SK Chemicals announced on Dec. 12 that it has received final approval from the U.S. Food and Drug Administration (FDA) to sell its dementia treatment patch “SID710” (ingredient name is Rivastigmine) in the U.S. market. It is the first time for a dementia treatment patch developed by a Korean pharmaceutical company to win approval from the U.S. FDA.
The patch is designed to steadily deliver medication through the skin. With a decline in cognitive skills, dementia patients find it hard to keep time and count of medication administration, or swallow pills. So it is difficult for them to administer medication in time. However, a treatment in the form of a patch can work as long as it is applied. Patients only need to apply the patch once a day. Particularly, it is as effective as pills but has fewer side effects such as nausea, vomiting, or infection and less burdensome to the stomach and liver.
At present there is only one product available as a patch-type dementia treatment, which a global pharmaceutical company developed and released in 2007. The dementia treatment patch, a new entry in the market dominated by oral medications, has created a huge market with yearly sales of US$1.2 billion globally since it was first put on sale in the EU in 2007.
In 2007, most medical industry watchers forecasted that other drug makers could not enter the patch treatment market due to the high technical barriers of the transdermal delivery system (TDS), the key to development of dementia treatment patches.
SK Chemicals successfully developed the country’s first dementia treatment patch “SID710” in 2010, which was made differently from the way conventional treatments were produced. SK Chemicals already developed an arthritis treatment patch “Trast” in 1995 and accumulated know-how in patch development.
The company was ready to export its finished products as its production facilities had obtained the EU’s Good Manufacturing Practices (GMP) certification.
SK Chemicals passed the biological equivalence test for SID710 in 2012 based on its own TDS technology, making it the first generic approved in Europe. Since then, thanks to an expanded global market for dementia treatments and its vigorous marketing, the company has taken first place with a 50 percent share in the European generic market.