Dry mouth can be extremely unpleasant to endure and it leads to a range of health complications. Pilocarpine is a medicine that improves saliva production, and it is available in many countries to treat dry mouth but not Australia. We are testing a pilocarpine tablet formula that your doctor will be able to prescribe to be made up by compounding pharmacies.


Clinical trial – pilocarpine orally dissolving tablets vs placebo

  • We conducted that compared pilocarpine orally dissolving tablets with placebo
  • It was an 18-day trial designed to test whether people with dry mouth benefit from using the pilocarpine orally dissolving tablets three times a day
  • We recruited people living in their own homes and not receiving active treatment for cancer
  • 8 people took part, with a variety of causes of their dry mouth
  • This trial has been stopped early due to slow recruitment.
  • The trial will be re-visited in the future in a subsequent project, with recruitment via hospitals.

Please contact Associate Professor Kathryn Steadman for further information.


XEROSTOMIA or dry mouth is a major problem that many people experience, especially those who have received radiotherapy for the treatment of head and neck cancer. It also accompanies other diseases such as Sjögren syndrome. Over 100 medications can cause dry mouth such as antidepressants, opiates, antihypertensives, bronchodilators, proton pump inhibitors, antipsychotics, antihistamines and diuretics.

SALIVA plays many vital roles in our daily life and people with reduced saliva production can experience a variety of health problems.

REDUCED SALIVA can lead to many health problems such as altered taste perception, increased susceptibility to oral infections, formation of dental caries, oral mucositis (diffuse ulcerative lesions of the movable mucosa of the mouth and oropharynx, with consequent pain of such severity that require opioid-level analgesics), burning sensation in the mouth, poor denture fit, oral discomfort, sore throat, vocal dysfunction, difficulty swallowing foods and/or liquids. All of these collectively lead to poor nutritional status of the patient and weight loss due to significant loss of appetite.

PILOCARPINE is a prescription medication that stimulates the nerves supplying the salivary glands. This stimulates the production of your own saliva. The effect lasts for about three hours, and so it is usually taken as a dose of 5 mg three times daily, before food so that saliva produced helps patients to chew and swallow their meal.

IN AUSTRALIA pilocarpine is only available as eye drops. When these eye drops are prescribed to be taken by mouth for treatment of dry mouth they taste bitter and hinder patient compliance with treatment. Pilocarpine conventional tablets are available for treating dry mouth in many countries around the world, for example USA, UK and Europe.

OUR RESEARCH investigates a new pharmaceutical preparation of pilocarpine, Orally Dissolving Tablets (ODTs), which are little tablets that dissolve rapidly in the mouth. ODTs can be prepared in compounding pharmacies. The ODTs will be flavoured to disguise the disagreeable taste of pilocarpine. This research will provide information about whether pilocarpine ODTs are effective in treating dry mouth, and this information will help to improve management of dry mouth in Australia.


PROJECT MEMBERS

Associate Professor Kathryn Steadman

Mrs Rose Estafanos

Professor Geoff Mitchell

Dr Esther Lau

Dr Hugh Senior

Dr Jane Nikles

Associate Professor James McGree

 

Project members

Associate Professor Kathryn Steadman

Director of Teaching and Learning
Associate Professor
School of Pharmacy