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Alexza schizophrenia drug delayed

The US Food and Drug Administration has refused to accept Alexza Pharmaceuticals' new drug application for an inhaled schizophrenia therapy in its current form
The US Food and Drug Administration (FDA) has refused to accept Alexza Pharmaceuticals' New Drug Application (NDA) for an inhaled schizophrenia therapy in its current form. The company said it will work to address the agency's concerns and plans to resubmit the application in July, after which it expects that the FDA will take six months to review the resubmitted application.  

Alexza said it had completed an end-of-review meeting with the FDA for Adusuve Staccato (loxapine) inhalation aerosol, which is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients. The drug is the first to use the company's Staccato technology, which vaporises an unformulated drug to form a condensation aerosol that allows for rapid systemic delivery through deep lung inhalation. 

"Based on the guidance received in our end-of-review meeting, we believe all of the issues raised in the CRL are resolvable," said Thomas B King, Alexza's president and CEO. The company reported that the FDA has said it will likely present the resubmitted application to an advisory committee. 

The therapy is being developed through a licensing and partnership deal with Valeant Pharmaceuticals. Biovail Laboratories, which recently completed a merger with Valeant and became a subsidiary of the company, licensed the US and Canadian rights to the product from Alexza shortly after Alexza submitted the original marketing application. 

The FDA's complete response letter, issued in October 2010, was based in part on concerns about data that suggested lung function may be impaired in patients with chronic obstructive pulmonary disease (COPD) and asthma, as well as in healthy subjects, during the period after dosing. Impairment in lung function was also observed in patients in the device-only placebo group.  

"In the information package submitted to the FDA in response to the CRL and in preparation for the end-of-review meeting, Alexza presented evidence that the placebo device is safe," the company said. "Alexza believes this evidence and analysis confirms that the changes seen were likely background events in the population studied, where the repeated and extensive pulmonary function testing may have contributed to some of the observations." 

The FDA has asked Alexza to reiterate these arguments in its resubmission, the company noted. 

18th January 2011

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