Lubiprostone News and Research

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Synthetic Biologics announces initiation of SYN-010 Phase 2 clinical trial for treatment of IBS-C

Synthetic Biologics, Inc., a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, reported the initiation of a Phase 2 clinical trial of its proprietary SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C).

29 Jun 2015

New AGA guidelines provide guidance on IBS treatments

Up to 15 percent of the general adult population is affected by irritable bowel syndrome (IBS), and most patients struggle to find effective drug therapy. A new guideline from the American Gastroenterological Association provides these patients and their physician's guidance.

6 Nov 2014

Sucampo's supplemental new drug application for AMITIZA gets FDA approval

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. announced today that the United States Food and Drug Administration has approved Sucampo's supplemental new drug application for AMITIZA (lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain.

24 Apr 2013

Sucampo, R-Tech Ueno and Takeda file patent infringement lawsuit against Anchen for AMITIZA

Sucampo Pharmaceuticals, Inc. announced that it, together with R-Tech Ueno, Ltd., Sucampo AG, and Takeda Pharmaceutical Company Limited and certain affiliates of Takeda, has filed a patent infringement lawsuit against Anchen Pharmaceuticals, Inc., which had filed Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) to market a generic version of AMITIZA (lubiprostone) oral capsules, and certain affiliates of Anchen.

12 Feb 2013

Sucampo receives supplement approval from FDA for AMITIZA

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.

30 Nov 2012

AMITIZA for treatment of chronic constipation now available in Japan

Sucampo Pharmaceuticals, Inc. and Abbott today announced the availability of AMITIZA (lubiprostone) in Japan, a prescription medicine for the treatment of chronic constipation not caused by organic diseases. AMITIZA was approved by the Ministry of Health, Labor and Welfare (MHLW) in Japan in June.

26 Nov 2012

MHRA approves Sucampo’s AMITIZA to treat chronic idiopathic constipation in the U.K.

Sucampo Pharmaceuticals, Inc. today announced that it has received approval from the Medicines and Healthcare products Regulatory Agency for AMITIZA (lubiprostone) 24 mcg twice daily for the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g., educational measures, physical activity) are inappropriate.

12 Sep 2012

Takeda, Sucampo file AMITIZA sNDA with FDA for treatment of opioid-induced constipation

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A. Inc. today announced the filing of a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for a new indication for AMITIZA (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

26 Jul 2012

Abbott, Sucampo receive Japanese approval for AMITIZA

Sucampo Pharmaceuticals, Inc. and Abbott today announced that Sucampo Pharma, Ltd., a wholly owned subsidiary of SPI, has received approval from the Ministry of Health, Labor and Welfare in Japan for AMITIZA (lubiprostone), a prescription medicine for the treatment of chronic constipation.

5 Jul 2012

Sucampo announces positive results from lubiprostone phase 3 trial on OBD

Sucampo Pharmaceuticals, Inc. today announced positive top-line results from an open-label phase 3 clinical trial designed to evaluate the long-term safety and efficacy of lubiprostone in opioid-induced bowel dysfunction (OBD) patients with chronic, non-cancer-related pain.

6 Apr 2012

Rifaximin and lubiprostone offer best options for patients with IBS

Cedars-Sinai researchers have determined that two prevalent drug therapies - rifaximin and lubiprostone - offer some of the best options for treating irritable bowel syndrome, a widespread disorder that affects up to one in five Americans.

26 Mar 2012

Takeda, SPI announce that lubiprostone phase 3 trial on OBD meets primary endpoint

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. announced today that lubiprostone met the primary endpoint in a phase 3 clinical trial for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.

2 Feb 2012

Abbott, Sucampo present lubiprostone phase 3 trial data in Japanese CIC at DDW 2011

Sucampo Pharmaceuticals, Inc. and Abbott today reported data from a phase 3 clinical efficacy trial in 124 Japanese chronic idiopathic constipation patients as well as from a phase 3 long-term safety trial in an additional 209 Japanese CIC patients.

10 May 2011

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. today announced the dosing of the first patient in the third phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of spontaneous bowel movements (SBMs).

7 Jan 2011

Long-term phase 3 trial confirms safety of lubiprostone in Japanese patients with chronic idiopathic constipation

Sucampo Pharmaceuticals, Inc. and Abbott today announced positive top-line data from a 48-week phase 3 long-term safety and efficacy clinical trial of lubiprostone in Japanese patients with chronic idiopathic constipation (CIC). The trial demonstrated that lubiprostone was safe and well-tolerated.

30 Nov 2010

Sucampo submits marketing application for Amitiza drug

Sucampo Pharmaceuticals, Inc. and Abbott today announced that Sucampo Pharma Ltd., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc., has submitted a marketing application to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market Amitiza (lubiprostone) 24 mcg for the treatment of chronic idiopathic constipation (CIC).

7 Oct 2010

Ironwood, Forest Laboratories announce positive results for linaclotide Phase 3 clinical trials in IBS-C patients

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from the first of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with constipation (IBS-C).

14 Sep 2010

Sucampo Pharmaceuticals second-quarter 2010 total revenue declines to $13.8 million

Sucampo Pharmaceuticals, Inc. today reported its consolidated financial results for the quarter and six months ended June 30, 2010.

7 Aug 2010

Sucampo announces completion of lubiprostone phase 3 trial for CIC in Japanese patients

Sucampo Pharmaceuticals, Inc. announced that phase 3 double blind trial of lubiprostone (marketed as AMITIZA (R) in the U.S.) for chronic idiopathic constipation in Japanese patients has been completed.

10 Jun 2010

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Sucampo Pharmaceuticals, Inc. and Abbott today announced that a pivotal phase 3 clinical trial of lubiprostone for chronic idiopathic constipation (CIC) in Japanese patients met its primary endpoint with statistical significance and demonstrated a safety profile consistent with previously reported clinical lubiprostone data.

9 Jun 2010