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FDA review of Alexza’s Adasuve delayed

Inhaled antipsychotic drug's REMS delays FDA decision to May, 2012

Alexza Pharmaceuticals will have to wait longer than expected before it gets the US Food and Drug Administration's (FDA) verdict on inhaled antipsychotic drug Adasuve, after the agency extended its review time for the application by three months.

The action date for the review has been put forward from February 4 to May 4, according to the FDA.

Adasuve (loxapine) is Alexza's lead product and is intended as a more patient-friendly alternative to injectable antipsychotics used to treat agitation in patients with schizophrenia or bipolar mania.

Alexza has a lot riding on the product. In December the company said it was planning to slash its workforce to conserve cash, and retained advisors to explore various options, including a possible sale of the firm.

News of the delay prompted a 15 per cent fall in Alexza's share price.

The extension of the review period is related to Alexza's submission earlier this month of Risk Evaluation & Mitigation Strategy (REMS) for Adasuve, which the company said has been designated a “major amendment” by the FDA.

Alexza filed the REMS following FDA advisory committee meeting, which narrowly recommended approval of Adasuve but was unconvinced by the company's REMS programme.

The committee asked Alexza to develop a more stringent strategy to ensure the product's safe use.

The FDA had previously rejected Adasuve in October 2010 on concerns that it may be linked to an asthma-like reaction (bronchospasm) in some patients.

In its original REMS, Alexza had proposed screening patients for lung problems and monitoring them for an hour after dosing.

Analysts have suggested that Adasuve could achieve sales of $100-$150m a year.

If approved, Adasuve will be marketed by Valeant Pharmaceuticals in the US and by Grupo Ferrer in Europe, where it was submitted for approval in October 2011.

25th January 2012

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