Sucampo Pharmaceuticals submits supplemental new drug application for Lubiprostone to treat IBS-C

Sucampo Pharmaceuticals, Inc., (Sucampo Pharmaceuticals) today announced that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration to seek market approval of a lower strength of lubiprostone (8 mcg) to treat irritable bowel syndrome with constipation (IBS-C). Lubiprostone, developed by Sucampo Pharmaceuticals, is currently approved for the treatment of Chronic Idiopathic Constipation in adults as AMITIZA (24 mcg) and is marketed by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America, Inc., (Takeda) in the U.S. for that indication.

IBS-C has a significant impact on millions of Americans living with the condition, said Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals founder, chairman and chief executive officer. We are excited that the results of our clinical studies have led to the successful filing of a supplemental New Drug Application for a lower strength of lubiprostone [8 mcg, twice daily] for IBS-C. If approved, lubiprostone may offer a new treatment option for people living with this condition.

Approximately 58 million Americans have irritable bowel syndrome, with IBS-C accounting for approximately one-third of these cases. IBS-C symptoms include abdominal pain and discomfort associated with defecation or a change in bowel habits with features of disordered defecation.

The supplemental application is based on a clinical study program that included two Phase III, multi-center, double-blinded, randomized, placebo-controlled trials involving 1,171 adults, followed by one long-term, open-label safety and efficacy extension trial involving 522 adults diagnosed with IBS-C. In the two Phase III studies, patients received lubiprostone 8 mcg taken twice daily (783 adults) or placebo (388 adults) over a 12-week period. In both trials, patients receiving lubiprostone 8 mcg twice daily were nearly twice as likely to achieve an overall response that was statistica

Contact: Stephanie Donlan

Page: 1 2

Related medicine news :

1. Sucampo submits new drug application for lubiprostone
2. American Urological Association honors Novartis Pharmaceuticals with annual health science award
3. Takeda submits new drug application for extended-release type 2 diabetes medication, ACTOplus met
4. Takeda submits new drug application for combination type 2 diabetes medication
5. Penn critical-care physicians recommend strategies when facing requests to end supplemental oxygen
6. Patients receiving supplemental oxygen during surgery have reduced risk of wound infection
7. Brightening prospects of using fluorescent nanotubes in medical applications
8. Panbio files first patent application for Homogenous Assay Technology
9. LOral accepting applications for 2007 USA fellowships for Women in Science
10. NIH wrongly blamed for reduced success rate of grant applications
11. Magnet lab researcher exploring science behind commercial applications of liquid helium

Post Your Comments:

(Date:3/26/2019)... ... 25, 2019 , ... Cardea Bio , leading manufacturer ... new CRISPR-Chip which has the potential to detect genetic mutations within ... which enables Nanosens to build breakthrough science on top of Cardea’s IP-protected graphene ...
(Date:3/25/2019)... ... 2019 , ... Auberge du Soleil , Napa Valley’s quintessential adult getaway, ... signature wellness tea blend available exclusively for guests of the award-winning Auberge du Soleil ... spearmint. The Auberge du Soleil + ERDA Spa Tea is now being served at ...
(Date:3/25/2019)... ... , ... As part of its rapid expansion into new territory ... new specialist and pain clinic in South Florida. , Man Q. Le, M.D., has ... location: 9970 Central Park Blvd., N, Suite 401, Boca Raton, FL 33428. , ...
(Date:3/23/2019)... ... 23, 2019 , ... Highway West Vacations has announced its first annual Borrego ... guided mindfulness and hiking in the blooming California desert, learn healthy cooking behavior, and ... and unwinding next to the Anza-Borrego Desert State Park at Palm Canyon Hotel & ...
(Date:3/23/2019)... ... March 22, 2019 , ... ... lifestyle solutions, is celebrating 17 years of business and transformed lives with the ... Puerto Rico, and Canada while supplies last, the meal replacement protein shake features ...
Breaking Medicine News(10 mins):
(Date:3/26/2019)... Fla. (PRWEB) , ... March 26, 2019 , ... ... today announced that West Penn Hospital, part of Pittsburgh-based Allegheny Health Network (AHN), ... ill infants in its Level III Neonatal Intensive Care Unit (NICU), including a ...
(Date:3/26/2019)... SAN FRANCISCO (PRWEB) , ... March 26, 2019 ... ... and software products for the life sciences industry, is pleased to announce plans ... goal of Innovation Nation is to keep life sciences companies on the cutting ...
(Date:3/25/2019)... ... , ... A March 1 article on CBS News reports an uptick in millennials ... an effort to stand out in a competitive job market. The article noted that some ... advantage possible in the workforce against their peers, as well as older job seekers. While ...
Breaking Medicine Technology:
Cached News: