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News Breaks
June 12, 2014
14:44 EDTSCMPSucampo issues statement regarding AADPA meeting's vote
Sucampo Pharmaceuticals issued the following statement regarding the Anesthetic and Analgesic Drug Products Advisory Committee meeting's vote: "As a chloride channel activator, AMITIZA has a different mechanism of action than the peripherally acting mu-opioid receptor antagonists and is approved by the U.S.FDA to treat opioid induced constipation. AMITIZA has been prescribed over eight million times over more than eight years and has a well-tolerated safety profile, with no cardiovascular precautions or warnings. FDA did not require Sucampo to reevaluate our clinical data for cardiovascular risks, as they did for the PAMORAS, and AMITIZA was therefore not a participant in this week's Advisory Committee," said Peter Greenleaf, CEO of Sucampo. "We believe the outcome of today's Advisory Committee further demonstrates the FDA's awareness that safety, specifically the potential cardiovascular safety associated with the PAMORAS class of compounds, is paramount in assessing alternative therapies for OIC, which is a severe condition that affects 40-80 percent of the estimated 250 million patients who receive prescriptions for opioids each year for non-cancer pain. OIC is still widely under-identified and under-managed, and we believe that potential new entrants to the market can help increase overall awareness of the condition. We remain committed to maximizing AMITIZA's potential and to bringing it to physicians and patients worldwide for the treatment of OIC."
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July 25, 2014
16:45 EDTSCMPS&R Foundation reports 6.3% stake in Sucampo
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July 23, 2014
06:51 EDTSCMPSucampo announces publication of NICE recommendatoin for Amitiza
Sucampo announced that the United Kingdom's National Institute of Health and Care Excellence has published the technology appraisal guidance recommending the use of AMITIZA in the treatment of chronic idiopathic constipation and associated symptoms in adults who have failed laxatives. The NICE guidance recommends AMITIZA as an option for treating CIC for adults in whom treatment with at least 2 laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and for whom invasive treatment for constipation is being considered.
July 22, 2014
15:12 EDTSCMPSucampo says FDA approves addition of Nitto Medic as Rescula production site
Sucampo Pharmaceuticals disclosed in a regulatory filing that on July 15 the company received an approval letter from the FDA to its prior approval supplement in response to FDAs review of the revised Drug Master File of R-Tech Ueno. The approval provides for the addition of Nitto Medic of Toyama, Japan as a new production site for Rescula 0.15%. "The company has adequate supply of RESCULA to be able to supply the U.S. market into the first quarter of 2015," Sucampo added.

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