FDA Advisory committee recommends Adasuve (Aexza Pharma)l for agitation with Sschizophrenia

The FDA Psychopharmacologic Advisory Committee voted 9-8 to recommend Adasuve (inhaled loxapine) from Alexza Pharma, to treat agitation associated with schizophrenia or bipolar disorder. There was no problem with efficacy and an attraction in having a fast acting medication for agitated patients compared to needle administration with Abilify, Zyprexa or Geodon. However there have been no direct comparison studies of any of these drugs and Adasuve to determine which is faster acting. There will be a REMS programme associated with any approval. Concern was expressed by the committee about pulmonary toxicity especally in patients with pre-existing asthma or COPD.These epatients should not be treated with Adasuve but there remain questions of how to enforce the restriction in an emergency ssetting. The FDA will review the application and recommendation on 2 Februarey 2012.