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Alexza failed to address salient long-term safety concerns

Although inhalable drugs have been quite effective in treating respiratory diseases such as asthma, inhaler therapy designed for non-pulmonary diseases has, thus far, performed poorly. For example, Pfizer (PFE) and Nektar Therapeutics's (NKTR) inhalable insulin drug Exubera was approved in 2006 and was expected to revolutionize diabetes care. However, it was pulled from the market the following year. Soon after Exubera was introduced to the market, concerns surfaced about potential negative effects of the drug on the lungs. One study found a reduction in lung function caused by the drug. Additional concern emerged during a post-marketing study where patients treated with Exubera developed lung cancer. Recently, MannKind Corporation (MNKD) has had difficulty getting its inhalable insulin therapy Afrezza approved. Therefore, it is notable that clinical studies for Adasuve were conducted on a short-term basis without an extended follow-up study. It is uncertain what long-term effects Adasuve may have on patients. Agitation medication is not taken on a regular, daily basis, which marginally reduces this concern. However, existing treatment options for agitation do not carry this long-term unknown, so the FDA is likely to be especially cautious with its upcoming decision regarding Adasuve.

http://seekingalpha.com/article/1058161-alexza-s-adasuve-may-not-be-ready-for-fda-approval