Sucampo: UK Regulators Refuse To Grant Type II Variation For AMITIZA For OIC

(RTTNews) - Sucampo Pharmaceuticals, Inc. (SCMP) late Wednesday announced that its unit Sucampo Pharma Europe, Ltd. has received a notice of refusal to grant a Type II variation for AMITIZA (lubiprostone) 24 mcg for opioid- induced constipation or OIC from the Medicines and Healthcare Products Regulatory Agency or MHRA in the UK. Sucampo said it will evaluate all options for path forward.

It was in 2013 that Sucampo completed a Type II variation submission to update the Summary of Product Characteristics for AMITIZA in the U.K. to include the additional therapeutic indication of OIC in non-cancer pain.

The company noted that 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.

In 2012, the MHRA approved AMITIZA for the treatment of chronic idiopathic constipation or CIC and associated symptoms in adults when response to diet and other non-pharmacological measures are inappropriate.

Sucampo now said it is reviewing the variation assessment report or VAR from the MHRA and intends to explore all available options for a path forward.

In 2013, the 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.

Peter Greenleaf, Sucampo's Chief Executive Officer, said, "While we are disappointed with the MHRA decision, we believe in the potential of AMITIZA to meet the unmet medical needs of OIC patients. ….. 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."