We have not been impressed with clinical trial data generated by the AERx system, Novo’s NN1998, or other inhaled insulin formulations. The lead inhaled insulin system features Exubera from Nektar (NASDAQ: NKTR), Pfizer (NYSE: PFE), and Aventis (NYSE: AVE). Exubera and NN1998 both have a significantly lower that average probability of timely clinical trial success and timely regulatory review compared to other drugs in late-phase trials.

In the current investigation, published in this month’s issue of Diabetes Care, researchers randomized 107 patients to AERx or subcutaneous insulin. The AERx arm received fast-acting human insulin immediately before meals, whereas the subcutaneous group injected insulin 30 minutes before meals. Both arms received subcutaneous NPH insulin at bedtime. The incidence of adverse events was similar for both arms, and major safety problems were not observed in this short program. The overall data set for all inhaled insulin programs suggests the need for considerable investigational protocol refinements and longer-term evaluation of benefit:risk.

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