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news.Samaritan Pharmaceuticals has reported that the FDA has completed its regulatory review of the company's investigational new drug application for its drug for Cushing's syndrome and declared it has not identified any deficiencies in its IND filing.
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Samaritan can now proceed with its proposed Phase II clinical study of Cushing’s syndrome SP-6300’s efficacy in patients experiencing hypercortisolism.
Dr Janet Greeson, CEO, said: “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 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 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.