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Sucampo Announces FDA Approval Of An SNDA For RESCULA® (unoprostone Isopropyl)

Adverse reactions

In clinical studies, ocular adverse events above 5% with use of RESCULA were burning/stinging (22.4%), burning/stinging upon drug instillation (18.6%), itching (13.2%), injection (11.6%), dry eyes (10.7%), foreign body sensation (9.0%), abnormal vision (8.2%), lacrimation disorder (6.2%) and eyelid disorder (5.8%). Approximately 10-14% of patients were observed to have an increase in the length of eyelashes (≥ 1mm) at 12 months, while 7% of patients were observed to have a decrease in the length of eyelashes. Corneal lesions were reported in 2.3% of patients.

The most frequently reported nonocular adverse event associated with the use of RESCULA in the clinical trials was flu-like syndrome, observed in approximately 6% of patients.

Use in specific populations

Pregnancy Category C - There are no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, RESCULA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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.

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