Inhaled Proteins and Peptides
Inhaled proteins and peptides have undergone a great deal of study in the last two decades. However, at present, there is only one approved inhaled protein, Pulmozyme (DNase), for the treatment of cystic fibrosis. Exubera (inhaled insulin) was approved but was withdrawn from the market primarily due to a lack of commercial success, not due to a lack of efficacy. Pulmozyme is an example of using inhalation for local lung treatment, while Exubera is an example of using lung delivery for systemic administration. A number of nonclinical and clinical studies for either local treatment or systemic delivery have shown varying degrees of success for a range of proteins and peptides. Summary information is provided for inhalation programs with DNase, insulin, growth hormone, cyclosporine, alpha-1-antitrypsin (AAT), anti-IgE, and vaccines. Examination of the features of these various programs provides insights for future activities. This chapter will provide high-level information related to inhaled proteins and peptides. More details are available in recent review papers [1-6].