Salofalk® (mesalazine) oral granules and enemas
approved for marketing in Australia.

May 16th 2002

Ulcerative Colitis is the most common chronic Inflammatory Bowel Disease (IBD) with an incidence of about 5 new cases per 100,000 per year, and a prevalence of 13,000 in Australia. Most patients experience frequent diarrhoea with blood and/or mucus in the stools. Others alternatively may present with cramps and intermittent blood in the faeces. This debilitating disease has been managed by various means including surgery and dietary measures, as well various medical options, including mesalazine.

Up to now oral mesalazine has only been available on the Australian market in the form of 250mg tablets. With a dosage range of up to 3g daily, this necessitates taking some 12 tablets daily and with that, some obvious compliance issues.

Orphan Australia is pleased to announce the registration of Salofalk granules for the treatment of acute ulcerative colitis of mild to moderate severity. Salofalk granules, presented as 500mg and 1g sachets in packs of 100s, will be available and PBS Listed from August 1st 2002.

The vanilla-flavoured granule formulation is easy to swallow and allows for simpler dosing thereby improving compliance, particularly with the larger doses of mesalazine needed to manage this condition. The unique layered granule formulation both delays release of mesalazine until the granules reach the higher pH ileal-caecal region of the GI tract, and prolongs it over several hours. Furthermore the mesalazine granules allows uniform distribution over the inflamed intestinal mucosa, systemic absorption is low, reducing potential side effects.

Professor Peter Gibson, of the Box Hill Hospital and President-elect of the Gastroenterological Society of Australia, adds: "Salofalk granules, in more sensible packaging amounts, are an excellent innovation that should improve patient acceptance and compliance. They enable clinicians to treat patients with the higher doses in line with current medical research and practice of up to 3g in active disease, without patients having to take large numbers of tablets".

For more distal forms of the disease, Orphan Australia is also pleased to announce the registration of Salofalk enemas. These will be available in 2g in 60mL and 4g in 60mL presentations, both with 7 enemas per box on private prescription. Orphan Australia has made these enemas available since October 1997 under the Special Access Scheme.

Salofalk enemas are indicated in the treatment of acute ulcerative colitis of mild to moderate severity and for the maintenance treatment of ulcerative colitis.

Each enema bottle is individually vacuum-sealed and airtight, optimising drug stability and therefore, efficacy, for a 2-year shelf life - without refrigeration. Featuring a lubricated, flexible applicator, the unique concertina design of the rectal enema facilitates administration without mess, and the one-way valve mechanism prevents flow-back of the mesalazine suspension into the bottle.

For more information on these products contact Orphan Australia via the contact numbers or e-mail listed below.