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Titan Pharmaceuticals Inc. Message Board

  • settoplunge settoplunge Mar 19, 2013 8:38 AM Flag

    Draft Questions to the Committee

    1. DISCUSSION: Please comment on whether the Applicant conducted adequate dose
    exploration in the development program to determine the most effective dose.
    a. VOTE: Do the data from the clinical trials provide substantial evidence of effectiveness
    of Probuphine for the maintenance treatment of opioid dependence?
    2. DISCUSSION: Please comment on the Applicant’s assessment of the safety aspect of
    Probuphine in general, as well as on safety concerns specific to the placement and removal of
    the implants.
    a. VOTE: Has the Applicant adequately characterized the safety profile of Probuphine in
    this patient population?
    3. VOTE: Is the Risk Evaluation and Mitigation Strategy (REMS) proposed by the Applicant,
    which consists of restricted distribution and a training/certification program for healthcare
    professionals who will implant the product, adequate to address the risks of potential
    complications associated with the implantation procedure and abuse, misuse, and accidental
    overdose. Include in your deliberations any concerns related to the proposed model of care
    and training/certification program.
    4. DISCUSSION: Please discuss whether the absence of any information on each of the
    following matters should be considered a critical deficiency in the application:
    a. the potential for removal of the implants by non-medical personnel for the purpose of
    diversion.
    b. the potential for long-term exposure to the components of the rods if an individual never
    has the implants removed.
    c. the potential for patients to require implantation into an arm which has received an
    implant previously in order to remain on treatment, which would necessitate
    identification of multiple implantation sites per arm, or use of previously implanted sites.
    5. VOTE: Based on the data presented and discussed today, do the efficacy, safety, and riskbenefit
    profile of Probuphine support the approval of this application?

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