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Sucampo Pharma Europe, Ltd, a wholly-owned subsidiary of Sucampo Pharmaceuticals, Inc, has announced the filing of a Marketing Authorisation Application (MAA) for lubiprostone in the UK.
The MAA is for lubiprostone, 24 mcg, for the indication of chronic idiopathic constipation in adults.
Lubiprostone was previously developed by Sucampo Pharmaceuticals, Inc. for the treatment of chronic idiopathic constipation in adults in the US.
Using the decentralised procedure, the UK, through its Medicines and Healthcare Products Regulatory Agency, will serve as the reference member state with additional applications being filed with the concerned member states of Belgium, Denmark, France, Germany, Ireland, the Netherlands, Spain and Sweden.
Individuals with chronic idiopathic constipation are distinguished as having abdominal bloating, infrequent bowel movement, straining at defecation, hard or lumpy stools for at least three months and not having these symptoms caused by other diseases or medication usage.
Lubiprostone, 24 mcg, approved in the US in January 2006 under the trade name Amitiza®, has been shown in clinical studies to provide a rapid and sustained relief of chronic idiopathic constipation and the associated symptoms.
Lubiprostone, through a novel mechanism of action, selectively activates type-2 chloride channels in the intestinal lumen, which facilitates intestinal fluid secretion that enhances intestinal motility and passage of stool. Additionally, lubiprostone has been shown in ex-vivo studies by the activation of chloride channels to stimulate recovery of mucosal barrier function through the restoration of tight junction complexes.
Lubiprostone has demonstrated long-term safety and efficacy for treatment of chronic idiopathic constipation for up to one year. Furthermore, lubiprostone demonstrated efficacy in all adults of both genders including those over 65 years of age.
“The lack of effective prescription products for this indication provides a unique opportunity for Sucampo to introduce lubiprostone to Europe as a treatment for chronic idiopathic constipation,†said Sucampo Pharmaceuticals Chairman and Chief Executive Officer Ryuji Ueno, MD, PhD, PhD. “The filing of the application for lubiprostone represents one step in Sucampo’s planned expansion for this compound to the international community.â€
Other than the US and Canada, Sucampo Pharmaceuticals retains all commercial rights for lubiprostone for Europe and the rest of the world. Sucampo Pharmaceuticals’ drug Amitiza (lubiprostone) was a 2006 Scrip Awards finalist for the “Best New Small-Molecule Drug†category.
