RespireRx Pharmaceuticals Inc.
RespireRx is developing a pipeline of new drug products based on broad patent portfolio related to pharmaceutical cannabinoids, including dronabinol, a synthetic version of ∆-9-tetrahydrocannabinol (“∆-9-THC”), a naturally occurring substance in the cannabis plant that acts upon the nervous system’s endogenous cannabinoid receptors. RespireRx is developing dronabinol for the treatment of OSA, a serious respiratory disorder that impacts an estimated 29.4 million people in the United States according to the American Academy of Sleep Medicine. OSA has been linked to increased risk for hypertension, heart failure, depression, and diabetes, and has an annual economic cost in the United States of $162 billion according to the AASM. There are no approved drug treatments for OSA. Pending the completion of a new formulation of dronabinol and an intended pre-IND meeting with the FDA, RespireRx believes that it will be able to commence a pharmacokinetic study for the new formulation followed by a Phase 3 clinical study for the treatment of OSA. Because dronabinol is already FDA approved for the treatment of AIDS related anorexia and chemotherapy induced nausea and vomiting, the Company further believes that its re-purposing strategy would only require approval by the FDA of a 505(b)(2) new drug application (“NDA”), an efficient regulatory pathway that allows the use of publicly available data.