Effect on Acid Reflux Symptoms Occurring during Sleep of Oral Adhering Melts Containing Only Food Ingredients and Flavor

This chapter describes a study assessing the efficacy of a slowly dissolving adhering oral melt
currently in use for reducing dry mouth during the day and the night in the management of gastroesophageal
reflux (GERD) while sleeping. To provide context, it is worthwhile reviewing the historical
background that led to the idea that this dry-mouth product, XyliMelts, might alter the symptoms of
GERD.
In 2006, Jeff Haley, CEO of OraCoat, Bellevue, Washington, USA, developed a fully dissolving
intraoral adhering melt that could be applied beside an oral ulcer to reduce its pain and duration, now
marketed as Renewing Melts. Subsequently, another formulation incorporating 550 mg of xylitol, 8.5
mg calcium carbonate to neutralize acidity of the adhesive, and a mild mint flavor was studied to see if
it could alter the sensation of dry mouth occurring during sleep; with results indicating that it could
improve perceived dry mouth. XyliMelts was then put on the market and feedback from users
indicated that when used as directed, there seemed to be a reduction in GERD symptoms. Given this,
a randomized controlled and blinded trial was pursued to see whether the reported anecdotes actually
represented a true clinical effect. This study confirmed that it did. Based on this research, one of the
ingredients, calcium carbonate, was increased to 300 mg in a new product to be released under the
brand name AlkaMelts.