Sucampo Pharmaceuticals Inc. recently attained Food and Drug Administration (FDA) acceptance of its supplemental new drug application (sNDA) for Amitiza (lubiprostone), a product designed to address pediatric functional constipation.
In addition, the application was granted priority review status, which means that the medication may provide a potential breakthrough in treatment for its targeted condition, accelerating the timeline for approval, according to a press release. The FDA set a user fee goal date of Jan. 28.
“We are pleased with the FDA’s acceptance of the sNDA filing with Priority Review, as this underscores the need for prescription options for children 6 to 17 years of age suffering from pediatric functional constipation,” Peter Greenleaf, Sucampo’s chairman and CEO, said in the release. “If approved, AMITIZA would be the first and only prescription medication specifically for these pediatric patients, who currently have limited options to address their underlying functional constipation.”
The drug works by increasing fluid production in the small intestine, facilitating elimination and mitigating constipation symptoms. It has already been approved for adults with certain types of constipation or irritable bowel syndrome, the release said.
Based in Rockville, Maryland, Sucampo specializes in development and commercialization of product candidates for orphan diseases and genetic disorders.