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.
Sucampo completed in 2013 a Type II variation submission to update the Summary of Product Characteristics (SPC) for AMITIZA in the U.K. to include the additional therapeutic indication of OIC in non-cancer pain. MHRA is of the opinion that insufficient evidence of efficacy for the proposed OIC indication had been presented. The MHRA stated in the VAR that the safety profile of lubiprostone appears consistent with what is currently described in the SPC for the approved indication in CIC.
"While we are disappointed with the MHRA decision, we believe in the potential of AMITIZA to meet the unmet medical needs of OIC patients," said Peter Greenleaf, Sucampo's Chief Executive Officer. "AMITIZA is an important treatment option for patients on three continents, with more than 8 million patients treated in its 8 years on the market. Backed by the approval of AMITIZA for OIC in the United States in 2013, we remain fully committed to making AMITIZA available for additional indications in the U.K. and in other geographic markets around the world. Sucampo intends to work closely with the MHRA to determine our path forward."