Sucampo Wins Approval for Expanded Use of Amitiza in U.S.

Sucampo Pharmaceuticals Inc. won approval to expand the use of its Amitiza drug to treat opioid-induced constipation in patients with chronic non-cancer pain. The approval spurred the company’s shares to the greatest one-day gain in more than four years.

The Food and Drug Administration cleared the medicine, already backed in 2006 for certain types of constipation. Sucampo, based in Bethesda, Maryland, has a partnership with Osaka, Japan-based Takeda Pharmaceutical Co. to sell Amitiza in the U.S.

Amitiza is the first oral prescription medication available for opioid-induced constipation, the companies said in a statement today. Use of the drug for the condition will create a peak market opportunity of $200 million, Irina Rivkind, an analyst with Cantor Fitzgerald LP in New York, said in a note to clients. Sucampo reported sales of $81.5 million last year, according to data compiled by Bloomberg.

Opioid-induced constipation is experienced by about 40 percent of patients on the painkillers, according to an article published in The American Journal of Gastroenterology in May


Sucampo gained 24 percent to $8.46 at the close in New York, the biggest single-day increase since December 2008. The company is eligible for a $10 million payment from Takeda when sales of the treatment begin and $50 million in commercial milestone payments, Rivkind said.

Cubist, Nektar

Cubist Pharmaceuticals Inc. is studying bevenopran, a pill that would treat opioid-induced constipation in patients with chronic, non-cancer pain. Nektar Therapeutics and AstraZeneca Plc are studying a tablet that would combine experimental naloxegol with certain opioids to treat pain without constipation.

Salix Pharmaceuticals Ltd.’s Relistor was approved in 2008 as an injection to help treat opioid-induced constipation in patients with advanced illnesses who are receiving care to relieve suffering. The company attempted to expand Relistor into patients with chronic, non-cancer pain taking opioids and was rejected by the FDA in July.

Salix is weighing whether it will seek approval for the active ingredient in Relistor, methylnaltrexone, as an oral treatment for the condition, the company said in its 2012 annual report.

FDA Delay

The FDA delayed the decision to expand use of Amitiza in November to review analysis submitted that month, Sucampo said on Nov. 30. At the time, Sucampo said the FDA did approve label changes that removed all pregnancy-related warnings and precautions.

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.

Sucampo receives a tiered royalty rate of 18 percent to 26 percent on Amitiza, Rivkind said. The twice-daily drug is approved for constipation in adults for which the cause is unknown, meaning there isn’t an underlying illness or medication at the root of the condition and to treat irritable bowel syndrome with constipation in adult women.

Sucampo is studying Amitiza in pediatric constipation.

Before it's here, it's on the Bloomberg Terminal.