Phase I of this fast-track SBIR proposal is a pilot Phase 2a study of a proprietary botanical drug product ANPH 102, for the indication of social anxiety disorder (social phobia). This trial will provide definite measurable milestones that upon successful completion will allow the initiation of a larger scale, Phase 2b dose-ranging study. Ancile pharmaceuticals Inc. was found in 1998 to develop important new botanical therapeutics using the newly (1997) opened FDA path for obtaining approval of a botanical drug under a New Drug Application. While developing and extensively characterizing a botanical product to meet the high standards needed for an IND allowance, Ancile identified pharmacological activity previously unreported in the literature. This previously unknown activity suggest likely utility in addressing social anxiety disorder, a disease that represents a significant degree of psychiatric morbidity in the American populace. The specific information concerning efficacy and safety gleaned from this investigation (for which an IND was allowed 11/99) will be the basis for the decision to move forward with further activities along this new path to approval for the use of ANPH 102 as an ethical drug.
The market for therapeutics addressing social phobia is expanding at a rapid rate. Wider practitioner and public knowledge of this condition has increased demand for well-tolerated treatments in an environment where only one entitiy has approval for this indication. Additionally, increasing attention has been given to the poor formulation/standardization of current botanical dietary supplements. An FDA approved phytotherapy for social phobia will likely enjoy significant commercial success.
