Here it comes: spray antipsychotic –Loxapine inhaler by Alexza pharmaceuticals
It’s not a pill, it’s not a dissolve under the tongue, it’s not a patch, it’s an inhaler designed for agitated patients with Schizophrenia or bipolar disorder.
Alexza Pharmaceuticals wants your business. Look out involuntary psych ward patients, the injectables forced upon you could have competition.
Study in British Journal of Psychiatry shows positive data, and sponsored by the drug company itself Alexza. That’s conflict of interest, and it’s to their best interest isn’t it?
Respiratory failure a concern of the FDA
„Alexza Pharmaceuticals Inc. (ALXA)’s inhaled antipsychotic drug may put some patients at risk for respiratory failure, according to U.S. regulators considering whether to approve the treatment for sale.
While Adasuve is effective as a fast-acting treatment for agitation among patients with schizophrenia and bipolar disorder, it can cause bronchial spasms that may be fatal in people with conditions such as asthma, Food and Drug Administration staff said today in a report. Outside advisers to the agency plan to meet Dec. 12 to evaluate the findings.
Adasuve would be the first product for Mountain View, California-based Alexza. The therapy uses an inhalation device developed by the company to deliver a vaporized form of the antipsychotic medication loxapine to the lungs for rapid absorption into the bloodstream. The FDA aims to decide on the product by Feb. 4.
“It is likely that, even with adequate screening for pulmonary risk factors, some patients will require respiratory support post-dose, and some patients will be at risk for respiratory failure and death,” FDA staff said.
The drug, if approved, should only be administered by professionals who have intubation tubes and ventilators “readily available,” according to the report.
Adasuve failed to win FDA approval in October 2010, because the agency was concerned about risks of pulmonary toxicity, particularly in patients with asthma or chronic obstructive pulmonary disorder.“-Bloomberg
Here’s the update from the FDA panel December 12, 2011
Adam Feuerstein, Sr. Columnist at The Street
$ALXA final final vote — 9 yes, 8 no, 1 abstain. split vote.“
December 12, 2011
„U.S. drug advisers recommended approving an experimental treatment from Alexza Pharmaceuticals for calming down patients with schizophrenia or bipolar disorder, but placed restrictions on how the drug should be used.
Advisers to the Food and Drug Administration on Monday voted 9 to 8 that Adasuve should be approved, but only if it is given in a single dose in 24 hours, and with the FDA’s safety strategy.
Adasuve caused some breathing problems for patients, especially for those who already had lung issues, and panelists were concerned such patients would not be properly screened in the real world with Alexza’s safety strategy.
The FDA usually follows the recommendation of its advisers, and will make the final decision on Adasuve in early 2012.“
There you have it. Inspite of the respiratory issues, the drug goes to market. Good luck,to those who have a doctor prescribe this inhaled antipsychotic.