SK Chemicals has released the results of its clinical trials of the overactive bladder syndrome treatment compound THVD-20, whose approval in Korea is unclear, not here but abroad triggering questions as to why.
The Central Pharmaceutical Affairs Council at the Ministry of Food and Drug Safety (MFDS) 식품의약품안전처 concluded in July the development of THVD-201 had no commercial viability.
SK ChemicalsSK케미칼 received the notice from the council in August and canceled its application for approval, but has yet to decide whether to re-apply or give it up.
|SK Chemicals announced the clinical result of THVD-201 at the International
Continence Society 2017 (ISC) from Aug. 12-15 in Florence, Italy.
It is against this backdrop SK Chemicals released the clinical result of THVD-201 at the International Continence Society 2017 (ISC), the world’s most prestigious conference in dysuria and urinary incontinence, held from Aug. 12-15 in Florence, Italy.
THVD-201 is a therapy which combines tolterodin and pilocarpine compounds to treat the overactive bladder and dry mouth caused by existing therapies at the same time.
Since 2015, 16 Korean hospitals, including Samsung Medical Center(SMC)삼성서울병원, have conducted phase 3 clinical trial with the participation of 386 patients with the overactive bladder syndrome.
“THVD-201 maintained its efficiency as the overactive bladder therapy and effectively reduced dry mouth in the 24-week trial. And the drug secured safety from the long term intake,” said Lee Kyu-sung, a professor at SMC and the presenter.
“The only side effects of the medicine that increased compared with existing tablet were hyperptyalism. It also showed indigestion and headache, but they weren’t much of problems because their occurrence rate was low and the symptoms weren’t serious,” Lee said.
However, the ministry asked the council for advice about THVD-201 because dropout rate among subjects was high and the number of patients benefitted from the drug was limited.
The council doubted the need to develop the drug for reasons, such as the AUC increase in the compound, the dropout rate two times higher in the group to take it, and the lack of prescriptions to take pilocarpine to treat dry mouth. Finally, the ministry saw no validity in approving THVD-201. Currently, SK Chemicals stopped the processes to get the approval.
“The ministry didn’t’ acknowledge feasibility to develop the drug, and it is true we canceled the approval processes. But we are supposed to release the clinical results at ICS 2017,” a company official said. “We haven’t decided whether to restart the approval processes or give up, or conduct the process in foreign countries.”
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