A Botanical Drug for Social Phobia

Information

  • Research Project
  • 6405834
  • ApplicationId
    6405834
  • Core Project Number
    R44AT000460
  • Full Project Number
    1R44AT000460-01A1
  • Serial Number
    460
  • FOA Number
  • Sub Project Id
  • Project Start Date
    9/7/2001 - 23 years ago
  • Project End Date
    10/31/2002 - 22 years ago
  • Program Officer Name
    PEARSON, NANCY
  • Budget Start Date
    9/7/2001 - 23 years ago
  • Budget End Date
    10/31/2002 - 22 years ago
  • Fiscal Year
    2001
  • Support Year
    1
  • Suffix
    A1
  • Award Notice Date
    9/6/2001 - 23 years ago

A Botanical Drug for Social Phobia

DESCRIPTION (provided by applicant): 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. PROPOSED COMMERCIAL APPLICATION: 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.

IC Name
NATIONAL CENTER FOR COMPLEMENTARY &ALTERNATIVE MEDICINE
  • Activity
    R44
  • Administering IC
    AT
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    292541
  • Sub Project Total Cost
  • ARRA Funded
  • CFDA Code
    213
  • Ed Inst. Type
  • Funding ICs
    NCCAM:292541\
  • Funding Mechanism
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    ANCILE PHARMACEUTICALS, INC.
  • Organization Department
  • Organization DUNS
  • Organization City
    SAN DIEGO
  • Organization State
    CA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    92121
  • Organization District
    UNITED STATES