Ardelyx Uses DTC Crackdown Lessons to Shape Ibsrela TV Ad

Ardelyx says it incorporated lessons from FDA's recent prescription drug advertising enforcement actions into its first television advertising campaign for Ibsrela (tenapanor), a treatment for irritable bowel syndrome with constipation (IBS-C). Specifically, the company says its new television commercial used static safety disclosures and simplified visuals to address the agency's concerns about distracting imagery and inadequate risk presentation.

The company developed its “Because Ibsrela Can” campaign after reviewing untitled letters issued by FDA's Office of Prescription Drug Promotion (OPDP) over the past 12 to 18 months, according to a 9/21 report in Medical Marketing + Media.

Jami Giordano, Ardelyx's senior vice president and general manager, told MM+M that the company's regulatory team monitored FDA enforcement letters and shared recurring concerns with its marketing, promotional review, advertising agency and production teams during development of the campaign. The company paid particular attention to FDA's objections to advertising that uses rapidly changing imagery, moving text or other visual elements that may distract consumers from important risk information. In the Ibsrela commercial, certain safety information, including contraindications and potential adverse reactions, is displayed clearly on screen rather than competing with rapidly changing visuals, according to the company.

The approach follows increased FDA scrutiny of direct-to-consumer pharmaceutical advertising, including enforcement letters challenging promotional materials for overstating efficacy, minimizing risks or presenting misleading impressions of a drug's approved uses and benefits. The campaign represents Ardelyx's first major television advertising effort for Ibsrela after more than four years of marketing the drug primarily through healthcare professional education.

The company is targeting patients who remain dissatisfied with their current IBS-C treatment and may be unaware of other available options. Ardelyx is supplementing the television campaign with digital advertising, patient education materials, paid search, audio advertising and other promotional activities.