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Frontage Completes Phase I Botanical Drug Study

Marks step in the sponsor’s path for FDA approval

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Frontage Laboratories, Inc. has completed a Phase I study for a client in China. The trial was conducted at the Frontage Clinical Center in Hackensack, NJ and examined the safety and tolerability of a botanical/plant-derived agent in softgel capsules. This Phase I study marks a significant step for the sponsor’s path toward U.S. FDA approval.

The trial enrolled 30 healthy volunteers in an open-label, single-dose, dose-escalation study. According to the study sponsor, it was completed with “highly efficient project management skills and can-do attitude,” and indicated a desire for future collaboration with Frontage.

The global market for botanical and plant-derived drugs is expected to reach $32 billion in 2013, with a five-year compound annual growth rate of 11%, according to a recent market research report, “Botanical and Plant-Derived Drugs: Global Markets” from BCC Research.

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