UPDATED: Alexza finally gets Adasuve agitation approval

Alexza Pharmaceuticals' ($ALXA) Adasuve, the company's inhaled form of the antipsychotic loxapine, has finally been approved in the U.S. for rapid treatment of the agitation seen in schizophrenia and bipolar disorder, and could be available by the third quarter of 2013.

Adasuve uses Alexza's Staccato delivery system, which delivers the drug deep into the lungs, where it can be carried quickly through the body. This frees up patients (and their caregivers) from injections, particularly key when patients have become distressed and agitated. The Staccato system works by heating and vaporizing a film of the drug, creating a drug aerosol that can be inhaled. The absorption is fast, and so the onset of effect is rapid, which is vital for acute and emergency treatment. The system has potential for single- or multiple-dose delivery.

In May, the FDA squashed Alexza's application for approval of Adasuve because of manufacturing deficiencies related to the device and Alexza lost a third of its share value. The approval comes just in time: In March, Alexza revealed that it was getting low in cash and was at risk of running out of money by the end of this year, even after firing almost 40% of its workforce. Adasuve could be worth $207 million in U.S. sales in 2016, a Roth Capital Partners analyst told Bloomberg.

Adasuve's approval still isn't quite straightforward. There is a risk of bronchospasm in patients who also have asthma and chronic obstructive pulmonary disease (COPD), leading to distress and even potentially fatal respiratory arrest. Because of this, the product is only available under a Risk Evaluation and Mitigation Strategy (REMS) program. It is also not approved in elderly patients with dementia-related psychosis treated with antipsychotic drugs, who are at an increased risk of death.

Earlier this month, European regulators delivered a positive opinion for Adasuve in the EU, for the rapid control of mild-to-moderate agitation in schizophrenia and bipolar disorder in a hospital setting. Alexza expects to get a decision in the first quarter, and the product is partnered with Ferrer in Europe, Latin America, Russia and the Commonwealth of Independent States.

- read the press release about the FDA approval
- see the press release about the European approval
- check out the article in Bloomberg

Editor's note: Additional information on the delivery system added.