Alexza Pharmaceuticals has retained Lazard to assist in exploring strategic options to enhance stockholder value, including a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions.
In order to conserve cash to support operations, Alexza has provided to all of its employees a 60-day notice of layoffs under the California WARN Act. Alexza expects to significantly reduce its work force as it continues the actions necessary to pursue FDA approval of ADASUVE and continues its Marketing Authorization Application work with the European Medicines Agency.
The Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA voted to recommend that ADASUVE (Staccato loxapine) be approved for use as a single dose in 24 hours in conjunction with the FDA recommended Risk Evaluation and Mitigation Strategy (REMS), for the treatment of agitation in patients with schizophrenia or bipolar mania.
The PDAC also concluded that the product had been shown to be effective and that the product would be acceptably safe for use as a single dose in 24 hours, when used in conjunction with the REMS proposed by the FDA.