Alexza Pharmaceuticals Inc. said it can resolve the concerns about its drug-making facility that led regulators to deny market approval to the company’s antipsychotic treatment.
The Food and Drug Administration cited manufacturing deficiencies that affected its decision on Adasuve, which is designed to rapidly treat agitation related to schizophrenia and bipolar disorder, the Mountain View, California-based company said today in a statement. The FDA isn’t seeking more clinical data and Alexza said the manufacturing issues likely involve the the device used to deliver the inhaled drug.
Alexza plans to schedule a meeting with the FDA to gain a better understanding of the deficiencies, the company said in the statement. Once the company submits a response, the agency told Alexza it can continue discussions on a risk mitigation plan for the antipsychotic treatment that would screen potential patients for respiratory risks.
“Alexza looks forward to working to resolve the remaining issues in a timely manner,” the company said.
Alexza declined 43 percent to 35 cents in extended trading at 6:08 p.m. New York time. The shares declined 12 percent earlier to close at 61 cents before the company’s announcement about the FDA action.
Alexa in February fired 29 employees, or 38 percent of its workforce, to focus on development of Adasuve and sold 44 million shares, raising about $20.4 million, the company said in a statement. The company had hired Lazard Ltd. in December to explore strategic options, including selling itself.
U.S. sales of the drug were expected to reach $264 million in 2017, according to an e-mail from JMP Securities in San Francisco led by analyst Charles Duncan. The product would compete with injectable versions of Eli Lilly & Co.’s Zyprexa, Bristol-Myers Squibb Co.’s Abilify and Pfizer Inc.’s Geodon.
Adasuve failed to win approval in October 2010 because the FDA was concerned that the drug may produce adverse side effects. The treatment uses an inhalation device developed by the company to deliver a vaporized form of loxapine to the lungs for rapid absorption into the bloodstream. Alexza resubmitted its application in August.
The medicine can cause fatal bronchial spasms in people with asthma or chronic obstructive pulmonary disorder, FDA staff said in a December report.
Schizophrenia is a chronic and disabling brain disorder that affects 2.4 million American adults who may hear voices or falsely believe people are plotting against them, according to the National Institutes of Health. Bipolar disorder is a manic-depressive illness that causes shifts in a person’s mood and affects about 5.7 million adults in the U.S., according to the NIH.
A company-funded study published in January in the British Journal of Psychiatry found that Adasuve started to work within 10 minutes of inhalation and was more effective than a placebo in cutting agitation levels within two hours.
While loxapine was approved by the FDA in 1975, Adasuve would be the first inhaled treatment for agitation associated with schizophrenia and bipolar disorder.