FDA whacks Alexza Pharma with CRL for Adasuve

Alexza Pharmaceuticals ($ALXA) was dealt another blow in its pursuit to gain approval of Adasuve from regulators. The FDA shot down the company's latest application because of manufacturing deficiencies related to the device used to take the inhaled antipsychotic drug, the company revealed last night.

The drug developer's shares tumbled 32.8% to 41 cents per share in pre-market trading.

U.S. regulators denied the company's application for Adasuve--a quick-acting inhaled version of the old drug loxaprine for outbursts from schizophrenia and manic episodes--in a complete response letter (CRL). The FDA stated in the CRL that manufacturing deficiencies would have to be addressed before Adasuve could be approved. Executives tried to put a positive spin on the CRL, pointing out that no new safety or clinical issues cropped up in the letter. But as biotech commentator Adam Feuerstein indicated on Twitter, that doesn't tell investors whether regulators felt that the company had resolved previous safety concerns. 

Adasuve promises patients with schizophrenia and biopolar I the benefits of easy administration and fast activity of loxaprine, The Wall Street Journal reported. Yet the inhaled version of the drug has raised concerns about its potentially deadly pulmonary effects and the risks associated with improper use of the treatment. Despite those concerns, the drug narrowly passed muster late last year in an FDA advisory panel's 9-8 vote to back approval. Yet the glow from that small victory quickly vanished when the FDA said in January that its decision on approval would be delayed by three months.

Alexza executives plan to address the CRL in a conference call this morning, no doubt in an effort to reassure investors that a way forward exists for the troubled program. The CRL also brought up the issue of Adasuve's product labeling and a REMS plan that has been proposed to limit potential dangers of the treatment, yet the details of those items were murky in the company's release.

- here's the release
- see the WSJ report

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