The following written comments were submitted by IFFGD president, Ceciel T. Rooker, to the US Food and Drug Administration (FDA) in connection with a October 17, 2018 joint meeting of the FDA Gastrointestinal Drugs Advisory Committee to discuss approval of prucalopride:

The International Foundation for Gastrointestinal Disorders (IFFGD) commends the FDA on its commitment to ensuring the safety and effectiveness of treatments for conditions that impact the American public.

Established in 1991, IFFGD is a patient-driven nonprofit organization dedicated to assisting individuals affected by chronic gastrointestinal (GI) illnesses by providing education and support for patients, the family members, healthcare providers, and the public. IFFGD also works to advance critical research aimed at broadening our understanding of the basic mechanisms and clinical care of these conditions and providing patients with better treatment options, and perhaps one day, cures. IFFGD has worked closely with the FDA to facilitate greater involvement of the patient voice in health policy and regulatory decisions, including taking an active role in the 2015 FDA Patient-Focused Drug Development public meeting on Functional GI Disorders.

Today, I am writing to you regarding Docket No. FDA-2018-N-0055 for “Gastrointestinal Drugs Advisory Meeting; Notice of Meeting; Establishment of a Public Docket; Request for Comments” to discuss new drug application (NDA) 210166 for prucalopride tablets for oral administration for the treatment of chronic idiopathic constipation (CIC) in adults.

We applaud the FDA’s continued interest in investigating therapies on behalf of the estimated 35 million Americans living with CIC. CIC is one of the most common GI illnesses seen by gastroenterologists and has been reported to account for up to one-half of patient care time (Chang JY, et al. 2010. While all ages are affected, it is especially prevalent and burdensome with increasing age. Other risk factors for the development of CIC include female gender, non-white race, and lower socioeconomic status. Traditional definitions of the condition are based on stool frequency, but more recent guidelines set forth by the Rome IV diagnostic criteria include patient-reported symptoms such as straining, the feeling of incomplete evacuation, evacuation of small or hard stool, excessive time spent trying to have a bowel movement, or the need to manually facilitate stool passage. Other abdominal symptoms, such as bloating, distension, and discomfort may also be associated with the condition.

Symptoms of CIC can greatly diminish the productivity and quality of life of those affected, preventing them from engaging in personal and professional activities. As a “functional disorder,” CIC affects the way the muscles and nerves work, but the bowel does not appear to be damaged on medical tests. Without a definitive diagnostic test, many cases of CIC go undiagnosed or misdiagnosed for years. Stigma associated with bowel symptoms often acts as a barrier to treatment, and the trivialization of the symptom of constipation may contribute to prolonging the time between symptom onset and a proper diagnosis and appropriate care. This may lead many patients to self-medicate, reluctant to discuss embarrassing symptoms even with their doctor. And, even after CIC is identified, treatment options are limited, and treatment effectiveness varies widely from patient to patient.

While two prescription pharmacotherapies (linaclotide and lubiprostone) have recently been made available for the treatment of CIC, broadening treatment options for patients, many patients remain dissatisfied with available treatments. One of the largest studies of this patient population, the BURDEN CIC study reported in Advances in Therapy (Harris LA, et al. 2017., revealed that both patients with CIC and healthcare providers continue to be dissatisfied with current management pathways. Among those surveyed, only 40% were satisfied with OTC laxatives and only 56% were satisfied with current prescription therapies, citing inadequate efficacy and side effects (mostly diarrhea) as primary causes for dissatisfaction.

Because of the heterogenous nature of the disorder, no one treatment pathway will effectively address the needs of all patients. Long-term solutions will require a combination of education and awareness initiatives to break down barriers to treatment and the availability of safe and effective treatment options. This will take the contribution of drug developers and manufacturers, regulatory agencies, physicians and other healthcare providers, and patients and patient-driven nonprofit organizations like IFFGD. The pharmaceutical industry needs to provide the data necessary for accurate analysis of the risks and benefits of the medication they develop, and they need to work closely with physicians, pharmacists, and patients to ensure clear and useful prescribing information. Physicians need to be well-informed about the experiences and perspectives of their patients with CIC and work alongside their patients to help them achieve their health goals. Regulatory agencies, like the FDA, have an obligation to ensure that safe and effective medications are made available. And, finally, patients and patient organizations need to make their needs heard and raise awareness to educate the public about the prevalence and burden of symptoms.

We urge the FDA to consider the impact CIC has on patients when looking at the risks and benefits of any medication approved to treat the condition. If prucalopride is shown to be safe and effective for adults with CIC, it will represent the potential for symptom relief for many of those affected.

We thank you for the consideration of our comments and welcome the opportunity to work in conjunction with the FDA to obtain input from patients on the drug development process.

Nancy J. Norton, IFFGD Founder
Ceciel T. Rooker, IFFGD President
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Our mission is to inform, assist and support people affected by gastrointestinal (GI) disorders.

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