Alexza Pharma ($ALXA) just barely managed to clear one of the big hurdles that threatened to once again block its marathon effort at winning an FDA approval of the inhaled antipsychotic treatment Adasuve (formerly AZ-004). An expert FDA committee voted 9 to 8 in favor of an approval yesterday evening, with a number of critics clearly remaining unhappy with the safety issues that have hobbled the program before.
Just days ago investors were dumping shares in Alexza after reading regulators' concerns about the potentially lethal pulmonary effects of the treatment in patients with asthma or COPD. Those same risks persuaded the FDA to reject Alexza's initial try at an approval. But a majority of the FDA panel felt that the biotech's risk mitigation strategy, which would demand that patients are carefully screened and then monitored for the first hour after treatment, satisfied their safety concerns.
"This product offers the potential to be a significant contributor to an important need," noted Andrew Winokur, director of psychopharmacology at the University of Connecticut School of Medicine in Farmington, according to a report from Bloomberg. Alexza provided "impressive efficacy data."
Adasuve is a vaporized version of the old antipsychotic loxapine. Inhaling it with the use of a new device developed by Alexza offers a quick method for dealing with bouts of schizophrenia and bipolar mania. But a number of specialists in the FDA remain worried that the drug could wind up in the wrong hands, or administered without all the necessary precautions.
Investors, who have alternately fled and embraced Alexza's shares, initially responded to the positive vote by pushing its battered shares up more than 70%. By mid-morning some of those gains had been given up as analysts considered Alexza's chances at finally winning an approval from a skeptical FDA. Some analysts say an approval could pave the way to a market worth about $150 million in annual revenue.
Alexza now faces a PDUFA deadline on February 4.
- read the press release
- here's the report from Bloomberg