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Alexza psychiatric drug delayed

Alexza Pharmaceuticals' schizophrenia treatment Adusuve Staccato has been delayed after concerns from the US Food and Drug Administration

Alexza Pharmaceuticals has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) voicing concerns about the safety of Adusuve Staccato (loxapine) inhalation aerosol.

The therapy is a development-stage rapid treatment for agitation in schizophrenia or bipolar disorder that 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 in February, shortly after Alexza submitted the New Drug Application (NDA).

The FDA has now issued a CRL to Alexza indicating that the application cannot be approved in its current form. The decision was based in part on the Center for Drug Evaluation and Research's (CDER) concerns about data from three phase I pulmonary safety studies that suggested lung function may be impaired in patients with chronic obstructive pulmonary disease 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. 

The respiratory symptoms were either self-limiting or easily managed with an inhaled bronchodilator, and there were no serious adverse respiratory events, according to the company.

CDER also questioned the suitability of the stability studies performed for the drug "and certain other items relating to the FDA's recently completed pre-approval manufacturing inspection," Alexza reported.

In addition, the FDA's Center for Devices and Radiological Health, which participated in the review because of the drug's novel delivery system, requested a human factors study to ensure proper use in the proposed clinical setting and further bench testing of the product under a "worst-case" manufacturing scenario.

Alexza plans to meet with the FDA in the near future to discuss next steps, the company said.

Adusuve Staccato, which is Alexza's lead programme, uses the company's Staccato delivery system, which vaporises unformulated drug to form a condensation aerosol that allows for rapid systemic drug delivery through deep lung inhalation. The company said the system delivers a speed of therapeutic onset comparable to intravenous administration, but with more comfort and convenience.

12th October 2010

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