapy. Respir Care. 2011 Sep;56(9):1369–1386. discussion1386–1388.
   PubMed Web of Science ®Google Scholar
• Goetz CG, Tilley BC, Shaftman SR, et al. Movement Disorder Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129–2170.
   PubMed Web of Science ®Google Scholar
• Safirstein BE, Ellenbogen A, Zhao P, et al. Pharmacokinetics of inhaled levodopa administered with oral carbidopa in the fed state in patients with Parkinson’s disease. Clin Ther. 2020 May 29;42(6):1034–1046.
   PubMed Web of Science ®Google Scholar
• Grosset DG, Dhall R, Gurevich T, et al. Inhaled levodopa in Parkinson’s disease patients with OFF periods: a randomized 12-month pulmonary safety study. Parkinsonism Relat Disord. 2019 Dec 23;71:4–10.
   PubMed Web of Science ®Google Scholar
• Farbman ES, Waters CH, LeWitt PA, et al. A 12-month, dose-level blinded safety and efficacy study of levodopa inhalation powder (CVT-301, Inbrija) in patients with Parkinson’s disease. Parkinsonism Relat Disord. 2020 Oct 17;81:144–150.
   PubMed Web of Science ®Google Scholar
• Hauser RA, Isaacson SH, Ellenbogen A, et al. Orally inhaled levodopa (CVT-301) for early morning OFF periods in Parkinson’s disease. Parkinsonism Relat Disord. 2019 Jul;64:175–180.
   PubMed Web of Science ®Google Scholar
• Ibrahim M, Verma R, Garcia-Contreras L. Inhalation drug delivery devices: technology update. Med Devices (Auckl). 2015;8:131–139.
   PubMedGoogle Scholar
• Martinez-Fernandez R, Schmitt E, Martinez-Martin P, et al. The hidden sister of motor fluctuations in Parkinson’s disease: a review on nonmotor fluctuations. Mov Disord. 2016 Aug;31(8):1080–1094.
   PubMed Web of Science ®Google Scholar
• Olanow CW, Stocchi F. Levodopa: SF. A new look at an old friend. Mov Disord. 2018 Jul;33(6):859–866.
   PubMed Web of Science ®Google Scholar
• Chou KL, Stacy M, Simuni T, et al. The spectrum of “off” in Parkinson’s disease: what have we learned over 40 years? Parkinsonism Relat Disord. 2018 Jun;51:9–16.
   Google Scholar
• LeWitt PA, Chaudhuri KR. Unmet needs in Parkinson disease: motor and non-motor. Parkinsonism Relat Disord. 2020 Nov;80(Suppl 1):S7–S12.
   PubMed Web of Science ®Google Scholar
• Matthews H, Stamford J, Saha R, et al. Exploring issues around wearing-off and quality of life: the OFF-PARK survey of people with Parkinson’s disease and their care partners. J Parkinsons Dis. 2015;5(3):533–539.
   PubMedGoogle Scholar
• Chapuis S, Ouchchane L, Metz O, et al. Impact of the motor complications of Parkinson’s disease on the quality of life. Mov Disord. 2005 Feb;20(2):224–230.
   PubMed Web of Science ®Google Scholar
• Stacy M, Bowron A, Guttman M, et al. Identification of motor and nonmotor wearing-off in Parkinson’s disease: comparison of a patient questionnaire versus a clinician assessment. Mov Disord. 2005 Jun;20(6):726–733.
   PubMed Web of Science ®Google Scholar
• Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014 Apr 23-30;311(16):1670–1683.
   PubMed Web of Science ®Google Scholar
• Moore H, Shpiner DS, Luca CC. Management of motor features in advanced Parkinson disease. Clin Geriatr Med. 2020 Feb;36(1):43–52.
   PubMed Web of Science ®Google Scholar
• Moldovan AS, Groiss SJ, Elben S, et al. The treatment of Parkinson’s disease with deep brain stimulation: current issues. Neural Regen Res. 2015 Jul;10(7):1018–1022.
   PubMed Web of Science ®Google Scholar
• Bronstein JM, Tagliati M, Alterman RL, et al. Deep brain stimulation for Parkinson disease: an expert consensus and review of key issues. Arch Neurol. 2011 Feb;68(2):165.
   PubMed Web of Science ®Google Scholar
• Pfeiffer RF. Gastrointestinal dysfunction in Parkinson’s disease. Curr Treat Options Neurol. 2018 Oct 25;20(12):54.
   PubMed Web of Science ®Google Scholar
• Nutt JG, Woodward WR, Hammerstad JP, et al. The “on-off” phenomenon in Parkinson’s disease. Relation to levodopa absorption and transport. N Engl J Med. 1984 Feb 23;310(8):483–488.
   PubMed Web of Science ®Google Scholar
• Isaacson S, Lew M, Ondo W, et al. Apomorphine subcutaneous injection for the management of morning akinesia in Parkinson’s disease. Mov Disord Clin Pract. 2017 Jan-Feb;4(1):78–83.
   PubMed Web of Science ®Google Scholar
• Hauser RA, Olanow CW, Dzyngel B, et al. Sublingual apomorphine (APL-130277) for the acute conversion of OFF to ON in Parkinson’s disease. Mov Disord. 2016 Sep;31(9):1366–1372.
   PubMed Web of Science ®Google Scholar