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
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
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?
#3 in regard to the REMS, didn't they say at the CC that it was a draft and would be working with the FDAs guidance to complete it to the satisfaction of the FDA? This had some questions raised in the summary, but if it can be adapted by working with the FDA... why would it even be an issue here?
Number 5 is the only one that deserves a serious answer. Is it effective? Yes. Is it safe? Yes. Risk v. Benefits support approval? Yes. 14 to 21 days later......approval.....fiscal quarter 4 revenues...?
To the bashers: (not to settoplunge)
THANK YOU FOR A MOST PROFITABLE DAY....and CAN YOU COME BACK TOMORROW and DO IT AGAIN?