May 5, 2012 — The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) saying that the new drug application for loxapine inhalation powder (Adasuve, Alexza Pharmaceuticals, Inc) is not ready for approval in its current form.
Citing deficiencies at the Mountain View, California, manufacturing facility, the agency demanded their satisfactory resolution before granting approval.
According to a company news release, the deficiencies are medical device specific and readily addressable. Company officials plan to meet with the FDA as soon as practical in order to gain a "better understanding" of the specific problems and resolve remaining issues in a timely manner.
Once-daily loxapine inhalation powder, also known as "staccato loxapine," is absorbed into the bloodstream in 1 second via the company's Staccato inhaler, mimicking the therapeutic onset of intravenous drug administration.
As previously reported by Medscape Medical News, the FDA's Psychopharmacologic Drugs Advisory Committee recommended approval of the antipsychotic in December 2011 for the treatment of agitation associated with schizophrenia and bipolar disorder.
FDA approval of the drug was previously declined because of concerns regarding the effects of pulmonary toxicity, particularly in patients with asthma and chronic obstructive pulmonary disease.
According to the news release, no additional clinical or safety issues have been identified by the FDA.
Once a response to the action letter has been submitted, the company will be able to proceed with discussions regarding the required Risk Evaluation and Mitigation Strategy (REMS), which will include screening patients for respiratory risks and monitoring them for 1 hour after treatment.
Although the CRL also contained comments on draft product labeling, the company affirms that there is substantial agreement with the FDA on this issue as well as the REMS.
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Cite this: FDA Rejects Loxapine for Approval - Medscape - May 05, 2012.
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