Strategies That Make a Difference

Novel Switch Strategy and Implementation

Background

Client had identified an opportunity to expand the indications for one of its OTC products by switching an Rx-only indication. But, there was no precedent for doing this.

Key Questions

  • How can we obtain FDA approval for the indication while:
    • Preserving the product as an OTC
    • Obtaining exclusivity
    • Maximizing the commercial opportunity

Our Approach and Output

  • Provided comprehensive strategic and tactical support, from planning through launch, including:
    • Marketing strategy development
    • Issue identification and feasibility assessment
    • Development of the switch rationale
    • Analysis and optimization of the evidence base
    • Development of FDA submission materials
    • Opinion leader management and stakeholder alignment
    • Advisory committee preparation and meeting management
    • Post-approval PR
    • Consumer and professional messaging/communication strategy

Results

  • Unanimous recommendation for approval by the FDA Advisory Committee
  • PR efforts following the advisory committee meeting resulted in a 2 point increase in client's stock price in one day
  • Solidified category leadership
    • #1 brand in the category
    • #1 OTC professional recommendation for indication
    • Succeeded in doubling market share

Client Feedback

"NCI worked seamlessly with our internal commercial, R&D and regulatory teams. You provided us with strategic insight and tactical support we didn't even know we needed and led us through a disciplined process that energized us all. This will no doubt become a case study for best practices in Rx-to-OTC switch in years to come."