Under the agreement, IntelGenx will be responsible for the research and development of the product, including clinical studies and will develop the product as an oral mucoadhesive tablet based on its proprietary AdVersa® controlled-release technology, the company told us in a statement.
Next steps are FDA discussion, scale-up of the formulation, and efficacy and safety studies, Edward Miller, Director, IR & Corporate Communications, explained.
Tetra will have exclusive rights to sell the product in North America with a right of first negotiation for outside the US and Canada. The company will make non-refundable exclusive negotiation payment to IntelGenx, an upfront payment, in addition to set milestone payments.
Phase I studies have been completed and showed the mucoadhesive tablet formulation allowed for enhanced bioavailability of the synthetic THC and reduced circulatory levels of 11-OH THC.
“These ph I results may translate in 1) increased efficacy and 2) reduced side effects, which remain to be proven clinically,” Miller said.