Pediatric Use - the safety and efficacy of RESCULA in pediatric patients have not been established.
It is not known whether RESCULA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when RESCULA is administered to a nursing woman.
No overall differences in safety or effectiveness of RESCULA have been observed between elderly and other adult populations.
About Sucampo Pharmaceuticals, Inc.Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on innovative research, discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman, Chief Executive Officer, Chief Scientific Officer, and co-founder. Prostones, naturally occurring fatty acid metabolites that have emerged as promising compounds with unique physiological activities, can be targeted for the treatment of unmet or underserved medical needs. For more information, please visit www.sucampo.com. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG. About R-Tech Ueno, Ltd. R-Tech Ueno is a publicly traded company listed on the JASDAQ exchange. It is a bio venture company established in September 1989 for the purpose of R&D and marketing of drugs. Under the leadership of CEO Yukihiko Mashima, M.D., Ph.D., also a medical doctor, the company is developing new drugs on the theme “Physician-Oriented New Drug Innovation,” targeting ophthalmologic and dermatologic diseases that previously had no effective therapeutic agent. We aim at becoming a “global pharmaceutical company specializing in specific fields (ophthalmology and dermatology) and developing and selling pharmaceutical products through the eyes of doctors. We are promoting the development of new drugs for unmet medical needs for which the government provides recommendations and assistance, orphan drugs and the drugs in the field of anti-aging (lifestyle drugs). Sucampo Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, future financial and operating results, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo's ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the US and internationally and the exposure to litigation and/or regulatory actions.