SCOLR Pharma has initiated the first of three pivotal trials to evaluate its extended release ibuprofen tablet, with hopes that it will be the first and only 12-hour formulation on the market.
SCOLR announced the plans today, expecting to complete the full arsenal of trials by the end of the first quarter 2008, with a new drug application (NDA) planned for US Food and Drug Administration (FDA) submission in the second half of the year.
The extended release formulation is based on SCOLR's controlled delivery technology (CDT), and will be sold as an over-the-counter (OTC) analgesic, with the company currently estimating the immediate release OTC ibuprofen market to be worth $1bn in the US alone.
The three trials SCOLR is initiating will each enrol 216 subjects, and will look at safety and efficacy of multiple 600mg doses of the extended release formulation for dental pain following extraction of the third molar, multiple doses to compare bioavailability with an immediate release formulation, and a final study to determine the relative bioavailabilty of two ibuprofen formulations under fed and fasted conditions.
Back in April SCOLR announced that it has reacquired the technology for global rights to its ibuprofen products, following Wyeth's termination of a development and licence agreement that gave it global rights to use the CDT platform for all products containing ibuprofen.
At the time, SCOLR said Wyeth's decision was a disappointment but also "a significant opportunity for us." The company would continue preparations for a US approval application, while evaluating various opportunities for the product, including discussions with large pharmaceutical companies that had previously expressed an interest in working with SCOLR to commercialise a variety of extended-release ibuprofen formulations.
"We are optimistic about our ability to advance commercialisation of a 12-hour extended release ibuprofen product," said president and CEO Daniel Wilds. "We believe that multiple clinical trials, real-time stability and scale-up activities provide strong evidence of the commercial viability of our CDT formulation."
With the pivotal trials announced today now kicking off and the 12-hour formulation reaching the final stages of clinical development, SCOLR has indeed pressed ahead with its ibuprofen plans and looks on to FDA approval.