Do We Need a New Treatment for Constipation?

Millions of Americans suffer from a form of constipation called Chronic Idiopathic Constipation (CIC) every year. The American Journal of Managed Care defines CIC as “a functional bowel disorder characterized by difficult, infrequent, and/or incomplete defecation” that is not related to an anatomic or structural abnormality. CIC appears in patients of all ages in all populations with varying symptoms. Multiple forms of treatment exist, ranging from herbal and over the counter options to prescription medications.

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Sometimes it’s hard to talk about bowel movements, even when they are regular and on time. But when they occur too often or not often enough, the topic becomes even more difficult.

Roughly 2 percent of Americans experience persistent constipation each year. It is the most common digestive complaint! Women experience it much more often than men. 

Millions of Americans suffer from a form of constipation called Chronic Idiopathic Constipation (CIC) every year. The American Journal of Managed Care defines CIC as “a functional bowel disorder characterized by difficult, infrequent, and/or incomplete defecation” that is not related to an anatomic or structural abnormality. CIC appears in patients of all ages in all populations with varying symptoms. Multiple forms of treatment exist, ranging from herbal and over the counter options to prescription medications. 

The FDA recently approved Pizensy (lactitol), a new medication from Braintree Laboratories, for the treatment of CIC. So, where does this new medication fit in the treatment of constipation?

Let’s Talk About Constipation First

During the ordinary course of consuming food and drink, the digestive tract withdraws necessary nutrients and expels the remainder as liquid and solid waste. Bowel movements can happen anywhere from just three times a week to three times a day for some people, but even then, there is no “normal” number of times. Each person is different! 

So how infrequent must your bowel movements be to be considered constipation? There is no hard and fast answer. Rather, just like regularity is dependent on the person, so is constipation. Essentially, it is any time you are using the restroom with less regularity. Sometimes it is temporary, due to things like poor diet or inactivity. In some cases, it can be a side effect of medications. Mental health also plays a role, as depression and anxiety can each cause constipation.

If left untreated, constipation can lead to complications like hemorrhoids, anal fissures, or fecal impaction.

How Do You Treat Constipation?

Usually, we begin by trying to identify what is causing constipation and then addressing that issue to stop constipation—if there is no known cause of constipation, then adding more fiber to the diet or increasing activity levels are usually tried first. Increasing water intake also helps. 

If dietary and physical activity is unsuccessful, non-prescription treatments like a fiber laxative such as those that contain psyllium husk may be tried next. The husks come from the seeds of an herb called Plantago ovata. They work by absorbing water and forming a bulkier stool in the digestive tract, encouraging more movement. 

Other over the counter medications like stool softeners, stimulant laxatives, and enemas and suppositories are available as well. While they are generally considered safe for short term use, long term use should be managed by a healthcare provider as these products can interfere with the normal absorption function of the digestive system.  

Prescription medications include agents like Linzess, Trulance, Amitiza, Relistor, and Movantik, each of which has different mechanisms than Pizensy. No generic versions of these drugs are currently available on the marketplace.

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Pizensy 

Braintree Laboratories received approval in February 2020 for the release of their new medication Pizensy for treatment of CIC. The product is a powder that patients mix with a drink and consume once daily to establish regularity in their bowel movements. According to the company’s press release, the drug “is a simple monosaccharide sugar alcohol that exerts an osmotic effect, causing the influx of water into the small intestine leading to a laxative effect.”

One of the advantages of this prescription medication is that patients can control their dosing based on their body’s response. Patients begin by mixing a standard dose of the powder with a beverage of their choice and then can reduce the dose based on how well it is working. 

Pizensy can affect how well other medications are absorbed (similar to other laxatives); therefore, other medications should be taken either two hours before or after Pizensy. Like other agents on the market for CIC, Pizensy is not well absorbed into the bloodstream. As a result, the likelihood of drug interactions with other medications is low. Make sure to always check with your pharmacist or primary healthcare provider first before changing or adding any medications, herbals, or non-prescription medications. 

Pizensy should not be used by anyone with galactosemia (an inability to break down the sugar galactose) or anyone who has an obstruction in their digestive tract.

According to the summary of the clinical trials for Pizensy, the most common side effects were: upper respiratory infections, gassiness, diarrhea, increased blood creatinine phosphokinase (a type of enzyme), belly distention and increased blood pressure. 

So Where Does Pizensy Fit in Treatment of Constipation?

The side effect profile seems pretty benign, and the medication was proven to work in the clinical studies leading up to approval. The deciding factor may be price, but currently no pricing information is available. Additionally, insurance coverage of the medication will determine the cost at the register.

In the same way that regularity of bowel movements is defined by the person, treatment of GI disorders is also highly variable based on the symptoms, the person, and the causes. Pizensy’s place in that realm of treatment remains to be seen. It is well tolerated and effective, so price may be the biggest factor.

References:

BioSpace. Sebela Pharmaceuticals Announces FDA Approval of Pizensy™ for oral solution for the Treatment of Chronic Idiopathic Constipation in Adults. BioSpace. https://www.biospace.com/article/sebela-pharmaceuticals-announces-fda-approval-of-pizensy-for-oral-solution-for-the-treatment-of-chronic-idiopathic-constipation-in-adults/. Published March 2, 2020. Accessed July 24, 2020.

Center for Drug Evaluation and Research. Drug Trial Snapshot: PIZENSY. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-pizensy. Accessed July 24, 2020.

Constipation; Symptoms, Causes, Treatment & Prevention. Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/4059-constipation. Accessed July 24, 2020.

DailyMed – PIZENSY- lactitol powder, for solution. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=579ef0af-4aaf-49b2-a5e4-fa6ea1e22cb6. Accessed July 24, 2020.

Over-the-counter laxatives for constipation: Use with caution. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/constipation/in-depth/laxatives/art-20045906. Published June 6, 2017. Accessed July 24, 2020.

Psyllium. Mount Sinai Health System. https://www.mountsinai.org/health-library/supplement/psyllium. Accessed July 24, 2020.

TR; SAK. Epidemiology of constipation in the United States. Diseases of the colon and rectum. https://pubmed.ncbi.nlm.nih.gov/2910654/. Accessed July 24, 2020.

Update on the Management of Chronic Idiopathic Constipation. AJMC. https://www.ajmc.com/journals/supplement/2019/reviewing-treatment-data-and-the-role-of-serotonin-in-cic/update-on-the-management-of-chronic-idiopathic-constipati. Accessed July 24, 2020.

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