Sucampo (SCMP), Takeda Update on AMITIZA in IBS-C Patients; Acceptable Safety, Tolerability Reported
Tweet Send to a FriendGet Alerts SCMP Hot Sheet
Up)
Trade SCMP Now!
A recently published study in the journal Alimentary Pharmacology and Therapeutics, demonstrated the long-term safety and tolerability profiles of AMITIZA (lubiprostone) in patients with irritable bowel syndrome with constipation (IBS-C).
This study, initiated by Takeda Pharmaceuticals U.S.A., Inc. and Sucampo Pharmaceuticals, Inc. (Nasdaq: SCMP), was designed to determine the effects of AMITIZA in patients with IBS-C for up to 52 weeks.
The primary objective of this open-label, extension study (n=520) was to determine the long-term safety and tolerability profiles of AMITIZA when administered twice-daily for 36 weeks (8 mcg twice-daily) to patients with IBS-C. Results indicated that AMITIZA, when administered to IBS-C patients for up to 13 months, continues to demonstrate an acceptable safety and tolerability profile.
“It is important to note that IBS-C is a chronic, long-term condition. Given that AMITIZA is the only drug approved for IBS-C in adult women, it is important to know that it has an established safety and tolerability profile,” said John F. Johanson, MD, MSc, FACP, FACG, Clinical Associate Professor of Medicine, University of Illinois College of Medicine. “Since many of those suffering may be receiving long-term treatment, it is important to have such encouraging data published on the only drug approved for IBS-C in adult women.”
The most common adverse events in this study was diarrhea and nausea (11% each), urinary tract infection and sinusitis (9% each) and abdominal distension (5.8%). There were 11 serious adverse events reported, none of which were considered treatment related. Seventeen patients discontinued for treatment-related adverse events, with diarrhea and nausea accounting for 1.2% (n=6) and 0.6% (n=3) respectively.
In the Amitiza Phase 3 studies, IBS was defined as abdominal pain or discomfort occurring over at least six months with two or more of the following: 1) relieved with defecation; 2) onset associated with a change in stool frequency; and 3) onset associated with a change in stool form. Patients were sub-typed as having IBS-C if they also experienced two of three of the following: 1) less than three spontaneous bowel movements per week, 2) greater than 25% hard stools, and 3) greater than 25% of spontaneous bowel movements associated with straining.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
This study, initiated by Takeda Pharmaceuticals U.S.A., Inc. and Sucampo Pharmaceuticals, Inc. (Nasdaq: SCMP), was designed to determine the effects of AMITIZA in patients with IBS-C for up to 52 weeks.
The primary objective of this open-label, extension study (n=520) was to determine the long-term safety and tolerability profiles of AMITIZA when administered twice-daily for 36 weeks (8 mcg twice-daily) to patients with IBS-C. Results indicated that AMITIZA, when administered to IBS-C patients for up to 13 months, continues to demonstrate an acceptable safety and tolerability profile.
“It is important to note that IBS-C is a chronic, long-term condition. Given that AMITIZA is the only drug approved for IBS-C in adult women, it is important to know that it has an established safety and tolerability profile,” said John F. Johanson, MD, MSc, FACP, FACG, Clinical Associate Professor of Medicine, University of Illinois College of Medicine. “Since many of those suffering may be receiving long-term treatment, it is important to have such encouraging data published on the only drug approved for IBS-C in adult women.”
The most common adverse events in this study was diarrhea and nausea (11% each), urinary tract infection and sinusitis (9% each) and abdominal distension (5.8%). There were 11 serious adverse events reported, none of which were considered treatment related. Seventeen patients discontinued for treatment-related adverse events, with diarrhea and nausea accounting for 1.2% (n=6) and 0.6% (n=3) respectively.
In the Amitiza Phase 3 studies, IBS was defined as abdominal pain or discomfort occurring over at least six months with two or more of the following: 1) relieved with defecation; 2) onset associated with a change in stool frequency; and 3) onset associated with a change in stool form. Patients were sub-typed as having IBS-C if they also experienced two of three of the following: 1) less than three spontaneous bowel movements per week, 2) greater than 25% hard stools, and 3) greater than 25% of spontaneous bowel movements associated with straining.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- Boston Scientific (BSX) Reports Positive Results from NG PROMUS, EVOLVE
- Lloyds Banking (LYG) Sees Meeting Additional PRA Capital Requirements
- Ford Motor (F) Will Ramp Production, Halves Two-Week Plant Idling
Create E-mail Alert Related Categories
Corporate News, FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
