FDA News

FDA approves Trulance for IBS-C

William D. Chey, MD
William D. Chey

Synergy Pharmaceuticals announced the FDA has approved Trulance for the treatment of constipation-predominant irritable bowel syndrome in adults.

This is the second indication for Trulance (plecanatide), which the FDA first approved for chronic idiopathic constipation (CIC) in January 2017.

“Approximately 1 in 20 Americans are living with IBS-C, many of whom are not satisfied with currently available treatment options,” William D. Chey, MD, professor of medicine, director of the GI Physiology Laboratory, and co-director of the Michigan Bowel Control Program at the University of Michigan, said in a press release. “With this second indication for Trulance, patients and physicians will have a much-needed, new treatment option with an established safety profile that can effectively address abdominal pain and constipation experienced by patients with IBS-C.”

The drug received approval for use at a 3-mg dose, taken orally once a day with or without food, and works in the upper GI tract by mimicking the endogenous human GI peptide uroguanylin to improve bowel function.

The approval is supported by data from two phase 3 randomized controlled trials involving more than 2,100 patients with IBS-C who were treated with plecanatide. In both trials, significantly more patients achieved the primary endpoint (30% reduction in worst abdominal pain and an increase of 1 complete spontaneous bowel movement (CSBM) vs. baseline, in the same week, for at least half of the 12 treatment weeks) with plecanatide vs. placebo (30.2% vs. 17.8%; P < .001 and 21.5% vs. 14.2%; P = .009).

Patients treated with the study drug also achieved significant reductions in abdominal pain and improved stool frequency, stool consistency, and straining with bowel movements compared with placebo. Diarrhea was the most common adverse event (4.3% vs. 1% with placebo), with 1% of patients reporting severe diarrhea. Discontinuation rates were low (2.5% vs. 0.4% with placebo), and diarrhea was the most common adverse reaction attributed to discontinuation (1.2% vs. 0% with placebo).

The post-marketing diarrhea rate is less than 0.5%, and there have been no reports of severe diarrhea requiring hospitalization since it was launched for CIC, the press release noted.

“The qualitative and quantitative feedback we’ve received from physicians and patients has been very positive,” Troy Hamilton, CEO of Synergy Pharmaceuticals, told Healio Gastroenterology and Liver Disease. “To date, when you look at the real world patient experience, it really has supported the clinical trial data. Both from an efficacy and tolerability perspective, what we’ve seen in our clinical trials seems to be playing out in the marketplace, which is very positive for the health care professionals, but also the patients.”

Hamilton noted that in addition to maximizing the value of Trulance, the company will potentially consider pursuing an indication of opioid-induced constipation in the future.

“But right now, we’re focused on building demand not only in CIC, but continuing that momentum with the IBS-C indication,” he said. “We feel very strongly about our label because of the pharmacology — we are the first and only analog of uroguanylin — and also the ease of use — we have one 3-mg once-daily dose approved for both indications. Trulance is the only prescription medication for adults with CIC and now IBS-C that can be taken once-daily, at any time of day with or without food, so patients don’t have to plan their day around their medication.” – by Adam Leitenberger

Disclosures: Hamilton is employed by Synergy, and Chey reports a financial relationship with Synergy.

William D. Chey, MD
William D. Chey

Synergy Pharmaceuticals announced the FDA has approved Trulance for the treatment of constipation-predominant irritable bowel syndrome in adults.

This is the second indication for Trulance (plecanatide), which the FDA first approved for chronic idiopathic constipation (CIC) in January 2017.

“Approximately 1 in 20 Americans are living with IBS-C, many of whom are not satisfied with currently available treatment options,” William D. Chey, MD, professor of medicine, director of the GI Physiology Laboratory, and co-director of the Michigan Bowel Control Program at the University of Michigan, said in a press release. “With this second indication for Trulance, patients and physicians will have a much-needed, new treatment option with an established safety profile that can effectively address abdominal pain and constipation experienced by patients with IBS-C.”

The drug received approval for use at a 3-mg dose, taken orally once a day with or without food, and works in the upper GI tract by mimicking the endogenous human GI peptide uroguanylin to improve bowel function.

The approval is supported by data from two phase 3 randomized controlled trials involving more than 2,100 patients with IBS-C who were treated with plecanatide. In both trials, significantly more patients achieved the primary endpoint (30% reduction in worst abdominal pain and an increase of 1 complete spontaneous bowel movement (CSBM) vs. baseline, in the same week, for at least half of the 12 treatment weeks) with plecanatide vs. placebo (30.2% vs. 17.8%; P < .001 and 21.5% vs. 14.2%; P = .009).

Patients treated with the study drug also achieved significant reductions in abdominal pain and improved stool frequency, stool consistency, and straining with bowel movements compared with placebo. Diarrhea was the most common adverse event (4.3% vs. 1% with placebo), with 1% of patients reporting severe diarrhea. Discontinuation rates were low (2.5% vs. 0.4% with placebo), and diarrhea was the most common adverse reaction attributed to discontinuation (1.2% vs. 0% with placebo).

The post-marketing diarrhea rate is less than 0.5%, and there have been no reports of severe diarrhea requiring hospitalization since it was launched for CIC, the press release noted.

“The qualitative and quantitative feedback we’ve received from physicians and patients has been very positive,” Troy Hamilton, CEO of Synergy Pharmaceuticals, told Healio Gastroenterology and Liver Disease. “To date, when you look at the real world patient experience, it really has supported the clinical trial data. Both from an efficacy and tolerability perspective, what we’ve seen in our clinical trials seems to be playing out in the marketplace, which is very positive for the health care professionals, but also the patients.”

Hamilton noted that in addition to maximizing the value of Trulance, the company will potentially consider pursuing an indication of opioid-induced constipation in the future.

“But right now, we’re focused on building demand not only in CIC, but continuing that momentum with the IBS-C indication,” he said. “We feel very strongly about our label because of the pharmacology — we are the first and only analog of uroguanylin — and also the ease of use — we have one 3-mg once-daily dose approved for both indications. Trulance is the only prescription medication for adults with CIC and now IBS-C that can be taken once-daily, at any time of day with or without food, so patients don’t have to plan their day around their medication.” – by Adam Leitenberger

Disclosures: Hamilton is employed by Synergy, and Chey reports a financial relationship with Synergy.