FDA News

FDA Okays Samaritan's Cushing's SP-6300 IND and Clears Phase II Study

(Jan 03, 2008)-- Samaritan Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has completed its regulatory review of Samaritan's IND (Investigational New Drug) application for Cushing's syndrome SP-6300 and declared it has not identified any deficiencies in its IND filing. Accordingly, Samaritan can proceed with its proposed Phase II clinical study of Cushing's syndrome SP-6300's efficacy in patients experiencing Hypercortisolism.

Dr. Janet Greeson, CEO of Samaritan stated, ``We are extremely pleased the FDA has cleared our IND. We have high hopes for Cushing's syndrome SP-6300's ability to modulate pathologically high cortisol levels since it demonstrated proof of concept as a cortisol modulator in Samaritan's Phase II clinical HIV trial. We believe SP-6300 can offer a unique and novel approach for a broad range of applications where cortisol levels get out of control.''

Cortisol is important as it performs vital tasks in the body but when it is too high or too low, it can cause physical problems. It helps maintain blood pressure and cardiovascular function, reduces the immune system's inflammatory response, balances the effects of insulin in breaking down sugar for energy, and regulates the metabolism of proteins, carbohydrates, and fats.

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