The poor tolerance and long-term adherence to CPAP, as well as the limitations of mechanical devices and surgery, make discovery of therapeutic alternatives clinically relevant and important. RespireRx’s translational research results demonstrate that dronabinol has the potential to become the first drug treatment for this large and underserved market.
Based on the preclinical studies of Dr. David Carley of the University of Illinois Chicago (UIC), RespireRx conducted a 21-day, randomized, double-blind, placebo-controlled, dose escalation Phase 2A clinical study in 22 patients with OSA. Dronabinol produced a statistically significant reduction in Apnea-Hypopnea Index (AHI), the primary therapeutic end-point, and was observed to be safe and well tolerated, with the frequency of side effects no different from placebo.
Subsequently, Dr. Carley, along with his colleagues at UIC and Northwestern University, completed a Phase 2B multi-center, double-blind, placebo-controlled clinical trial of dronabinol in patients with OSA. This study, named “Pharmacotherapy of Apnea with Cannabimimetic Enhancement” (“PACE”) replicated the earlier Phase 2A study. In a dose-dependent fashion, night-time treatment with 2.5mg and 10mg of dronabinol, significantly reduced AHI during sleep, compared to placebo, in 56 evaluable patients with moderate to severe OSA who completed the study. Additionally, treatment with 10mg of dronabinol significantly improved daytime sleepiness as measured by the Epworth Sleepiness Scale and achieved the greatest overall patient satisfaction. As in the previous Phase 2A study, dronabinol was observed to be safe and well tolerated, with the frequency of side effects no different from placebo.
Based on the significance of these studies, we intend to continue development of dronabinol for the treatment of OSA, with the intention of submitting a New Drug Application (NDA) to the FDA.