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Technosphere® Insulin

An Inhaled Prandial Insulin Product

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Abstract

Given the important role of insulin in the treatment of diabetes mellitus and in light of common barriers to insulin use, new strategies for insulin delivery by routes other than intravenous and subcutaneous injection have been investigated since the discovery of insulin in the 1920s. Most companies researching and developing pulmonary administration systems for the use of insulin announced the termination of product development following the failure of the first US FDA-approved inhaled insulin product, Exubera®. One company in particular continued their pursuit of a useful inhaled insulin product. MannKind Corporation has developed a powder formulation of insulin that allows for a high percentage of the administered insulin to be absorbed via the lung. Their product, AFREZZA™ (Technosphere® insulin), is currently under review by the FDA for use in patients with diabetes. Technosphere® insulin appears to overcome some of the barriers that contributed to the market withdrawal of Exubera® by the manufacturer. Studies with Technosphere® insulin have shown it to be a unique insulin formulation in that it is very rapid acting, has a relatively short duration of action, and is efficacious in terms of improved glycemic control without contributing to increased weight gain or the incidence of hypoglycemia when compared with other prandial insulin products. Additionally, Technosphere® insulin has demonstrated a favorable safety and tolerability profile in clinical studies to date.

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References

  1. Korytkowski M. When oral agents fail: practical barriers to starting insulin. Int J Obes Relat Metab Disord 2002; 26Suppl. 3: S18–24

    Article  PubMed  CAS  Google Scholar 

  2. Heinemann L, Pfutzner A, Heise T. Alternative routes of administration as an approach to improve insulin therapy: update on dermal, oral, nasal, and pulmonary insulin delivery. Curr Pharm Des 2001; 7: 1327–51

    Article  PubMed  CAS  Google Scholar 

  3. Siekmeier R, Scheuch G. Inhaled insulin: does it become reality? J Physiol Pharmacol 2008; 59Suppl. 6: 81–113

    PubMed  Google Scholar 

  4. Cefalu WT. Concept, strategies, and feasibility of non-invasive insulin delivery. Diabetes Care 2004; 27: 239–46

    Article  PubMed  Google Scholar 

  5. Setter SM, Levien TL, Iltz JL, et al. Inhaled dry powder insulin for the treatment of diabetes mellitus. Clin Ther 2007; 29: 795–813

    Article  PubMed  CAS  Google Scholar 

  6. Kling J. Inhaled insulin's last gasp? Nat Biotechnol 2008; 26: 479–80

    Article  PubMed  CAS  Google Scholar 

  7. Heinemann L. The failure of Exubera: are we beating a dead horse? J Diabetes Sci Technol 2008; 2: 518–29

    PubMed  Google Scholar 

  8. Amin N, Boss A, Richardson P. Long-term sustained safety and efficacy of continued use of technosphere insulin in subjects with type 2 diabetes [abstract no. OP215]. Diabetologia 2009; 52Suppl. 1: S94

    Google Scholar 

  9. Angelo R, Rousseau K, Grant M, et al. Technosphere® insulin: defining the mechanism of action [abstract no. 428-P]. Diabetes Care 2008; 57Suppl. 1: A128

    Google Scholar 

  10. Pfutzner A, Mann AE, Steiner SS. Technosphere/insulin: a new approach for effective delivery of human insulin via the pulmonary route. Diabetes Technol Ther 2002; 4: 589–94

    Article  PubMed  Google Scholar 

  11. Pfutzner A, Forst T. Pulmonary insulin delivery by means of the Technosphere™ drug carrier mechanism. Expert Opin Drug Deliv 2005; 2: 1097–106

    Article  PubMed  Google Scholar 

  12. Steiner S, Pfutzner A, Wilson BR, et al. Technosphere/insulin-proof of concept study with a new insulin formulation for pulmonary delivery. Exp Clin Endocrinol Diabetes 2002; 110: 17–21

    Article  PubMed  CAS  Google Scholar 

  13. Pfutzner A, Flacke F, Pohl R, et al. Pilot study with technosphere/PTH(1–34): a new approach for effective pulmonary delivery of parathyroid hormone (1–34). Horm Metab Res 2003; 35: 319–23

    Article  PubMed  CAS  Google Scholar 

  14. Lian H, Steiner SS, Sofia RD, et al. A self-complementary, self-assembling microsphere system: application for intravenous delivery of the antiepileptic and neuroprotectant compound felbamate. J Pharm Sci 2000; 89: 867–75

    Article  PubMed  CAS  Google Scholar 

  15. Potocka E, Hovorka R, Baughman R et al. Technosphere insulin suppresses endogenous glucose production earlier than a rapid-acting analogue (lispro) and an inhaled insulin (Exubera) [abstract no. 952]. Diabetologia 2009; 52Suppl. 1: S374

