Dronabinol (D9-THC, D9-tetrahydrocannabinol) is an oral capsule drug product that is being tested for clinical efficacy in patients with obstructive sleep apnea (OSA). In a recently completed pilot, dose-escalation trial in 22 patients, dronabinol was safe and well-tolerated, and reduced the apnea-hypopnea index score in the moderate-severe OSA patients by about 30%.
Dronabinol is currently in a larger, 120 patient study of OSA being conducted principally by the University of Illinois with funding from a $5 million grant from the NIH. You may find information about this trial here.
RespireRx has licensed the intellectual property rights from the University of Illinois, for the use of cannabinoids, of which Dronabinol is one, for the treatment of sleep related breathing disorders, including OSA.
Dronabinol is already approved in the United States by the FDA for other indications, anorexia associated with AIDS and chemo-therapy induced nausea and vomiting. It is a Schedule III drug (low risk of abuse) and is Medicare Part B reimbursed for its current indications. However, it is not yet approved for OSA.
Sleep apnea is a very large, underserved market with no available pharmaceutical treatments. There are an estimated 18 million sleep apnea patients in the United States and the condition is considered to be under-diagnosed. Although there are several types of sleep apnea, OSA is the most prevalent form. A medical device called constant positive airway pressure (CPAP) is the only approved treatment available for sleep apnea. CPAP devices typically consist of a mask which covers the nose and mouth that is connected to an air pump. While a CPAP mask can be effective in reducing sleep apnea, for a variety of reasons, about half of patients initially prescribed its use fail to continue to use the device. This poor compliance in the use of CPAP and other types of air pressure devices suggests there is clearly a market for a safe, effective pharmaceutical in the treatment of sleep apnea.