logo-loader
viewAlexza Pharmaceuticals

Alexza Pharmaceuticals gets FDA approval for schizophrenia, biopolar treatment

drug_research_350_50d85dfe52c78.jpg

Alexza Pharmaceuticals (NASDAQ:ALXA) late Friday said that its Adasuve inhalant was approved by the FDA to treat agitation in adults with schizophrenia and bipolar disorder.

The new, non-injectable therapy uses Alexza's proprietary Staccato hand-held inhaler, with the antipsychotic drug, loxapine. 

The company said the inhaler delivers a drug aerosol to the deep lung that results in rapid systemic delivery and absorption. 

"The approval of Adasuve is an important event in the treatment of agitation," said president and CEO Thomas B. King.

"This is a landmark day for Alexza and we are proud of our accomplishments in developing this unique product. We project that Adasuve will be available for commercial launch early in the third quarter of 2013."

Alaza said that the FDA approval is based on clinical data from more than 1,600 patients and subjects. In two phase 3 trials, Adasuve was found to be effective and met the primary efficacy endpoint, with "statistically significant" reductions in agitation as compared to placebo.

Of note, said the company, was that the therapy produced results within about 10 minutes.

Adasuve can, however, cause bronchospasm, which has the potential to lead to respiratory distress and respiratory arrest, and so will only be offered through a restricted program.

As part of the recent approval, Alexza said the drug also has "several post-approval requirements", including  futher clinical trials to determine the safety of the treatment in adolescents.

Alexza is a pharmaceutical company focused on the research, development and commercialization of products for the acute treatment of central nervous system conditions. 

Adasuve is Alexza's lead therapeutic program. Earlier this month, the company received "a positive opinion" from the European Medical Association, recommending the approval of Adasuve in the European Union. 

The company noted that the European Commission is now expected to grant marketing authorization for Adasuve in all 27 European Union Member States, plus Iceland, Lichtenstein and Norway. 

A decision is expected from the European Commission in the first quarter of 2013.

Quick facts: Alexza Pharmaceuticals

Price: - -

NASDAQ:ALXA
Market: NASDAQ
Market Cap: -
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

Full interview: Opyl is new name of digital health track company ShareRoot

Opyl Limited (ASX:OPL) chief executive officer Michelle Gallaher updates Proactive on the renaming of the global digital health track company formerly known as ShareRoot Ltd (ASX:SRO). This heralds the company’s entry into the rapidly expanding global digital health and artificial...

1 hour, 31 minutes ago

2 min read