Sucampo Pharmaceuticals, Inc. (SCMP) announced that it received a supplement approval from the U.S. Food and Drug Administration or 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 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 said it has accepted the following FDA-approved labeling changes, which will be effective immediately.
All pregnancy-related Warnings and Precautions (Section 5.1 of the label) have been removed. This includes deletion of the sentence: "Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures."
Section 8 of the product labeling, "Use in Specific Populations," was updated to include additional animal data and a Clinical Consideration section, with the pregnancy category remaining unchanged.
Previous labeling statements regarding the potential for serious adverse reactions in nursing infants have been removed. The revised label states that caution should be exercised when AMITIZA is administered to a nursing mother and advises "lactating women to monitor their human milk-fed infants for diarrhea while taking AMITIZA."
For comments and feedback: editorial@rttnews.com