This news release issued by the U.S. Food and Drug Administration announces the agency’s approval of the drug plecanatide (marketed as Trulance) to treat adults with chronic idiopathic constipation (CIC), a form of constipation for which there is no consistent medical explanation.
The release notes that there are other treatments for the disorder and that this approval expands the options available. It also nicely clarifies that the drug has not been proven safe for those under age 18 and that it can cause mild to serious diarrhea. But it left out other side effects observed in the studies and is vague about the benefits. It would have been nice to include some numbers to put the potential value of the drug in perspective. It does explain that volunteers in two clinical trials “were more likely to experience improvement” in the frequency of bowel movements than those getting placebo, and “had improvements” in consistency and straining. But some quantitative or qualitative information would have been helpful.
In both clinical trials, the overall positive response rates were about 20 percent compared to 10 to 13 percent for placebo which suggests only a modest benefit — and the release could have pointed that out.
As the release points out, constipation afflicts an estimated 42 million Americans, according to the National Institutes of Health, and the costs of treating, managing and coping with chronic forms and other “bathroom diseases” is staggering, both in dollars, doctor visits, and human suffering. Most of the historic means of treating or preventing CIC require eternal vigilance, and have serious limitations. The irritable bowel syndrome and constipation “industry” is lucrative, composed of products and advice that carry side effects of their own, and with which many people cannot comply over long periods of time. As a result, new drugs designed to target specific biochemical pathways linked to CIC can become instant (and expensive) best-sellers for legions of desperate patients, and news releases and stories need to be especially cautious about the limitations of these drugs and how they compare to traditional and less expensive alternatives.
Since the FDA evaluates drugs without consideration of cost we’re rating this Not Applicable. But we look forward to the day when FDA news releases include some mention of cost in its message. The value of a new drug is a function not just of how well it works, but its cost-effectiveness.
Pricing information for Trulance is likely to come soon in the wake of the FDA’s approval. For reference, other drugs aimed at the inflammatory bowel/gastrointestinal disorder market have carried high price tags. One such drug costs about $380 for a month’s supply of 30 capsules.
As noted in the summary above, the release did not provide readers with a realistic picture of the actual rate of improvement over placebo in the two clinical trials cited by the FDA in its approval process.
We rate this Satisfactory because the release includes the restrictions on pediatric use and the risk of severe diarrhea. The release would have been even better if it had mentioned how often the volunteers experienced side effects and the full scope of side effects.
The release describes the protocol of the studies used as a basis for its approval (“safety and efficacy of Trulance were established in two 12-week, placebo-controlled trials including 1,775 adult participants. Participants were randomly assigned to receive a placebo or Trulance, once daily.”)
We wish the release had included where the studies were published so that journalists and other interested readers can easily find more information. Most health intervention news releases do include these references.
No mongering here; CIC is widespread. The release provides context on the condition by citing its prevalence.
Although the release notes that Synergy Pharmaceuticals Inc. makes the new drug, it does not say where the clinical trial results were published or what groups supported or carried out the research.
A mention that there are numerous other prescription medications, over-the-counter drugs and lifestyle treatments available for this condition would have been beneficial here.
The FDA release announces approval and most readers will understand that this is essentially the last big step in market availability. The release would have been stronger had it noted that the drug may not be available widely for a short time.
The release could have noted in a bit more detail how this drug works compared to other drugs used to treat CIC, and especially how it differs from over-the-counter and “home” remedies.
The release doesn’t contain any unjustifiable language.