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Alexza employees face the chop in company bid to prop up Adasuve development

Drug Delivery Insight

In an effort to save cash in the current economic downturn, Alexza Pharmaceuticals has made the difficult decision to appoint a financial advisor to assist in exploring strategic options for the company. These options could include a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions. In order to conserve cash needed to support operations, Alexza has provided to all of its employees a 60-day notice of layoffs under the California WARN Act. The company expects to significantly reduce its workforce as it continues the actions necessary to pursue FDA approval of Adasuve (Staccato loxapine) and continues its MAA work with the EMA.

Recently, the Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA voted to recommend that Adasuve be approved for use as a single dose in 24 hours in conjunction with the FDA recommended REMS, for the treatment of agitation in patients with schizophrenia or bipolar mania. The vote on this question was 9/8/1 (yes/no/abstain). The PDAC also concluded that the product had been shown to be effective (vote of 17/1/0; yes/no/abstain), 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 (vote of 11/5/2; yes/no/abstain). The Adasuve NDA has a PDUFA goal date of 4th February 2012.

Adasuve is an anti-agitation product candidate that combines Alexza’s Staccato system with loxapine, an antipsychotic currently available in the US as an oral formulation for the management of schizophrenia. The Staccato system is a hand-held, single-dose inhaler that delivers a medication comparable with intravenous administration. In clinical studies, Adasuve has shown an onset of effect in ten minutes of dosing, which is the first time point measured in Phase III studies.

Article source; Kindly provided by Sophie Bracken, editor of Espicom’s business publication Drug Delivery Insight




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