Alexza's Adasuve slapped with delayed FDA review

The FDA slammed Alexza Pharmaceuticals ($ALXA) with another setback this week in its drive to bring the antipsychotic drug Adasuve to market. Regulators are extending by three months their review of the drug--an inhaled, fast-acting formulation--which will hopefully be completed now by May 4. FDA's original review deadline was Feb. 4.

Adasuve is a vaporized form of loxapine, a longtime antipsychotic that has been available orally to treat adults for schizophrenia-related agitation or bipolar I disorder. Alexza houses the drug in its proprietary hand-held Staccato inhalation device that delivers the treatment in a vaporized form directly to the lungs, which helps it reach the bloodstream quickly.

An FDA panel of experts in December recommended Adasuve's approval in a split vote, but in a nod to safety concerns wanted to limit the dosing to once daily and follow the FDA's risk-mitigation plan. (The FDA previously rejected the drug, in part due to concerns about pulmonary toxicity.) And that's where the regulatory review delay comes in. As Reuters reports, Alexza submitted an amendment to its NDA earlier this month intended to address the panel's safety and dosage recommendations. FDA chose to extend its review under what is known as the Prescription Drug User Fee Act, or PDUFA, to take more time to review the changes.

The thing is, investors weren't happy with the news, initially sending Alexza's shares plunging as much as 19%, according to Reuters. And Mountain View, CA-based Alexza has already considered significant job cuts, and options including a possible asset sale or partnership deal, in order to save cash so Adasuve makes it to the FDA regulatory finish line.

If Alexza does succeed, Adasuve will compete with injectable drugs manufactured by Bristol-Myers Squibb ($BMY), Eli Lilly ($LLY) and Pfizer ($PFE) for the same indications, Reuters notes.

- here's the Reuters story
- read Alexza's release

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