Alexza Pharmaceuticals Inc (NASDAQ:ALXA)

CAPS Rating: 2 out of 5

An emerging pharmaceutical company focused on the development and commercialization of novel, proprietary products for the treatment of acute and intermittent conditions.

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Player Avatar mdriver78 (62.13) Submitted: 12/22/2012 10:43:16 PM : Underperform Start Price: $6.33 ALXA Score: +30.91

The spike will decay from the announcement that the FDA approved ADASUVE (loxapine) Inhalation Powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. ADASUVE combines Alexza's proprietary Staccato delivery system with the antipsychotic drug, loxapine. The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung that results in rapid systemic delivery and absorption of a drug. Management projects that ADASUVE will be available for commerical launch early in the third quarter of 2013. As part of the ADASUVE development program, Alexza identified a risk of bronchospasm in certain asthma and chronic obstructive pulmonary disease (COPD) patients following dosing with ADASUVE. It is important to note that ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. ADASUVE will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE REMS.

The REMS fears will likely way on the share price in the near term.

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