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Sucampo Drops After FDA Delays Amitiza Decision

Sucampo Pharmaceuticals Inc. fell the most in five months after U.S. regulators delayed a decision on expanding the use of its Amitiza drug to treat opioid-induced constipation in patients with chronic, non-cancer pain.

Sucampo declined 8 percent to $4.82 at 4 p.m. New York time, its biggest decline since July 6. The shares of the Bethesda, Maryland-based company have gained 8.8 percent this year.

The Food and Drug Administration extended Sucampo’s decision date three months to late April because the agency needed more time to review data analysis submitted Nov. 16, Sucampo said in a statement on Nov. 30. Twice-daily Amitiza, first approved in 2006, is the company’s sole product on the market.

The FDA did approve label changes for Amitiza that removed all pregnancy-related warnings and precautions, the company said. The changes include the deletion of the caution that women who could become pregnant should have a negative pregnancy test prior to beginning the treatment and should be capable of using effective contraception. The new label advises nursing mothers to monitor their infants for diarrhea while taking Amitiza.

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