Kolon wins approval on inhaled schizophrenia treatment

A treatment developed by U.S.-based Alexza, earned FDA approval in December 2012

An orally inhaled medicine for treating agitation associated with schizophrenia is to be released in Korean market for the first time.

 

The public’s interest is heightened by the news as inhalation powder has higher speed of body absorption and delivers effect in the shortest time.

 

, Korean Ministry of Food and Drug Safety (MFDS) on Dec.

 

5 granted an approval on Kolon Pharma’s license to market Adasuve (loxapine) inhalation powder (10 mg).

 

Adasuve is used as an acute treatment of mild and severe agitation associated with schizophrenia or bipolar disorder in adults.

 

When inhaled with hand held drug delivery technology system ‘Staccato’, powdered loxapine is rapidly absorbed by the lung and achieve maximum plasma concentration in approximately two minutes.

 

The drug’s administration is limited to single 10 mg dose within 24 hours.

 

The approved label of the drug requires it to be administered only by a healthcare professional with immediate on-site access to equipment and personnel trained to manage acute bronchospasm.

 

Developed by a U.S.-based company Alexza Pharmaceuticals, Adasuve was approved by the U.S.

 

Food and Drug Administration (FDA) as the first orally inhaled treatment for schizophrenia in December 2012.

 

Currently, Teva has the license to market the treatment in the U.S.

 

Loxapine has been used for schizophrenia before Adasuve, as products like Loxapac used to be available in Korea.

 

But now there is no other approved product with the same substance.

 

In clinical trials with over 650 patients with acute agitation, Adasuve confirmed reduction of the condition more statistically significant than placebo.

 

Multiple patients treated with the treatment experienced serious reaction of bronchospasm.

 

Patients with asthma, COPD and other lung disease who inhaled the treatment were often reported with bronhospasm, and they were then treated a short-acting beta-agonist bronchodilator.

 

The most commonly reported adverse reactions were dysgeusia, sedation and throat irritation.

 

MFDS designated the treatment as a subject for Risk Management Plan (RMP) to continue monitor its adverse events after the commercialization.