• 9/1/2005
  • Sellersville, PA
  • press release
  • biz.yahoo.com

Scandinavian Formulas, Inc., announced today that the U.S. Food & Drug Administration (FDA) has issued over-the-counter (OTC) drug status for its product SalivaSure®, a saliva- stimulating lozenge for relief of dry mouth.

Dry mouth (xerostomia), which can be extremely debilitating, can be caused by many factors including physiologic, radiation therapy (of the head and neck), and the adverse effects of prescription and OTC drugs, such as antihistamines, antidepressants, anxiolytics, diuretics, and decongestants, to name a few. Saliva — a vital part of oral health — provides enzymes to help with the digestion of food and produces a constant flushing of the oral cavity, which keeps the mouth relatively clean and helps to protect it against infection. When the mouth lacks saliva, not only does it produce an unpleasant feeling, but it also causes bacteria to breed, resulting in tooth decay and bad breath. In addition, consuming food and liquids becomes increasingly difficult and the sense of taste is altered.

SalivaSure® works by the unique fruit acid formulation that stimulates the taste buds and activates the production of saliva. A combination of sodium citrate and calcium phosphate acts as a buffer to protect the tooth enamel. In addition, the sweetener xylitol is known to reduce plaque formation and help minimize the development of dental caries, which protect tooth enamel for long-term use. What’s more, SalivaSure® does not interact with prescription medications and is safe for people with diabetes. The lozenge brings instant relief on contact.

“We are extremely excited that SalivaSure will now be available to physicians and dentists for their patients’ use as an OTC product,” said Catherine Peklak, President of Scandinavian Formulas, Inc. “Over 600 medications impair saliva flow, affecting millions of people, particularly elderly individuals who are the most susceptible to taking multiple dry-mouth- causing drugs. We are confident our product will be appreciated by many patients as it is very effective and more convenient than gels, mouthwashes, or even gums that are available as remedies,” Peklak added.