Global Health Solutions to Rapidly Advance Topical Impetigo Drug Candidate Following Successful FDA Meeting
LOS ANGELES, May 10, 2018 /PRNewswire/ -- Following a successful program development meeting with Food and Drug Administration's Anti-Infective Division, Global Health Solutions shall pursue rapid development of its topical impetigo drug candidate for new drug submission. Impetigo is a highly contagious, superficial skin infection that most commonly affects children two to five years of age. Among children, impetigo is the most common bacterial skin infection and the third most common skin disease, overall. Since 2000, the estimated population with impetigo at any one time is more than 162 million children, with no signs of statistical improvement in the number affected over decades of analysis.
Impetigo treatment is intended to relieve discomfort, reduce scarring, as well as prevent unwanted spread of the highly-contagious, offending organisms. Current standards of care remain antiquated, topical antibiotics, which are increasingly showing resistance to the organisms that lead to impetigo. Children affected by the disease are removed from school to prevent unwanted contagion, resulting in economic loss to the school system, as well as work income for caretakers. Impetigo patients will benefit from a gentle, non-antibiotic treatment option that not only soothes symptoms, but eliminates the organisms that lead to impetigo. The Global Health Solutions asset is bolstered by powerful in-vitro and in-vivo data that support its expectation of accomplishing both goals in clinical trials.
Global Health Solutions Founder and CEO, Bradley Burnam, states: "We are encouraged by the positive interaction with FDA. This is a high-need indication with little to no innovation. We expect our non-antibiotic, topical impetigo candidate to be adopted as standard of care upon completion of our regulatory goals, as there is no more important population than children for addressing the long-term, deleterious effects of antibiotic resistance." Global Health Solutions Chief Medical Officer, Dr. Neil Ghodadra, states: "Given the global concern regarding increased antibiotic resistance, there is an urgent need in this highly-susceptible patient population for a non-antibiotic, biocidal treatment option. Our drug candidate has proven itself capable of eliminating organisms that are known to cause impetigo on contact and over time, while showing no irritation or sensitization during in-vivo testing."
Global Health Solutions is a 'concept-to-approval' research and development organization that employs its proprietary Permafusion™ technology to address pervasive dermatologic and chronic wound conditions. PermaFusion™ creates a permanent, stable fusion of liquid in petrolatum that maximizes bioavailability of active ingredients while minimizing insult to tissue. The Global Health Solutions impetigo candidate leverages the proven PermaFusion™ platform to address this high-need, global epidemic currently lacking in treatment options.
Global Health Solutions, LLC
Forward Looking Statements Disclaimer: The statements contained herein may include prospects, statements of future expectations, and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance, or events may differ materially from those expressed or implied in such forward-looking statements.
View original content with multimedia: http://www.prnewswire.com/news-releases/global-health-solutions-to-rapidly-advance-topical-impetigo-drug-candidate-following-successful-fda-meeting-300646751.html
SOURCE Global Health Solutions