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  • 1.  IND scope: dosage form or indication driven?

    This message was posted by a user wishing to remain anonymous
    Posted 13-Feb-2019 15:00
    This message was posted by a user wishing to remain anonymous

    We are debating whether a clinical study can be run under one of two open IND's.  One IND is for an IR formulation, but has a very specific indication.  The other IND is for an XR formulation and has a broad indication.  Both are for the same API.  Can a sponsor run a clinical study with either type of dosage form in the IND that has the proper indication? in other words, can an IR dosage form be submitted to the IND with the broader indication?  and, is there anywhere in the guidances that elaborates on this topic?
    Thanks for any input on this.


  • 2.  RE: IND scope: dosage form or indication driven?

    This message was posted by a user wishing to remain anonymous
    Posted 14-Feb-2019 08:13
    This message was posted by a user wishing to remain anonymous

    Your question is slightly confusing and perhaps not phrased in a right way.
    Here is my preliminary response to your question based on my understanding:
    As an example, If your clinical study pertaining to broader indication (i.e. targeting broader indication or seeking approval for this broad indication), and wish to use XR formulation, then your IND for XR formulation is where the study protocol should be submitted.

    If your clinical study targeting a specific indication and wish to use IR formulation, then you must file the study protocol to the  IND for IR formulation. Please check your two study protocols (i.e. one for specific and the other for broad indication) and see under dosage information section, what formulation is being used for which indication. Then XR formulation study protocol goes to XR formulation IND and likewise the study protocol that uses IR formulation should be submitted to the IR IND.
    You should consult with your clinician on this. The pre-IND work should have determined what formulation is appropriate for which indication.
    Original Message


  • 3.  RE: IND scope: dosage form or indication driven?

    Posted 14-Feb-2019 08:30
    As you describe it, my strategy would be file the protocol to the broad indication with XR formulation IND, but cross-reference the protocol from the IR dosage IND without submitting the protocol to that IND. However, this is where your FDA PM could help a lot. The way they think about it is not only whether the protocol is filed to a relevant IND but how can we do this without confusing the review team. I think my suggestion would achieve that.

    What is not clear from your question is whether you intend to file an NDA with the IR dosage form if development is successful.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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    Original Message


  • 4.  RE: IND scope: dosage form or indication driven?

    Posted 14-Feb-2019 10:01
    An IR and a XR formulation are 2 different products (regardless of API) so you can't switch products between the 2 INDs.  You would need to amend the IND to include either dosage form in the studies for the broader indication.

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    Michael Hamrell, Ph.D., RAC, FRAPS
    Huntington Beach CA
    United States
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    Original Message


  • 5.  RE: IND scope: dosage form or indication driven?

    Posted 16-Feb-2019 10:21
    Thanks! you have confirmed my assumptions on how to handle this.

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    Beth Burnside
    Managing Member, Lowery Creek Consulting, LLC
    Kilmarnock VA
    United States
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    Original Message


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