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FDA panel backs Alexza’s inhaled antipsychotic drug

Narrow recommendation for Adasuve after re-filed marketing application

An inhaled formulation of an antipsychotic medication, developed by Alexza Pharmaceuticals, has been narrowly endorsed by a US Food and Drug Administration (FDA) advisory committee in the US.

Shares in Alexza climbed more than 70 per cent after the 9-8 vote by the Psychopharmacologic Drugs Advisory Committee (PDAC) improved the chances that Adasuve (loxapine delivered using Alexza's Staccato inhaler) will eventually be approved for marketing.

Adasuve is Alexza's lead drug candidate and was rejected by the FDA in October 2010 as a rapid treatment for agitation in schizophrenia and bipolar disorder following concerns that inhaling it caused an acute asthma-like reaction (bronchospasm) in some patients.

Alexza persevered and re-filed a marketing application for Adasuve with the FDA in May 2011, saying it believed the product fills an important niche in the treatment of psychosis.

The speed of onset of treatment with inhaled loxapine is comparable to the injectable route, but offers "greater ease, patient comfort and convenience" than injectable rivals, according to Alexza.

At the moment, agitation in psychotic patients is generally treated with injectable formulations of Eli Lilly's Zyprexa (olanzapine), Pfizer's Geodon (ziprasidone) and Bristol-Myers Squibb's Abilify (aripiprazole).

The FDA panel voted overwhelmingly in support of Adasuve's efficacy in treating agitation in schizophrenia and bipolar patients. It was not however convinced that a risk evaluation and mitigation strategy (REMS) proposed by Alexza - which focused on screening patients for lung problems and monitoring them for an hour after dosing - would ensure its safe use.

There were concerns that the patients selected for inclusion in Alexza's studies of Adasuve had been pre-screened for lung problems and so were not representative of the population that might present in real-world emergency room settings.

As a result, the committee voted 11-5 that a more stringent REMS developed by the FDA should be used, and also concluded that the use of Adasuve should be limited to one dose per day.

The FDA is scheduled to deliver a verdict on the application by February 4, 2012. If approved, it will be sold by Valeant Pharmaceuticals and analysts have suggested it could achieve sales in the region of $100-$150m a year.

Alexza filed for approval of the drug in October in the EU, where it will be sold by Grupo Ferrer International.

14th December 2011

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