Dyve Bioscience, a biotech drug delivery company developing novel transdermal technologies for delivery of molecules through the skin, announced positive results from a human proof-of-concept pilot study of transdermal sodium bicarbonate for reducing pain associated with an acute gout flare.
An abstract of the results of the gout study was selected for oral presentation last week at the prestigious European Crystal Network 10th workshop 2019 in Paris, and was presented by Lisa Misell, Ph.D., VP of Clinical and Medical Affairs for Dyve Bioscience. Findings of the randomized double-blinded placebo-controlled pilot study demonstrated the effectiveness of topical transdermal-delivery sodium bicarbonate for treating the pain associated with an acute gout flare.
“Our mission is to change the standard of care for people suffering from acute gout pain, by providing immediate relief through a safe transdermal technology,” said Dr. Misell. “We are pleased with the results of this study and the company is preparing to advance the treatment into the next phase of development.”
Principal investigators Smitha Reddy, M.D., Arthritis Care and Research Center, and Arthur Ray Mabaquiao, M.D., Cabrillo Center for Rheumatic Diseases, both in San Diego, evaluated outcomes of pain relief, days until resolution and improvement in range of motion. The study enrolled 24 men and women, aged 18 to 65, with history of gout. The active treatment patients received lotion containing sodium bicarbonate and menthol while the placebo group received lotion without those ingredients. Participants were told to report to clinic within 36 hours of flare onset; all were taking 0.6mg/d or were started on 0.6mg/d colchicine.
Patients in the study were directed to apply 10 mL of lotion every 4 hours, three applications a day, to the entire limb of the target joint (identified by investigator using questionnaire) and up to two other involved joints. Follow-up time points were 15 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, and 14 days, with the data collected by phone.
“We are thrilled that a high percentage of patients had immediate pain relief, as early as 15 minutes after applying treatment,” said Dr. Reddy, Member of Dyve Bioscience’s Scientific Advisory Board and principal investigator. “This could prove to be a major advancement for those suffering from gout, given the current treatment options available, which can take days to provide relief.”
Gout afflicts approximately 2-4% of the US population (10M+) and can range as high as 10% in some countries.1 However, the vast majority of treatments focus on chronic management, with very few that work within the first days following an acute attack. Of those options, some are associated with risks that make them unavailable to some patients.
1. Kuo CF, Grainge MJ, Zhang W, Doherty M. Global epidemiology of gout: prevalence, incidence and risk factors. Nat Rev Rheumatol. 2015 Nov;11(11):649-62.