"C-Trelin proven effective for SCD treatment…reimb needed"

Doctors·patients, "No effective treatment available for SCD"

The efficacy·safety of C-Trelin Orally Disintegrated Tab were demonstrated in the large-scale Phase 4 clinical trial, which enrolled 160 study participants

This drug has been a non-reimbursable drug since its approval in 2015…Based on Phase 4 trial results, HLB Pharma is reapplying for reimbursement

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There is currently no standard therapy available for 'spinocerebellar degeneration (SCD).' Doctors write prescriptions based on a patient's condition, but there are still unmet needs in 'SCD treatment.' Patients affected by disease likewise.

 

SCD is a degenerative disease affecting the cerebellum or spinal cord due to various underlying causes.

 

Ataxia and dysarthria commonly occur at an early stage, but the disease progression accompanies complications, including dysfunction of the heart, lungs, spine, and bones, causing the risk of death.

 

Other diseases have specific medications; for instance, 'Levodopa' is used for Parkinson's disease and 'aspirin' is used for cerebral thrombosis.

 

However, there is currently no major medication available for SCD.

 

This is because no medication has been proven to improve symptoms or slow down disease progression.

 

The efficacy and safety of C-Trelin Orally Disintegrated Tab (taltirelin hydrate) was demonstrated in large-scale Phase 4 clinical trials in patients with SCD.

 

Dr.

 

Seong Beom Koh, Professor at the Korea University Guro Hospital's Department of Neurology who led the Phase 4 clinical trial, stated, "None of the medications used in patients with SCD are better than C-Trelin Orally Disintegrated Tab." "C-Trelin Orally Disintegrated Tab has proven effective and safe in patients with SCD.

 

Its oral formulation also yields favorable patient compliance.

 

It means that it is a valuable treatment for patients.

 

We should widely use this medication through reimbursement." The efficacy and safety of the drug has been demonstrated in the large-scale Phase 4 trial The clinical trial was published in the Journal of Movement Disorder under the title, 'The Efficacy and Safety of C-Trelin Orally Disintegrated Tab in Patients with ataxia induced by SCD.' The clinical trial involved 160 study participants, including randomly assigned 79 experimental group and 81 control group, and the results showed a significant reduction in the K-SARA (Korean version of Scale for the Assessment and Rating of Ataxia), objective evaluation index for ataxia at 24 weeks treatment, thus confirming the statistical significance of the drug.

 

The standing up and impairment in language entries showed that the average difference in K-SARA of the experimental group was statistically lower than that of the control group.

 

While no suitable medication is available for ataxia in SCD, publication of the Phase 4 trial results in the international journal is significant.

 

Doctors are stating the importance of providing reimbursement for C-Trelin Orally Disintegrated Tab.

 

"C-Trelin Orally Disintegrated Tab is an oral tablet required twice daily.

 

This drug had no significant issue based on the clinical trial evaluating the efficacy and safety.

 

Patient tolerance was favorable, and there were no side effects after administration.

 

To date, no other treatments administered to patients with SCD are said to be efficacious than this drug.

 

Therefore, this drug provides a valuable treatment option for patients with SCD," Dr.

 

Koh remarked.

 

"C-Trelin Orally Disintegrated Tab may require long-term use, which can be costly.

 

This drug should be considered for patients with good mobility and could benefit from it.

 

If a drug is as effective as this, we should pursue active treatment options through reimbursement," Koh added.

 

'C-Trelin Orally Disintegrated Tab 5 mg' obtained the Ministry of Food and Drug Safety (MFDS) approval in 2015.

 

It costs KRW 4,900 per tablet as a non-reimbursable drug.

 

Two tablets per day cost KRW 9,800 daily and cost KRW 3.5 million yearly.

 

Doctors say that without National Health Insurance reimbursement coverage, it is practically impossible for patients, about 80% of those who do not have jobs, to continue taking the drug that requires long-term administration.

 

Based on these clinical trial results, HLB Pharmaceutical has recently applied for reimbursement again.