Eyes on approval of ‘acetaminophen+ ibuprofen’ combo OTCs

First approved as OTC by the U.S FDA last year… has better effect than as monotherapy

OTC approval of the combo was turned down in 2017 in Korea… due to concerns on abusing and safety

MFDS to discuss approval at the Pharmaceutical Affairs Council meeting on the 17th

미국에서 OTC로 발매된 최초의 아세트아미노펜+이부프로펜 복합제 <애드빌 듀얼 액션>

The Ministry of Food and Drug Safety (MFDS) is reviewing the approval of an acetaminophen and ibuprofen combination therapy as an over-the-counter drug (OTC).

 

The two ingredients are well-known antipyretic-analgesics, however, the combination of only these two ingredients was not commonly used as the two have different mechanisms of actions.

 

However, with the U.S Food and Drug Administration (FDA) approving the first acetaminophen and ibuprofen combination drug as an OTC, the possibility of seeing the combination in Korea is also rising.

 

According to the MFDS on the 13th, the members of the Central Pharmaceutical Affairs Council will be discussing whether to classify the acetaminophen and ibuprofen combination as an OTC and the appropriateness of its approval at the meeting on the 17th.

 

No combination drug with only the acetaminophen and ibuprofen ingredients has been approved in Korea yet.

 

However, the combination has been approved overseas.

 

In March last year, the U.S.

 

FDA approved GSK’s ‘Advil Dual Action,’ which contains acetaminophen and ibuprofen.

 

This was the first case where an ibuprofen and acetaminophen combination drug was approved as OTC in the U.S.

 

Advil Dual Action contains 250 mg of ibuprofen and 500 mg of acetaminophen.

 

In clinical trials, a fixed-dose combination of the two components demonstrated a superior effect compared to the individual components alone.

 

The drug was officially released as an OTC in the U.S market in September last year.

 

There had been attempts to receive approval of the ibuprofen and acetaminophen combination as an OTC in Korea as well.

 

In 2017, Hanmi Pharmaceutical submitted an application for the approval of the combination as an OTC but was rejected.

 

The Central Pharmaceutical Affairs Council that discussed the OTC designation of the combination then did not approve the product due to concerns about drug abuse.

 

The product contained 500 mg acetaminophen and 200 mg ibuprofen.

 

The members of the council were concerned that people would be taking the drug regardless of their pain intensity, and that the approval will unintentionally increase the maximum dose intake of the two ingredients.

 

As a result, only 3 of the 8 members of the council agreed to the OTC permit, and the others opposed the decision.

 

The MFDS also expressed concerns over its safety.

 

MFDS opposed the OTC designation saying that the adverse reactions that occur from the two ingredients were similar and that there was a risk of gastrointestinal bleeding.

 

However, with the U.S FDA's approval of the drug as an OTC last year, the situation may change this time.

 

The MFDS and the experts usually refer to approvals abroad, especially those from the U.S FDA when making decisions.

 

Therefore, the possibility exists for the combination to see different results this time around at the Central Pharmaceutical Affairs Council meeting that will be held on the 17th.

 

An MFDS official confirmed that “It is true that a relevant product has applied for approval.”