New REMESENSE TOOTH DESENSITIZER for treating tooth hypersensitivity

Nuline Pharmaceuticals, LLC announces the introduction of REMESENSE™ (dipotassium oxalate 3%) TOOTH DESENSITIZER, an Rx Class II medical device now available in the U.S. REMESENSE™ was introduced globally in 2008. It is presently sold in 16 countries, ranging from England and the European Union to Asia and Africa. Nuline expects to launch REMESENSE™ in Canada and other countries later this year or by early 2011.

Tooth hypersensitivity is an exaggerated response to sensory stimuli that usually cause no response in a normal healthy tooth. Except for sensitivity associated with tooth bleaching or other tooth pathology, the primary underlying clinical cause of tooth hypersensitivity is dentin tubules exposed to the oral environment.

It is estimated that dentinal hypersensitivity affects 57% of the world's population. The prevalence of dentinal hypersensitivity has been reported to occur in more than 40 million people in the U.S., encompassing over 14% of all dental patients or up to 30% of adults at some point during their lifetime. Women may be affected more often than men. Up to 75% of patients who have had their teeth professionally whitened have dentinal hypersensitivity. Length of exposure, concentration, and pH of the bleaching agent will factor into the degree of hypersensitivity.

REMESENSE™ presents the dental profession with a unique system to treat tooth hypersensitivity. Treatment can be initiated in the dental office, a prescription given to the patient, and treatment then can be continued at home.

REMESENSE™ provides a tray and impregnated foam strips that offer:

• A pressure gradient that is higher compared to a conventional solution or gel application

• An active ingredient proven to reduce hypersensitivity that is embedded in a foam matrix and is released in a sustained and controlled manner

REMESENSE™(dipotassium oxalate 3%) offers the patient the following features and benefits:

• Immediate relief following a 10-minute application

• Unique, easy to use tray and impregnated foam strips

• Affords up to a month's protection

• Non-abrasive application

• Available for in-office and at-home (Rx) use

REMESENSE™ contains dipotassium oxalate, which reacts with calcium ions in the mouth to form calcium oxalate crystals. These crystals occlude exposed dentin tubules, alleviating hypersensitivity. Potassium ions have also been shown to modify nerve excitability, thus reducing the pain response.(6)

Competing products already in the marketplace include OTC desensitizing toothpastes that take 3 to 4 weeks of use before offering varied results and require continual daily use. Products used in the dental office include burnishing pastes and products requiring air drying, problems for the patient whose teeth are already sensitive.

REMESENSE™ is available in a professional size for distribution directly to the dental office and an Rx 3-month supply for distribution through pharmacies.