Shire To Develop Galantamine For Chronic Fatigue Syndrome

Shire Pharmaceuticals will develop its acetylcholinesterase inhibitor,galantamine, for the treatment of chronic fatigue syndrome, the poorly-characterized disorder also known as myalgic encephalitis or "yuppie flu." The compound is already in Phase III trials for Alzheimer's disease.

There is evidence that CFS sufferers have reduced levels of acetylcholine, and early trials have suggested that galantamine can relieve the symptoms of the disorder. Shire plans to conduct two Phase II studies to assess the drug's potential in CFS. The first trial, GAL-IV-201, is due to start this month and will enroll 300 patients. Four doses of galantamine will be compared with placebo over 16 weeks. The second study, GAL-IV-202, will involve 60 patients and look for the maximum tolerated dose of galantamine. It is due to start in September.

The primary endpoint will be a change in fatigue measured by Clinician's Global Impression of Change, while secondary endpoints will include sleep disturbance, fibromyalgia, cognitive impairment, change in free stress hormone (cortisol) output and quality of life. Shire expects that the results of these trials will be available in late-1998, and a product could be launched in 2001. The firm has a proprietary position for the use of cholinesterase inhibitors in CFS.