Salix Pharmaceuticals receives FDA approval for Xifaxan 550 mg to treat IBS-D in adults

In continuation of my update on xifaxan

Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for Xifaxan® 550 mg for the treatment of IBS-D in adults. The FDA approval of Xifaxan 550 mg is based on data from three phase 3 studies, TARGET 1, TARGET 2 and TARGET 3. Xifaxan 550 mg was studied in over 3,000 patients and demonstrated the efficacy and safety of repeat treatment following completion of a two-week course of treatment. A full course of Xifaxan 550 mg for IBS-D is available in a convenient 2 week pack of 42 pills.

"As a gastroenterologist who helps patients navigate the symptoms of IBS-D, I see the need for treatments that directly address those most bothersome, such as diarrhea and abdominal pain" said Dr. Mark Pimentel, director of the Gastrointestinal Motility Program and Laboratory at Cedars-Sinai in Los Angeles. "Today's approval gives a new option to these patients and providers."

Salix Pharmaceuticals receives FDA approval for Xifaxan 550 mg to treat IBS-D in adults

Positive results from phase 3 clinical trials of Linoclotide ....

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. recently announced positive top‐line results from two Phase 3 clinical trials assessing the safety and efficacy of once‐daily dosing of the investigational drug linaclotide in patients with chronic constipation (CC). Analyses of the data indicate that in both multicenter, randomized, double‐blind, placebo‐controlled trials, statistical significance was achieved for the primary endpoint of 12‐week complete spontaneous bowel movement (CSBM) overall responder at the two doses studied in each trial (133 mcg/day: p‐values≤0.0012 and 266 mcg/day: p‐values<0.0001). In both trials, statistical significance (p<0.01) was achieved for all prespecified secondary endpoints, which included measures of bloating, abdominal discomfort, and average weekly CSBMs.

About Linaclotide :

Linaclotide (see the structure) is an orally delivered peptide that acts locally in the gut with no detectable systemic exposure at therapeutic doses and is intended for once‐daily administration. Linaclotide can be synthesized by solid-phase technology using Fmoc protections. Amino acids are coupled using DCC/HOBT and Fmoc groups are removed by means piperidne .Cysteinethiol groups are protected with trityl and cleavage of the peptide from the resin is done by TFA.

Mode of action :

Linoclotide acts agonist of guanylate cyclase type‐C (GC‐C), a receptor found on the lining of the intestine. Activation of GC‐C leads to increases in intracellular and extracellular cGMP. In preclinical models, extracellular cGMP inhibited afferent nerve firing and positively affected markers of abdominal pain, while intracellular cGMP led to activation of anion channels which stimulated anion and fluid secretion into the intestine, leading to accelerated intestinal transit. Linaclotide is a first‐in‐class compound in Phase 3 clinical development for the treatment of IBS‐C and CC.

Ref : http://www.ironwoodpharma.com/newsPDF/Linaclotide.Ph3.CC.results.11.02.09.pdf