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Sucampo Pharmaceuticals, Inc.
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 has accepted the following FDA-approved labeling changes, which will
be effective immediately:
1. 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.”
2. 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.
3. 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.”
4. The Mechanism of Action section (Section 12.1) of the label now reads as
follows: “Lubiprostone is a locally acting chloride channel
activator…activation of ClC-2 by lubiprostone has been shown to stimulate
recovery of mucosal barrier function and reduce intestinal permeability
(bolding added to indicate label addition) via the restoration of tight
junction complexes in ex vivo studies of ischemic porcine intestine.”
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