Sucampo Pharmaceuticals, Inc. (SCMP) Receives Notice That Second Indication For AMITIZA For Opioid-Induced Constipation Is Not Approved By Medicines And Healthcare Products Regulatory Agency In U.K.
3/13/2014 9:23:28 AM
BETHESDA, Md., March 12, 2014 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP) today announced that Sucampo Pharma Europe, Ltd., its wholly owned subsidiary, has received a notice of refusal to grant a Type II variation for AMITIZA® (lubiprostone) 24 mcg for opioid- induced constipation (OIC) from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (U.K.). In 2012, the MHRA approved AMITIZA for the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults when response to diet and other non-pharmacological measures (e.g., educational measures, physical activity) are inappropriate. In 2013, the United States (U.S.) Food and Drug Administration approved AMITIZA as the first and only oral medication for the treatment of OIC in adult patients with chronic, non-cancer pain. Sucampo is reviewing the variation assessment report (VAR) from the MHRA and intends to explore all available options for a path forward.
Help employers find you! Check out all the jobs and post your resume.
comments powered by