Alexa’s Adasuve gets FDA nod

on Saturday, 22 December 2012. Posted in News, Products and Guidelines Written By: HealthTzars News Group

Alexa’s Adasuve gets FDA nod

A new drug, ‘Adasuve’ from Alexa Pharmaceutical Inc which is the first ever drug promising to treat schizophrenia and bipolar disorder has received FDA’s approval for commencing commercial sale from 2013. 

This new drug which can be inhaled will replace the older antipsychotic drug, Loxapine. It will pass though the lungs first and then into the bloodstream. The company said that the label of the drug will carry a boxed warning for chronic asthma or obstructive pulmonary disorder patients against using the drug since it can cause fatal bronchial spasms in them.

The drug is also declared unsafe for elderly people with dementia-related psychosis since it increases the risk of death in them. Sources form the company said that Adasuve's use will be restricted to reduce the potential harm of bronchial spasm only. The FDA has asked the company to conduct large-scale post-marketing clinical trials of patients in order to assess the real-world scope for use of the drug.

The Chief Executive of the company, Thomas King said that the ability of doctors to administer the medication quickly and non-invasively is of importance for both the patients and doctors attending to them. At present, three injectable drugs; Abilify- from Bristol Meyers Squibb, Zyprexa-from Eli Lilly and Geodon-from Pfizer Inc are available for treating patients suffering from schizophrenia and bipolar disorder by calming them down.

The new drug will be available for sale in the third quarter of 2013. Earlier this month, the European health regulators have also approved sale of this drug.

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