P D McGrath Receives 510(k) Clearance To Market Sucralfate HCl Topical Paste(TM)
CHICAGO, Feb. 21 /PRNewswire/ -- Patrick D. McGrath Ph.D., a pharmacologist working independently of industrial or academic sponsorship, has received 510(k) clearance to market Sucralfate HCl Topical Paste(TM) for the management of oral lesions such as aphthous ulcers and stomatitis associated with cancer therapy.
Under US Patent Number 6,391,860, a paste of sucralfate is formed by reaction with controlled amounts of HCl prior to application to wounds. The ratios of sucralfate and HCl are controlled to trigger sucralfate polymerization while avoiding complete sucralfate dissolution. Because this paste needs no other ointment forming substance it is applied directly to wounds at a concentration close to 100% as the acid-activated sucralfate polymer.
Application to aphthous ulcers requires no special drying of the wound base. Unlike caustic treatment, application of sucralfate paste to aphthous ulcers or other oral lesions is pain free. Aphthous ulcer symptom relief is prompt and treatment beyond 24 hours is rarely required. Sucralfate HCl Topical Paste(TM) is indicated for use in the management of mouth lesions of all types including aphthous ulcer, stomatitis, mucositis, minor lesions, chafing and traumatic ulcers, abrasions caused by braces and ill fitting dentures, and lesions associated with oral surgery.
"Reaction of sucralfate with HCl prior to application to wounds provides a practical approach to expanding the wound covering benefits of sucralfate to indications other than peptic ulcer disease," said Dr. McGrath. "Literature over the last 10 years tells me that the primary research and therapeutic interest in sucralfate lies primarily in indications other than peptic ulcer disease. With patent exclusivity until September 2019, continued development of Sucralfate HCl Topical Paste(TM) in other wound types is commercially practical."
Sucralfate HCl Topical Paste(TM) is compounded at the time of use by a pharmacist or prescriber. Because sucralfate polymerization is triggered prior to dosing, the FDA ruled in favor of Dr. McGrath's formal request for designation, finding that Sucralfate HCl Topical Paste(TM) is appropriately regulated as a medical device. All other sucralfate dosage forms remain regulated as drugs in the US.
Inquiries from potential development and marketing partners may be directed to Dr. McGrath at KatenPaste@comcast.net .Patrick D. McGrath Ph.D.
CONTACT: Patrick D. McGrath Ph.D., +1-847-543-4138, KatenPaste@comcast.net