Sucampo Announces FDA Approval of an sNDA for RESCULA® (unoprostone isopropyl)
Dec 12th 2012 7:05AM
Updated Dec 12th 2012 7:10AM
Sucampo Announces FDA Approval of an sNDA for RESCULA® (unoprostone isopropyl)
Sucampo Will Begin Commercializing RESCULA in First Quarter of 2013
BETHESDA, Md.--(BUSINESS WIRE)-- Sucampo Pharmaceuticals, Inc. ("Sucampo" or "the Company") (NAS: SCMP) today announced that it has received approval of an sNDA for RESCULA® (unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension from the U.S. Food and Drug Administration (FDA). Open-angle glaucoma is the most common form of glaucoma. Sucampo intends to commercialize RESCULA in the first quarter of 2013.
According to the approved product labeling, RESCULA may be used as a first-line agent or concomitantly with other topical ophthalmic drug products to lower intraocular pressure. RESCULA is a BK (Big Potassium) channel activator, which is different from other IOP lowering agents.
"RESCULA provides IOP reduction by increasing trabecular flow, and may be an appropriate choice for eye specialists who are trying to balance efficacy with management of side effects. It has been shown to be an effective medicine in lowering IOP in patients with open-angle glaucoma and ocular hypertension while demonstrating an excellent systemic safety profile and an established ocular side effects profile," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific Officer of Sucampo.
About Unoprostone Isopropyl (RESCULA)
Unoprostone isopropyl is a member of Sucampo's family of prostones and is a synthetic docosanoid. Unoprostone isopropyl may have a local effect on BK (Big Potassium) channels in the eye. BK channels are expressed in contractile tissues like the trabecular meshwork. RESCULA may reduce elevated intraocular pressure (IOP) by increasing the outflow of aqueous humor through the trabecular meshwork. Complete details of the mechanism of action are unknown at this time.
RESCULA was originally approved by the FDA in 2000 for the lowering of IOP in open-angle glaucoma and ocular hypertension in patients who are intolerant of or insufficiently responsive to other IOP lowering medications. In April 2009, Sucampo acquired the commercialization rights to RESCULA for the United States and Canada from R-Tech Ueno, Ltd. (RTU).
Important Safety Information
RESCULA is contraindicated in patients with hypersensitivity to unoprostone isopropyl or any other ingredient in this product.
Warnings and precautions
Unoprostone isopropyl ophthalmic solution may gradually increase the pigmentation of the iris. The pigmentation change is believed to be due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long term effects of increased pigmentation are not known. Iris color changes seen with administration of unoprostone isopropyl ophthalmic solution may not be noticeable for several months to years. Treatment with RESCULA solution can be continued in patients who develop noticeably increased iris pigmentation. Patients who receive treatment with RESCULA should be informed of the possibility of increased pigmentation which is likely to be permanent.
Unoprostone isopropyl has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as unoprostone isopropyl is administered, but has been reported to be reversible upon discontinuation of unoprostone isopropyl ophthalmic solution in most patients.
RESCULA should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Macular edema, including cystoid macular edema, has been reported. RESCULA should be used with caution in aphakic patients, in pseudoaphakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip. Keep bottle tightly closed when not in use. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.
RESCULA contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.
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.
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.
No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect Sucampo's business, particularly those mentioned in the risk factors and cautionary statements in Sucampo's Form 10-K for the year ended Dec. 31, 2011, which the Company incorporates by reference.
Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
KEYWORDS: United States North America Maryland
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