Alexza’s Generic Drug Rx Rejected Due to Lung Problems Associated with Drug
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Stocks have dropped considerably for drug rx company Alexza, whose pivotal medication AZ-004 was denied approval by the FDA this week. The drug, which contains staccato loxapine to help combat the effects of bipolar disorder and schizophrenia, was designed to be administered with a plastic inhaler. However, the FDA deemed the drug unsafe due to pulmonary concerns and respiratory side effects in both asthmatics and healthy patients after Phase I of the study was completed.
Drug RX AZ-004 – The Risks
In addition to potential reparatory problems, the FDA also raised concerns about the drugs’ manufacturing and safety testing. Despite its approval setback, Alexza still remains hopeful that its inhalant drug will be approved for use pending new clinical data within the next 18 months.
Alexza maintains that respiratory problems developed in sufferers of Chronic Obstructive Pulmonary Disease and asthma were effectively managed with an inhaled bronchodilator.
Staccato loxapine belongs to a class of anti-psychotic prescription drugs and works by altering nerve channels in the brain to reduce agitation symptoms and is currently taken as a daily oral medication under the brand name Loxitane. Currently, sufferers of bipolar disorder and schizophrenia use slower-acting oral medications and IM injections to treat severe acute agitation symptoms. Acute agitation occurs in mental disorder sufferers about an average of 11-12 times per year.
Bipolar disorders and schizophrenia affect a combined 7.5 million Americans nationwide. No restrictions have been placed on the sale of the drug rx loxapine’s oral brand name, Loxitane.