    Google Scholar 

  16. Rave K, Potocka E, Boss AH, et al. Pharmacokinetics and linear exposure of AFRESA™ compared with the subcutaneous injection of regular human insulin. Diabetes Obes Metab 2009; 11: 715–20

    Article  PubMed  CAS  Google Scholar 

  17. Cassidy JP, Marino MT, Amin N, et al. Lung deposition and absorption of insulin from AFRESA™ (Technosphere® insulin) [abstract no. 433-P]. Diabetes Care 2009; 58Suppl. 1: A115

    Google Scholar 

  18. Gotfried M, Cassidy J, Marino M, et al. Lung deposition and absorption of insulin from technosphere insulin [abstract no. 955]. Diabetologia 2009; 52Suppl. 1: S375

    Google Scholar 

  19. Cassidy JP, Baughman RA, Schwartz SL, et al. AFRESA™ (Technosphere® insulin) dosage strengths are interchangeable [abstract no. 425-P]. Diabetes Care 2009; 58Suppl. 1: A112–3

    Google Scholar 

  20. Richardson P, Potocka E, Baughman R, et al. Pharmacokinetics of technosphere insulin unchanged in patients with chronic obstructive pulmonary disease [abstract no. 954]. Diabetologia 2009; 52Suppl. 1: S375

    Google Scholar 

  21. Baughman R, Cassidy J, Levy B, et al. Technosphere® insulin (TI) pharmacokinetics unchanged in subjects who smoke [abstract no. 427-P]. Diabetes Care 2008; 57Suppl. 1: A128

    Google Scholar 

  22. Rave K, Heise T, Pfutzner A, et al. Coverage of postprandial blood glucose excursions with inhaled technosphere insulin in comparison to sub-cutaneously injected regular human insulin in subjects with type 2 diabetes. Diabetes Care 2007; 30: 2307–8

    Article  PubMed  CAS  Google Scholar 

  23. Rave K, Heise T, Heinemann L, et al. Inhaled Technosphere® insulin in comparison to subcutaneous regular human insulin: time action profile and variability in subjects with type 2 diabetes. J Diabets Sci Technol 2008; 2: 205–12

    Google Scholar 

  24. Tack CJ, Christov V, de Galan BE, et al. Randomized forced titration to different doses of Technosphere® insulin demonstrates reduction in postprandial glucose excursions and hemoglobin A1c in patients with type 2 diabetes. J Diabets Sci Technol 2008; 2: 47–57

    Google Scholar 

  25. Rosenstock J, Bergenstal R, DeFronzo RA, et al. Efficacy and safety of technosphere inhaled insulin compared with technosphere powder placebo in insulin-naïve type 2 diabetes suboptimally controlled with oral agents. Diabetes Care 2008; 31: 2177–82

    Article  PubMed  CAS  Google Scholar 

  26. Rosenstock J, Lorber DL, Petrucci RE, et al. Basal/bolus with prandial inhaled Technosphere® insulin (TI) plus insulin glargine QD vs biaspart 70/30 insulin BID in T2DM inadequately controlled on insulin with/without oral agents [abstract no. 466-P]. Diabetes Care 2009; 58Suppl. 1: A124

    Google Scholar 

  27. Rubin RR, Peyrot M. Patient reported outcomes in adults with type 1 diabetes using mealtime AFRESA™ (inhaled Technosphere® insulin) or rapid-acting insulin with basal insulin [abstract no. 1881-P]. Diabetes Care 2009; 58Suppl. 1: A484

    Google Scholar 

  28. Howard CP, Rubin RR, Peyrot M. Patient reported outcomes in adults with type 2 diabetes using mealtime AFRESA™ (inhaled Technosphere® insulin) and basal insulin versus premixed insulin [abstract no. 551-P]. Diabetes Care 2009; 58Suppl. 1: A148

    Google Scholar 

  29. Peyrot M, Rubin RR. Patient reported outcomes in adults with type 2 diabetes using mealtime AFRESA™ (inhaled Technosphere® insulin) or metformin+secretagogue or both [abstract no. 552-P]. Diabetes Care 2009; 5Suppl. 1: A148

    Google Scholar 

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Acknowledgments

No sources of funding were used to assist in the preparation of this review. The authors have no conflicts of interest that are directly relevant to the content of this review.

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Correspondence to Joshua J. Neumiller.

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Neumiller, J.J., Campbell, R.K. Technosphere® Insulin. BioDrugs 24, 165–172 (2010). https://doi.org/10.2165/11536700-000000000-00000

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