Spray formulation of 'nicotine' wins nod in KOR as OTC

Used as a smoking cessation aid

MFDS granted approval of J&J's Nicorette QuickMist

Spray formulations are widely used as OTC products overseas…concerns about it being classified as a prescription drug in 2019

Product photo of Nicorette QuickMist sold overseas

A spray formulation containing nicotine, which is used as a smoking cessation aid, received its first approval in Korea.

 

The nicotine spray was previously discussed for classification as a prescription drug in 2019, but this time it obtained approval as an over-the-counter (OTC) drug that is exempt from safety and efficacy review.

 

Spray formulations are widely used as OTC products overseas.

 

On September 15, the Ministry of Food and Drug Safety (MFDS) approved Johnson & Johnson Korea's 'Nicorette QuickMist Mouthspray (nicotine).' This drug is an adjunct therapy for smoking cessation and is used to relieve nicotine cravings and withdrawal symptoms.

 

As a nicotine replacement therapy (NRT), it reduces cravings and withdrawal symptoms by allowing nicotine to be absorbed through the oral mucosa.

 

This drug is used in three stages: In Stage 1 (weeks 1-6), one spray is used when a craving to smoke arises.

 

In Stage 2 (weeks 7-9), the daily usage is gradually reduced, with the goal of using half the average number of sprays used during Stage 1 by week 9.

 

In Stage 3 (weeks 10-12), if the usage has been reduced to 2-4 times a day, the use of this drug should be discontinued.

 

Complete smoking cessation is required while using the oral spray.

 

The method of use is to open the mouth, bring the spray nozzle as close to the mouth as possible, and press firmly on the top of the spray to dispense it, avoiding the lips.

 

J&J's Nicorette is a leading brand of smoking cessation aids sold in pharmacies.

 

In Korea, three formulations are currently sold: Nicorette Gum, Nicorette Lozenges Coolmint, and Nicorette Invisi Patch.

 

While the spray formulation is sold overseas, it had not been launched in Korea due to concerns over potential misuse and abuse.

 

It has reportedly been sold as an OTC product in the UK for nearly 20 years.

 

In 2019, the MFDS Central Pharmaceutical Affairs Advisory Committee (CPAC), while discussing approval for the nicotine spray formulation, had shared the opinion that classifying it as a prescription drug was appropriate.

 

At that time, 5 out of 7 committee members favored a prescription drug classification due to concerns about misuse by adolescents.

 

Subsequently, the nicotine spray formulation was not approved.

 

Six years later, with MFDS granting approval for this drug as an OTC drug, which offers good consumer accessibility, it is gaining attention whether this market will become more active.

 

The approval process also excluded a safety and efficacy review.