Phase II Multi-Center Study Begins on Saw Palmetto
January 1, 1998 less than 1 minute read
Phase II Multi-Center Study Begins on Saw Palmetto
PharmaPrint, an Irvine, CA-based manufacturer of standardized herbal products, has begun a Phase II multicenter study of a drug derived from saw palmetto berries for treatment of benign prostatic hyperplasia.
If the product is approved by the FDA for treatment of BPH, a prescription drug could be manufactured, says David Sheon, a spokesman for PharmaPrint.
PharmaPrint submitted the saw palmetto investigational new drug application to the federal Food and Drug Administration (FDA) July 31.
The double-blinded, dose-ranged trial will be done at centers in San Diego; Waterbury, CT; Aventura, FL; and Milwaukee. If the Phase II trial succeeds, the company will move to a Phase III trial including about 150 patients to evaluate the efficacy of its saw palmetto-based drug.
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