RespireRx Pharmaceuticals Inc, which is developing a dronabinol-based drug to treat obstructive sleep apnea (OSA), and ResolutionRx Ltd, an Australian subsidiary of RespireRx, have entered into a series of bilateral agreements to transfer the RespireRx pharmaceutical cannabinoid program to ResolutionRx and establish it as an operating company.
“Since the incorporation of ResolutionRx at the beginning of this year, it has been our intention to restructure RespireRx by creating a fully operational, cannabinoid drug research and development entity in Australia that will have adequate capital to conduct its strategic and operational plans,” says Jeff Margolis, co-CEO and senior financial officer of ResolutionRx and chief financial officer of RespireRx, in a release.
ResolutionRx was formed in Australia in January by RespireRx as an unlisted public company. RespireRx has contributed by sublicense and license with ResolutionRx, its cannabinoid drug development program subject to certain liabilities. ResolutionRx will now engage in the research and development associated with that program, initially for the development of a new formulation of dronabinol for use in a phase 3 clinical trial and the filing of regulatory approval for the treatment of OSA.
Dronabinol, a synthetic version of ∆-9-THC, a naturally occurring substance in the cannabis plant, has already demonstrated significant improvement in the symptoms of OSA in two phase 2 clinical trials. OSA impacts an estimated 29.4 million people in the United States and has been linked to increased risk for hypertension, heart failure, depression, and diabetes. There are no approved drug treatments for OSA.
Because dronabinol is already FDA-approved for the treatment of AIDS-related anorexia and chemotherapy-induced nausea and vomiting, RespireRx and ResolutionRx further believe that its repurposing strategy would only require, in the United States, approval by the FDA of a 505(b)(2) new drug application, an efficient regulatory pathway that allows the use of publicly available data.