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FDA Approves Synergy's Plecanatide for IBS-C Indication
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Trulance is the only treatment thought to replicate the pH-sensitive activity of uroguanylin.
The US Food and Drug Administration (FDA) approved plecanatide (Trulance) 3 mg tablet for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults, announced Synergy.
This is the second indication for Trulance, which is already approved for treatment of adults with chronic idiopathic constipation (CIC). It’s is the only prescription medication for adults with CIC and now IBS-C that can be taken once-daily, with or without food, any time of the day. It’s packaged in a unique, 30-day calendar blister pack.
“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,” William Chey, MD, professor of medicine, director of the GI physiology laboratory, co-director of the Michigan Bowel Control Program, University of Michigan said in a statement.
The supplemental new drug application (sNDA), submitted in June, was based on 2 randomized 12-week phase 3 studies evaluating the safety and efficacy of Trulance in adult patients with IBS-C.
More than 2100 patients across the 2 trials received either Trulance 3 mg or 6 mg once daily or placebo. Both trials included a 2-week, pre-treatment baseline period, a 12-week treatment period and a 2-week, post-treatment follow-up period.
Patients in the trials fulfilled the Rome III IBS-C criteria related to abdominal pain and stool changes.
The primary endpoint of the studies was the percentage of patients who were overall responders, demonstrating both ≥30% reduction in worst abdominal pain and an increase of ≥1 complete spontaneous bowel movement in the same week for at least 6 of 12 treatment weeks.
The company only sought approval for the 3-mg dose.
The results deemed statistically superior to placebo in achieving the primary endpoint, in study 1, 30.2% of patients taking 3 mg Trulance achieved significance versus 17.8% of those taking placebo. In study 2, 21.5% of patients taking 3 mg Trulance achieved significance versus 14.2% taking placebo.
In both studies, those who received Trulance experienced a significant reduction in abdominal pain and improvements in stool frequency, stool consistency and straining with bowel movements during the trial period.
In the 2 combined trials, the most common adverse reaction was diarrhea, with an incidence ≥2% and greater than in the placebo group (4.3% versus 1% placebo).
“To-date, real world patient experience has supported the clinical trial data, highlighted by a post-marketing diarrhea rate of less than 0.5% and no reports of severe diarrhea requiring hospitalization since the launch of Trulance CIC indication,” Patrick Griffin, MD, chief medical officer, Synergy, said in a statement. “The IBS-C approval today builds on the already strong CIC label and further establishes Trulance as the first and only uroguanylin analog.”
With the exception of a single amino acid substitution for greater binding affinity, Trulance is structurally identical to uroguanylin which activates GC-C receptors in a pH-sensitive manner, primarily in the small intestine to stimulate fluid secretion and maintain stool consistency necessary for regular bowel function.
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