SALINUM

The liquid is a linseed extract that contains gel-forming substances (poly-saccharides) that have been shown to have good lubricating qualities.

SALINUM^TM is a saliva substitute, indicated for the relief of symptoms of dry mouth, or xerostomia. The liquid is a linseed extract that contains gel-forming substances (poly-saccharides) that have been shown to have good lubricating qualities. Salinum can offer symptom relief for about one hour, in comparison to its competitors, which provide relief for about half an hour. The product is preserved and buffered and does not contain sugar.

Salinum is presented in a liquid format, in PET bottles of 300ml, 80ml or 30ml (Sample size). The bottles have a single label, a leaflet and an outer carton.

A dose of Salinum is approximately 2ml and this may be poured into a teaspoon or into a measuring cup, depending on the presentation of the product. It may be used as frequently as required, since there is no upper limit for usage. Average usage is approximately five doses per day. The product is preserved and buffered, and is safe if ingested.

Disease overview

Xerostomia, or 'dry mouth' is the abnormal reduction of saliva, usually due to medication, disease, surgery or ionising radiation. It is characterised by feelings of a dry mouth, but the relationship between the symptoms (feelings of dry mouth) and the signs (actual lack of saliva) may vary. Xerostomia is extremely common in the general population and even more common in specific groups of patients (with cancer, diabetes, rheumatoid conditions, and those receiving radiotherapy to the head and neck, various medications, including CNS medications, e.g. psychiatry).

Product benefits & advantages

Current methods of symptom relief available for xerostomia have a series of problems. Many do not provide any symptom relief for patients with more severe xerostomia. When patients do use saliva substitutes (usually more severely affected patients), they report that they have a short duration of action. Most products are also flavoured, which is less favoured by patients wishing to use them regularly.

SALINUM^TM offers an improved duration of action over other saliva substitutes and data shows that patients prefer it to carboxymethylcellulose, one of the most commonly used products. Patients have also reported that the neutral taste is preferred for a product that is being used so frequently.

Other saliva substitutes are available, however none are promoted on a large-scale. Because of this and the dissatisfaction with the duration of action of other saliva substitutes, the market is open to a new and well-targeted saliva substitute.

SALINUM^TM offers the following benefits:

a) To clinicians and patients

• an improved duration of action over other saliva substitutes

• not a drug - so it does not add to the patients' pharmacological load

• data shows that patients prefer it to carboxymethylcellulose, one of the most commonly used products

• a neutral flavour - ideal for patients using it long-term

• excellent safety profile (unlike pilocarpine and cevimeline hydrochloride, systemic saliva stimulants)

• saliva substitution for patients who are unable to produce their own saliva

• simple dispensing due to medical device classification

• No known drug interactions

Stage of development

In the European Union, under the provisions of EEC Directive 93/42/EC Salinum is classified as a Class I Medical Device. The Medical Device Directive applies to all European Union countries and this means that Salinum can be sold freely within these countries, without further registration requirements. The CE mark signifies the product's conformity with the Directive.
Furthermore, in the United Kingdom, Salinum has been granted reimbursement status.

In the United States of America, application has been made to classify Salinum as a prescription and OTC 510(k) Medical Device (Rx).

 

Registered

A US patent was granted for Salinum on 9th November 1993 and is due to expire in 2013. The claims are that Salinum is a composition for use as a saliva substitute, and in combination with antifungals or antivirals.

A European patent was granted on 20th July 1994 for Austria, Belgium, Switzerland, Germany, Denmark, Spain, France, Great Britain, Greece, Italy, Holland, Sweden, Portugal, Lichtenstein, Luxembourg and Monaco.

Salinum is a registered trade mark in the European Union, Norway, Switzerland, Canada and the USA.

Marketing companies are required to sell Salinum^TM in key territories around the world.