NDA for loxapine as a treatment for agitation in patients with schizophrenia or bipolar disorder is currently under review.

Biovail is paying Alexza Pharmaceuticals $40 million up front as part of a North American development and commercialization deal for the latter’s therapy for agitation in patients with schizophrenia or bipolar disorder. AZ-004, an inhaled loxapine administered using Alexza’s Staccato® device, was submitted to the FDA for regulatory review in December 2009.

Alexza could receive another $90 million in potential milestones relating to approval of the first AZ-004 NDA, commercial manufacturing scale-up, and development and approval of the drug in an outpatient setting in the same indications. The deal also covers the potential evelopment and commercialization of AZ-004 for multiple psychiatric and/or neurological indications and their symptoms.

In the meantime, Alexza will continue to manage the ongoing AZ-004 NDA review and approval process and will supply the drug to Biovail. Alexza is also developing Staccato loxapine for the treatment of migraine. Phase IIa and Phase IIb trials have already been completed.

Loxapine is currently available in the U.S. as an oral formulation to treat symptoms of schizophrenia. Alexza’s Staccato deep-lung inhalation device is designed to facilitate more rapid absorption of the drug through the lungs into the blood stream to allow faster therapeutic activity.

The company claims that the key to the technology is vaporization of drug without thermal degradation. This is achieved by heating a thin film of the drug so rapidly that thermal decomposition is minimal. After vaporization the drug cools rapidly in air, condensing into pure drug aerosol particles of near ambient temperature. On inhalation the particles are rapidly absorbed through the lungs into the bloodstream.

The Staccato system is breath-actuated, and a patient inhales to administer the drug dose. A special valve in the inhaler airway controls airflow over the vaporizing drug to achieve appropriate aerosol particle size.

Alexza is developing a pipeline of Staccato-delivered drugs including prochlorperazine for migraines and alprazolam for acute pain attachs, which are both in Phase II trials, along with fentanyl for breakthrough pain and zaleplon for insomnia, which have completed Phase I development. 

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