Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that the Company received a supplement approval from the U.S. Food and Drug Administration (FDA) that removes pregnancy "warnings and precautions" and clarifies information regarding the use of AMITIZA® (lubiprostone) by pregnant and/or nursing women. In addition, the FDA expanded the labeling text of the Mechanism of Action section in the prescribing information for AMITIZA. AMITIZA is approved for the treatment of chronic idiopathic constipation (CIC) in adults (24 mcg twice daily) and irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older (8 mcg twice daily).
The Company also announced today that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency's priority review of the supplemental new drug application (sNDA) filing seeking approval for an additional indication for lubiprostone for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. Sucampo was notified that its November 16, 2012 submission of FDA-requested supportive analyses has been designated as a major amendment to the application. Since the receipt date of this additional information is within three months of the PDUFA date, the FDA has decided to extend the goal date by three months to provide time for a full review of the submission. The extended user fee goal date is late April, 2013. No new clinical trials or studies have been requested by the FDA.
"Sucampo's scientific and regulatory teams are pleased with the FDA-approved changes to the AMITIZA label. We believe these changes will enable physicians and women of child-bearing age who are suffering from IBS-C or CIC to better evaluate the risk-benefit profile of AMITIZA. The details added to the mechanism of action section highlight AMITIZA's ability to restore the mucosal barrier of the gut, which is important to further clarify clinician understanding of how AMITIZA may work in the treatment of IBS-C. Additionally, we look forward to completion of the FDA's review of our sNDA for OIC," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo.
Sucampo has accepted the following FDA-approved labeling changes, which will be effective immediately: