A Phase III, randomised, placebo-controlled, dose ranging study is due to commence late 2006 in the UK. Diltiazem 1%, 2% and 4% topical cream preparations will be compared with placebo in patients with chronic anal fissure (n=88 completed patients per group).

We expect to complete the trial late 2007.

A pivotal randomised, placebo-controlled study has been designed to evaluate the efficacy of phenylephrine gel in 100 patients with ileal pouch anal anastomosis (IPAA) related faecal incontinence.

We expect to complete the trial late 2007.

Two phase II trials are underway in sporadic and FAP polyp patients.
The trials will give an indication of the optimal EPA dose and look at the potential benefit in FAP patients. Results for both trials are expected 2007.

The results of the phase I 99% free fatty acid EPA trial at St Georges for sporadic polyps has been released. Very promising results warrant further investigation of the use of omega-3's in patients suffering from sporadic polyps.

S.L.A. Pharma is researching the use of Metro 10% to reduce the post operative pain associated with haemorrhoidectomies. Results are expected early 2007.

A US/UK Phase III trial is expected to commence in early 2005.

A recent study with Diltiazem 2% at the Whittington Hospital, London titled 'Changing trends in the Management of Chronic Anal Fissure' is in Scientific Articles, Diltiazem.

Results from a single dose pharmacokinetics study using 10mg Naloxone has shown only low levels in the systemic circulation. The slow release of Naloxone minimises any adverse effects on analgesia.

S.L.A. Pharma has entered into a world wide (excluding Japan) licensing arrangement with Solvay Pharmaceuticals to develop and market Diltiazem and Phenylephrine.

S.L.A. Pharma has entered into a Japanese licensing arrangement with Nisshin Kyorin to develop and market Phenylephrine.

S.L.A. Pharma has entered into a North America licensing arrangement with Solvay Pharmaceuticals to develop and market Diltiazem and Phenylephrine.

S.L.A. Pharma has entered into a Japanese licensing arrangement with Nisshin Kyorin to develop and market Diltiazem.

S.L.A. Pharma has entered into a European licensing arrangement with Gebro Pharma to develop and market Diltiazem and Phenylephrine.