To help extend the lifespan of a profitable prescription drug, Instigator developed and spearheaded the process of creating an OTC version of the product.

The Opportunity

A $30 million prescription product had three years of patent life remaining. Instigator supplied a lifecycle management expert to investigate options to reduce the risk of declining sales.

The Solution

Our expert started at square one: exploring, gathering and analyzing all the options that were available, including AG, own generic, and transitioning to over-the-counter.

We then created a team that developed a P&L model for an OTC option that was half the dose of the lowest currently available. Our model included the cost of clinical studies needed for approval of the OTC version.

Next, Instigator contacted the FDA to request a pre-IND meeting for an RX-to-OTC switch, and received a positive response from the agency. With that note of encouragement, our team enlisted two Key Opinion Leaders to assist in developing and sending the briefing document for the FDA meeting.

This meeting was held with Directors of the OTC, Neurology, and Psychiatry divisions, as well as Key Opinion Leaders and the VP of Regulatory. The meeting was successful, with the FDA providing directions and suggestions that allowed the company to proceed with the steps necessary for the switch to OTC.

To implement the required clinical studies, Instigator’s team lead drew on his extensive industry knowledge to identify and select the ideal CRO, one with extensive experience in Rx-to-OTC switches.

The Results

Studies were initiated on the lower dose OTC form. To defray the costs of the studies and subsequent launch, a partner was identified to co-develop and launch the OTC version upon FDA approval.