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May 4, 2020

New Study Shows Promising Compounded Drug-Delivery Option for Patients with Oral Inflammatory Condition

MucoLox™ adheres to mucous membranes as it delivers active ingredients, increasing contact time between medication and the affected tissue.

HOUSTON – May 4, 2020 – Researchers have completed a pilot study that shows promise for patients with oral lichen planus (OLP), a condition that can result in a burning sensation, pain and ulcers in the mouth. Results of the study, which were recently published by the dental journal Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, show that a compounded steroid solution that included a patent-pending drug-delivery technology called MucoLox™ was clinically well tolerated and more effective for patients with this condition than a commonly used solution of the same steroid.

OLP is a chronic inflammatory condition caused by the body’s immune system attacking tissues in the mouth. According to researchers, this condition occurs in 1% to 2% of adults.

The study tested the tolerability and effectiveness of a compounded oral steroid solution compared with a standard solution in a group of 20 adults who had been diagnosed with OLP. The subjects swished the solutions in their mouths for five minutes, then spit them out, doing this three times per day for four weeks. Twelve of the adults used a commonly prescribed liquid with dexamethasone, a corticosteroid that can help reduce inflammation. The other eight adults used a liquid with dexamethasone and MucoLox™, a gel that adheres to mucous membranes (mucoadhesion) and that is used to make customized medications for patients with certain oral conditions.

The study authors are: Alessandro Villa, DDS, PhD, MPH; Vidya Sankar, DMD, MHS; Lisa Bennett Johnson, RDH, MS, MPH; and Herve Sroussi, DDS, PhD, with Brigham and Women’s Hospital and the Harvard School of Dental Medicine in Boston, Massachusetts, and Gus Bassani, PharmD, with PCCA, an FDA-registered and -inspected chemical repackager and relabeler in Houston, Texas, which manufactures MucoLox™. They hypothesized that the solution with MucoLox™ would be well tolerated and lead to better outcomes because it would adhere to oral tissue and increase the contact time between the medication and the tissue. The study resulted in better objective and subjective outcomes with the mucoadhesive drug-delivery system MucoLox™. To learn more about MucoLox™, click here.

“One of the factors determining how well a medication works is whether it can get to a desired site of action in the body and exert a beneficial effect,” said Bassani, who serves as Chief Scientific Officer at PCCA. “If we can improve medication delivery to that site and prolong its effects, we may be able to improve outcomes. It is exciting to see the improved clinical response in this preliminary study, resulting from the use of the MucoLox delivery system.”

The authors acknowledged some limitations to their research, including the use of a small cohort of patients, and wrote that larger studies are needed to confirm their findings. However, this study provides preliminary data on a promising drug-delivery option for patients with OLP.

ABOUT PCCA

PCCA helps pharmacists and prescribers create personalized medicine that makes a difference in patients’ lives. As a complete resource for independent compounding pharmacists, PCCA provides high-quality products, education and support to more than 3,500 pharmacy members throughout the United States, Canada, Australia and other countries around the world. Incorporated in 1981 by a network of pharmacists, PCCA has supported pharmacy compounding for more than 39 years. Learn more at www.pccarx.com.

MEDIA CONTACT

Kim Speairs, APR, MBA, Director of Communications and Engagement, PCCA, 281.709.8277, kspeairs@pccarx.com