Regulatory Open Forum

 View Only

  • 1.  Fixed Dose Combination Product

    This message was posted by a user wishing to remain anonymous
    Posted 06-Sep-2018 11:56
    This message was posted by a user wishing to remain anonymous

    My company is planning to conduct a study for a combination product.  The one product has been on the market for over ten years and owned by another company, and our product is nearing completion of a phase 2b study.  I do not have any experience with fixed dose combination products.  

    Do you have any advice or points that I need to consider?

    Thank you for your help!


  • 2.  RE: Fixed Dose Combination Product

    Posted 06-Sep-2018 17:55
    For any fixed combination trial it is recommend to consult with FDA within the pre-IND stage for any doubts and queries. If you are asking for Regulatory Considerations for fixed dose combination products, here are some important factors:

    -Information necessary to justify the proposed combination
    • Rationale supporting the proposed combination and dose
    • Animal toxicity data for separate drugs
    • Drug-drug interaction data, if applicable
    -Contribution of efficacy for each agent (investigational/approved) should be demonstrated

    -Selection of appropriate drug combination

    -If one component in combination is already approved, existing safety data for the approved component may be considered sufficient (if provided the same drug dose, formulation, delivery method is being developed in the combination product)

    -Right of reference to other sponsor's IND/NDA (approved)

    -If its for dual indications
    • It is expected the development program will be designed to meet the current regulatory requirements for each indication
    • separate IND is recommended for each indication
    CMC
    • Quality standards for each active ingredient and dosage form
    • Stress studies: lack of interaction between ingredients
    • Drug release information (dissolution)
    • Stability data: long term and short term under high temperature and/or humidity
    • References/data supporting excipients
    • Manufacturing processes for active ingredients and dosage form

    ------------------------------
    Amit Jain
    United States
    ------------------------------

    Original Message


  • 3.  RE: Fixed Dose Combination Product

    Posted 07-Sep-2018 23:32
    Another key issue is whether FDA will insist you do a "factorial" study where you end up with more arms in your study than would be typical for a single-entity drug. For more on this, see my presentation entitled "Strategies in Designing Clinicals for Fixed-Combination Drugs",
    available at: https://www.slideshare.net/mswit/strategies-in-designing-clinicals-for-fixedcombination-drug

    Good luck,
    Michael

    ------------------------------
    ______________________________________________
    Michael A. Swit, Esq.
    Law Offices of Michael A. Swit
    San Diego, CA
    e: mswit@fdacounsel.com
    m: 760-815-4762
    www.fdacounsel.com

    Note: all postings by me on this forum represent my personal views and are not necessarily those of my law firm or any of our clients. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

    Please follow me on LinkedIN and Twitter:

    https://www.linkedin.com/in/michaelswit/
    https://twitter.com/FDACounsel
    ------------------------------

    Original Message


Related Content