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Home Industry News Merck KGaA pulls Sarizotan from development

Merck KGaA pulls Sarizotan from development

23rd June 2006

German pharmaceutical company Merck KGaA has withdrawn Sarizotan from development after unsuccessful phase III clinical trials.

Sarizotan was designed to treat dyskinesia (involuntary turning or twisting movements) experienced by patients with Parkinson’s disease, which can develop after years of treatment with standard anti-Parkinson’s drugs.

In two phase III studies performed in 15 countries with over 1,000 patients, Sarizotan or a matching placebo was administered twice daily. By the study’s design, an observed improvement in symptoms of 25 per cent or more was defined as meeting the primary endpoints necessary for success. Sarizotan failed to meet this, despite earlier successful trials in phase II development.

Had Sarizotan been successful, it would have been the first drug to be approved to treat dyskinesia for Parkinson’s disease patients.

A statement from Merck read: “The Phase III studies in the present design did not confirm the Phase II findings nor the results from preclinical studies. A statistically significant difference of the primary target variable between Sarizotan and placebo could not be demonstrated in these studies.”

“Therefore a filing and launch in this indication will not be possible. Merck does not plan to pursue further development of this compound,” it concluded.

The company said it intended to present the results of the trials at the Movement Disorder Society’s International Congress of Parkinson’s Disease later this year.

Parkinson’s disease is caused by a reduction in the levels of dopamine, a neurotransmitter, in the brain. According to the UK’s Parkinson’s Disease Society, dopamine works in conjunction with acetylcholine to regulate the body’s movement. When this balance is lost, the symptoms of Parkinson’s disease can develop.

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