Two Aussie pharmacists from Melbourne have invented a TGA approved solution to a debilitating condition that affects one in five Australians – painful mouth ulcers can now be treated for the first time ever with a band-aid like patch that reacts with saliva in the mouth and protects the ulcer while it heals. The news comes as welcome relief for sufferers looking for an effective treatment after the TGA pulled popular mouth ulcer gel Bonjela from supermarket shelves last year due to toxicity concerns.
Pharmacists Abdul Azzam and Nael Karim’s invention was fast-tracked when the sister of their business partner, Omar Sukkar, succumbed to an autoimmune condition that gave her debilitating mouth ulcers. Omar pressed them to find a solution to alleviate her suffering. Together the trio created a patch that can withstand moist environments for 24 hours after recognizing the lack of effective long-term treatment options available. The patch will also provide relief for cancer patients and other immunocompromised individuals who are especially prone to debilitating mouth ulcers. To obtain TGA approval, the innovative patch had to demonstrate its effectiveness in promoting the speedy recovery of mouth ulcers.
“As pharmacists, Abdul and Nael are at the coalface dealing with customers daily who are searching for an effective way to deal with painful mouth ulcers,” said Omar Sukkar. “Mouth ulcers are incredibly common, affecting around 20% of the population at any given time, yet treatments have been limited. Our Australian-first patch provides prolonged soothing relief, acting as a protective barrier to avoid further aggravating the ulcer. Other treatments are in the form of gels or creams that work by numbing the pain only. These solutions are problematic – they only stay on the affected area for less than five seconds because saliva washes them away. Saliva is one of the key issues as it doesn’t allow the mouth ulcer to heal and causes pain when in contact with the inflamed skin. The genius of UlcerEze is it comes in a patch form that is activated by that very same saliva, forming a barrier that prevents the exposure to saliva and air which makes mouth ulcers so painful.”
The new patch treatment provides a much-needed solution after Bonjela Teething and Mouth Ulcer Gel was pulled from supermarket shelves last October. Dr Mostafa Khalafalla, a GP from Melbourne, explains why. “The Therapeutic Goods Association (TGA)Â reclassified it from a Schedule 1 to a Schedule 2 medication, meaning it can now only be purchased at pharmacies. This decision was driven by concerns about the excessive and incorrect use of its active ingredient, choline salicylate, especially in children. The TGA do not recommend teething gels, regardless of choline salicylate content, due to a lack of evidence of efficacy and potential harm.”
While the TGA does not recommend gels like Bonjela, the governing body has approved claims that UlcerEze’s patches not only help with pain relief but also speed up healing following two thorough clinical trials. The first trial evaluated its effectiveness in relieving pain, and the second was to prove UlcerEze patches truly promoted healing, measuring changes in the physical size of the mouth ulcer after a number of days. The trials successfully proved the effectiveness of the patches, warranting the TGA’s claims and offering Australians a new and improved alternative treatment option.
UlcerEze uses three active ingredients that are all naturally derived: silicon, which is one of the best healers for wounds, and calcium and phosphorus, which act as anti-inflammatories and help the mucous membrane heal faster. The patch form allows the natural active ingredients to be in contact with the affected area for a prolonged period of time, making it work much quicker than any other products on the market.
The inspiration for UlcerEze came from Omar’s determination to help his younger sister, who suffered from recurrent, debilitating mouth ulcers due to an autoimmune condition. “This issue really hit home when it affected my sister. I was mentioning this to Abdul and Nael and asking for alternative treatments when they told how dyer the problem was in Australia. She was in so much pain. With their knowledge, and my determination to help my sister, we unpacked what needed to be done to attack why mouth ulcers were not healing quickly. Through trial and error, we created the UlcerEze patch, which proved effective in clinical trials. Its all-natural formula meant it didn’t interact with medications, while the patch format ensured ease of use, pain reduction, and improved healing.”
This alternative looks set to assist the millions of people suffering from this painful condition around the world, particularly immunocompromised individuals, like Omar’s sister, who are especially prone to recurring mouth ulcers. Plans are also underway for initial trials with major oncology departments in Australia to help provide relief for cancer patients.
