|Title||IND filing of once-daily Tianeptine|
On the day of 23rd, GL PharmTech (CEO, Hun Sik Wang, Yu Jin Choi) drew an attention from pharmaceutical industry as the company announced that the company has filed IND for Phase Ⅰ clinical trial of once-daily Tianeptine to the KFDA.
Tianeptine GLARS contains Tianeptine 37.5mg, which triples that of Stablon(Tinaeptine Na 12.5mg) launched as tri-daily administration by Jeil Pharma.
"The same technology, which was applied to the development of Tamsulosin 0.4mg GLARS, was applied. The new drug was designed to have 4-layered film, characterized by continuous efficacy maintenance during day and night by inducing additional drug absorption in the large intestine and by increasing late blood concentration compared to the conventional CR (controlled-release) drug." CEO, Mr. Wang said.
"Multiple-daily medication of the conventional drug reduces blood concentration during medication interval, which results in efficacy reduction. Continuous maintenance of efficacy for a long time is recommended for psychoneurologic drugs such as antidepressant" he added.
Most SSRI (selective serotonin reuptake inhibitor) drugs, which represent antidepressant, are once-daily CR drugs.
The domestic sales revenue of Stablon exceeded 10 billion won in 2009, and reached approximately 5.9 billion won in the first half of this year.
GL PharmTech emphasized that it is also preparing for technology licensing of the new drug to France.