The Food and Drug Administration cleared the inhaled treatment Adasuve for agitation associated with schizophrenia or bipolar disorder in adults, the company said today in a statement. The drug, recommended by European regulators for approval Dec. 14, will be the Mountain View, California-based company’s first product on the market.
The FDA rejected Alexza’s request to market Adasuve in May citing manufacturing deficiencies that the company said at the time probably involved the device used to deliver the drug. Adasuve is used with Alexza’s Staccato system that vaporizes the medicine and allows for rapid drug delivery through deep lung inhalation.
“We believe that the ability to deliver medications rapidly and non-invasively will be important for patients and the professionals who care for them,” Thomas King, the company’s president and chief executive officer, said in the statement. “This is a landmark day for Alexza and we are proud of our accomplishments in developing this unique product.”
Adasuve may generate an estimated $207 million in U.S. sales in 2016, Scott Henry, an analyst at Roth Capital Partners, said in an e-mail before the approval. The drug failed to win approval in October 2010 because the FDA was concerned that it may produce adverse side effects.
The company’s shares declined 6.9 percent to $5.79 at 2:39 p.m. New York time when trading was halted before the drug- approval announcement.
Of the estimated 3.2 million patients treated for schizophrenia or bipolar disorder in the U.S., about 90 percent suffer from agitation during their lifetime, Alexza said in its statement.
The product will include a boxed safety warning about potential dangerous side effects including the potential for fatal bronchial spasms in people with asthma or chronic obstructive pulmonary disorder and a higher risk of death in elderly people with dementia-related psychosis. Adasuve use will be restricted to mitigate potential harm of bronchial spasms, the company said.
The FDA also required Alexza to conduct a large post- marketing clinical trial of patients to assess “the real-world use” of the drug, the company said.
Alexza 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 in December 2011 to explore whether it should find a buyer.
Adasuve will compete with injectable versions of Eli Lilly & Co. (LLY)’s Zyprexa, Bristol-Myers Squibb Co.’s Abilify and Pfizer Inc.’s Geodon.
Zyprexa, from Indianapolis-based Lilly generated $4.6 billion in sales last year, according to data compiled by Bloomberg, though generic companies were able to begin making copies of oral versions of the drug in October 2011. New York- based Bristol-Myers’s Abilify brought in $2.8 billion last year and New York-based Pfizer’s Geodon earned $1 billion.
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