Print（PDF/50KB） Jan. 21, 2011 Products

SUREPOST, a rapid-acting insulin secretagogue, obtains a manufacturing and marketing approval

Dainippon Sumitomo Pharma Co., Ltd. (DSP, Headquarters: Osaka, Japan; President: Masayo Tada) announced that the Company has obtained a manufacturing and marketing approval for "SUREPOST^® tablet 0.25 mg" and "SUREPOST^® tablet 0.5 mg" (generic name: repaglinide), a rapid-acting insulin secretagogue, in Japan as of January 21, 2011 from the Ministry of Health, Labor and Welfare.

SUREPOST^® is a rapid-acting insulin secretagogue that binds to the sulfonylurea receptors in the pancreatic beta cells to stimulate the postprandial insulin secretion rapidly, thereby reducing postprandial blood glucose and lowering HbA1c in type 2 diabetes patients.

SUREPOST^®, which is approved in over 90 countries worldwide, is marketed under the brand name "Prandin" in the United States and "NovoNorm" in European countries. In Japan, DSP took over development of the drug from Novo Nordisk and began clinical studies in 2004.

In clinical studies in patients with type 2 diabetes in Japan, as monotherapy and in combination with alpha-glucosidase inhibitors, SUREPOST^® was found to be an effective and safe drug for reducing excessive postprandial glucose levels and substantially lowering HbA1c.

DSP intends to launch SUREPOST^® after it is listed in the national health insurance drug price listing, and expects that the launch of SUREPOST^® will expand the therapeutic options for patients with type 2 diabetes and contribute to improving the therapy for this disease.

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Profile of "SUREPOST^®"

[Brand Name]	SUREPOST® tablet 0.25 mg SUREPOST® tablet 0.5 mg
[Generic Name]	repaglinide
[Content / Description]	SUREPOST® tablet 0.25 mg: Each tablet contains 0.25 mg of repaglinide SUREPOST® tablet 0.5 mg: Each tablet contains 0.5 mg of repaglinide
[Indication]	The reduction of postprandial blood glucose in patients with type 2 diabetes SUREPOST® is to be used only when adequate effectiveness of either of the following treatments is not obtained: (1) Diet and exercise alone or (2) An alpha glucosidase inhibitor with diet and exercise
[Dose and Administration]	Normally, an adult should begin treatment at 0.25 mg per dose as repaglinide, orally taking this dose just before meals 3 times daily. The maintenance dose is normally 0.25 to 0.5 mg and may be increased or reduced as necessary. The dose may be increased up to 1 mg.
[Manufacturer and Distributor]	Dainippon Sumitomo Pharma Co., Ltd.