Phase II Multi-Center Study Begins on Saw Palmetto
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.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.