Alexza Pharmaceuticals says that it has resubmitted its NDA for Adasuve inhaled loxapine for the treatment of agitation in patients with bipolar disorder or schizophrenia; the company received a Complete Response Letter for the Adasuve NDA in May 2012. The company says that it expects a response from the FDA as to how the resubmission will be classified and the new Prescription Drug User Fee Act (PDUFA) goal date.
The company also updated the status of its MAA for Adasuve in Europe. The Committee for Medicinal Products for Human Use issued a Day 120 List of Questions regarding the MAA in March 2012, including concerns about use of Phase 3 clinical efficiency data and the manufacturing process. After meetings between the company and its partner Grupo Ferrer with regulators in May 2012, Alexza says, it “believes it remains on schedule for the targeted early third quarter of 2012 submission of its responses (Day 121 Submission) to the EMA.”
Read the Alexza press release.
