Nicobreak ODF was approved for the first time in Korea

CTCBIO's Nicobreak ODF

CTC Bio's'Nicobreak ODF', a smoking cessation treatment that melts and eats, was approved for the first time in Korea.

 

this.

 

This product has been confirmed to be equivalent to the existing Champix (Varenicline, Pfizer), which is the same ingredient product.

 

The Ministry of Food and Drug Safety approved two items of Nicobreak ODF1mg/0.5mg of CTCBIO on the 13th.

 

This product is a varenicline, such as Pfizer's Champix, and is used as an adjuvant therapy for smoking cessation.

 

In particular, this drug is the first ODF formulation in Korea that can be dissolved with the tongue without water.

 

Conventional Varenicline tablets should be swallowed with water.

 

Patients with difficulty swallowing or refusal to rehydration feel uncomfortable with the tablets.

 

ODF formulations are expected to increase ease of use by covering the disadvantages of these tablets.

 

After a smoking cessation date is set, this drug should be administered one week before the designated date.

 

Smoking can be started within 35 days from the 8th day after the drug administration.

 

For 1~3 days, 0.5mg once a day, 4~7 days 0.5mg twice a day, 1mg twice a day until the end of the administration after the 8th day.

 

Champix

▲ Pfizer's anti-smoking treatment This drug has been compared to Champix to confirm its equivalence.

 

As a result of measuring the plasma concentration of varenicline in 28 healthy adults taking THIS DRUG and Champix, it was demonstrated that the 90% confidence interval of the mean difference was bioequivalent from log 0.8 to log 1.25.

 

Nicobrec's oral melting film is also different from Champix' salt.

 

This drug differs from Champix's tartrate because it has salicylate.

 

Champix's sales based on IQVIA last year were 20.7 billion won, and it is 10 billion blockbuster drugs despite the decrease in the number of nationally supported smoking cessation.

 

Equivalence check with Champix CTCBIO Nicobreak ODF, a dissolving smoking cessation treatment, succeeded in obtaining approval for the first time in Korea.

 

This product has been confirmed to be equivalent to the existing Champix (Varenicline, Pfizer), which is the same ingredient product.

 

On the 13th, the Ministry of Food and Drug Safety approved two items of Nicobreak ODF 1mg/0.5mg of CTCBIO.

 

This product is a varenicline, such as Pfizer's Champix, and is used as an adjuvant therapy for smoking cessation.

 

In particular, this drug is the first ODF formulation in Korea that can be dissolved with the tongue without water.

 

Conventional Varenicline tablets should be swallowed with water.

 

Patients with difficulty swallowing or refusal to rehydration feel uncomfortable with the tablets.

 

ODF formulations are expected to increase ease of use by covering the disadvantages of these tablets.

 

After a smoking cessation date is set, this drug should be administered one week before the designated date.

 

Smoking can be started within 35 days from the 8th day after the drug administration.

 

For 1~3 days, 0.5mg once a day, 4~7 days 0.5mg twice a day, 1mg twice a day until the end of the administration after the 8th day.

 

This drug has been compared to Champix to confirm its equivalence.

 

As a result of measuring the plasma varenicline concentration of 28 healthy adults taking THIS DRUG and Champix, a 90% confidence interval of the mean difference was within log 0.8 to log 1.25, demonstrating bioequivalence.

 

Nicobreak ODF is also different from Champix' salt.

 

This drug differs from Champix's tartrate because it has salicylate.

 

Champix's sales based on IQVIA last year was 20.7 billion won, which is a 10 billion blockbuster drug despite the decrease in the number of nationally supported cessation cessation applicants.