Plain Language Summary of Publication: Does crushing vibegron 75 mg tablet affect its safety or the amount of vibegron in the body over time in healthy adults?

Abstract

What is this summary about? This is a plain language summary of an article published in the journal Clinical Pharmacology in Drug Development. It is about a study of a medicine called vibegron. Vibegron is approved by the US Food and Drug Administration (also called the FDA) to treat overactive bladder, also known as OAB. It may be easier for people with swallowing issues to take a pill by crushing it and mixing it with applesauce instead of swallowing it whole. Researchers did this study to find out if vibegron could be safely crushed and mixed with applesauce. Participants took vibegron that was either crushed or intact, and researchers compared how much vibegron made it into the bloodstream over time. The researchers asked whether people who took crushed vibegron had more unwanted medical events (called adverse events) than people who took vibegron as an intact pill. What were the results? Crushed vibegron tablets did not change in applesauce for 4 h at room temperature. Just over half of the participants (53%) said that the taste was not different than expected. The amount of vibegron in blood over time was similar between those who took crushed vibegron and those who took intact vibegron. The most common adverse events were headache, constipation, and nausea. No participant experienced a serious adverse event during the study, meaning that no adverse events required hospital care or caused permanent damage or disability. Adverse events that might be related to vibegron occurred in seven participants (23%) after they took crushed vibegron and six participants (20%) after they took the intact pill. What do the results mean? The results of this study show that vibegron can be crushed and taken with applesauce without increases in adverse events compared to taking the intact pill. Crushed vibegron did not change in applesauce and the amount of vibegron in blood over time was similar when vibegron was crushed in applesauce or taken whole. This means that people may take vibegron as a crushed or intact pill for overactive bladder. This may be particularly important for people with difficulty swallowing. Who should read this article? This article is for people with overactive bladder symptoms who have a hard time swallowing pills. It may also be helpful for their families and care partners, and for health care professionals who care for people with overactive bladder. Where can I find the original article on which this summary is based? The original article is called "Pharmacokinetics and Safety of Vibegron 75 mg Administered as an Intact or Crushed Tablet in Healthy Adults." You can read the original article published in Clinical Pharmacology in Drug Development at this link: • https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.1169.