The US FDA has announced a December 12 meeting of the Psychopharmacologic Drugs Advisory Committee to discuss safety concerns related to Alexza’s Adasuve loxapine inhalation powder for the treatment of agitation associated with schizophrenia or bipolar disorder. Alexza resubmitted an NDA for the product in August 2011. The company first submitted the NDA in December 2009 and received a complete response letter in October 2010 that questioned Adasuve’s safety.
According to the briefing materials, the Division of Psychiatry Products accepts the efficacy of the product but still has safety concerns, explaining: “The primary issue that still needs resolution is the concern about a potential for pulmonary toxicity with this product in certain vulnerable populations. The sponsor has proposed a REMS to address this concern, however, FDA remains concerned about the adequacy of this program to allow for the safe use of this product.”
One of the questions slated for discussion during the meeting is: “Adasuve clearly can cause bronchospasm, a particular concern for patients with asthma. There is uncertainty as to whether agitated patients can be properly assessed for an asthma history. Do you think the sponsor’s proposed Risk Evaluation and Mitigation Strategy (REMS) would ensure that the benefits of Adasuve outweigh its risks?”
View the meeting materials.
