The Brain disease prescription market disappears

in a year

Oxiracetam Clinical Reassessment Failed

Last year, Acetyl-L-Carnitine failed to prove its efficacy

Pharmaceutical companies lost 30 billion won a year due to Oxiracetam.

 

Prescription loss became a reality as it failed to prove its efficacy in an eight-year clinical re-evaluation.

 

Following acetyl-L-Carnitin last year, the annual prescription market worth 100 billion won has disappeared due to the failure of clinical re-evaluation of cerebrovascular-related drugs over the past year.

 

According to the Ministry of Food and Drug Safety on the 18th, prescription and preparation were suspended because Oxiracetam failed to prove the effectiveness of "improving symptoms of vascular cognitive impairment" as a result of clinical trial reevaluation.

 

Oxiracetam has been licensed to improve cognitive impairment due to Alzheimer's type dementia, multiple infarction dementia, and organic brain syndrome caused by brain failure.

 

Cognitive disorders include decreased memory, attention, and concentration, speech and behavioral disorders, emotional anxiety, and lack of motivation.

 

The Ministry of Food and Drug Safety announced the clinical re-evaluation of Oxiracetam in March 2015.

 

According to the clinical revaluation design, indications were adjusted in 2019 due to the improvement of vascular cognitive impairment.

 

Oxiracetam's deadline for submitting clinical re-evaluation data was set in March 2019, but the deadline for submitting the data was extended twice and finally closed in June last year.

 

As a result of reviewing the clinical trial data, it was concluded that it failed to prove its efficacy, and decided to discontinue the prescription.

 

As a result, Oxiracetam is expected to lead to the deletion of indications and exit from the market eight years after the announcement of clinical re-evaluation.

 

According to UBIST, a drug research agency, the number of outpatient prescriptions for Oxiracetam last year was 21.3 billion won.

 

Oxiracetam formed a prescription market of 30.8 billion won and 31 billion won in 2017 and 2018, respectively.

 

Since the adjustment of indications in 2019, the prescription volume in 2020 has decreased by 26.6% from two years ago to 22.6 billion won, and the decline has continued in 2021 and last year.

 

According to the prescription amount by item, Korea Pharmaceutical's Neuromed showed the largest prescription performance of KRW 11.8 billion last year.

 

This clinical re-evaluation means that Korea Pharmaceutical will lose 11.8 billion won annually.

 

Samjin Pharmaceutical's Neuracetam recorded 5.1 billion won in prescriptions last year, while Hwanin Pharmaceutical's Neuoxitam and Kwangdong Pharmaceutical's Neuropia raised 2.8 billion won and 1.5 billion won, respectively.

 

As a result, drugs related to brain diseases will be removed from the market for the second consecutive year following acetyl-L-Carnitin last year due to failed clinical re-evaluation.

 

Dong-A ST's Nicetile, acetyl-L-Carnitin, has been approved for use in "primary degenerative disease" or "secondary degenerative disease caused by cerebrovascular disease." In 2013, the Ministry of Food and Drug Safety ordered a clinical re-evaluation of acetyl-L-carnitine drugs.

 

The re-evaluation clinical trial was conducted in two groups according to indication.

 

Dong-A ST took the lead in conducting a clinical trial of "primary degenerative disease." Hanmi Pharmaceutical was in charge of clinical trials of "secondary degenerative diseases caused by cerebrovascular disease." As a result of clinical trials, the indication was deleted in July 2019 because it failed to prove the primary degenerative disease.

 

In August last year, it was concluded that the "secondary degenerative disease caused by cerebrovascular disease" also failed to prove its effectiveness.

 

In other words, as a result of nine years of clinical re-evaluation, all indications were not proven, leading to the exit procedure.

 

Acetyl-L-carnitine preparations also suffered from clinical design.

 

It is known that it took about two to three years to set up a clinical design while designing a new clinical trial reflecting the latest scientific standards.

 

At the request of the pharmaceutical company, the deadline for clinical re-evaluation of primary degenerative diseases was extended by two years, and the submission of clinical trial data for secondary degenerative diseases was extended by four years, which resulted in failure.

 

Acetyl-L-Carnitin drugs formed an outpatient prescription scale of 72.6 billion won in 2017 and 74.8 billion won in 2018, but fell to 64 billion won and 51.1 billion won in 2019 and 2020, respectively.

 

With the deletion of the first indication, the market size has been reduced.

 

Last year, the prescription record was 31.6 billion won, but it finally disappeared from the market.

 

As of last year, Hanmi Pharmaceutical's Carnitil left 11 billion won and Dong-A ST's Nicetile left 5 billion won in prescriptions.

 

In 2017 and 2018, Oxiracetam and acetyl-L-Carnitin collaborated on a total of 103.4 billion won and 105.9 billion won in prescriptions.

 

The pharmaceutical industry has become inevitable to lose about 100 billion won a year due to the failure of clinical re-evaluation of oxiracetam and acetyl-L-carnitine drugs.