Dive Brief:
- Data from the Phase 2 PACE study, published in the journal Sleep, showed that the synthetic version of delta-9 THC (tetrahydrocannabinol), dronabinol, improves apnea and daytime sleepiness in patients with obstructive sleep apnea.
- In the study, carried out at Northwestern Medicine and the University of Illinois at Chicago (UIC), 73 people with moderate or severe sleep apnea were given a low (2.5 mg) or high (10 mg) dose of dronabinol or placebo for six weeks. UIC has licensed dronabinol intellectual property to RespireRx Pharmaceuticals, Inc.
- Patients treated with 10 mg dronabinol had a statistically significant lower frequency of apneas or hypopneas during sleep (apnea/hypopnea index reduced by 12.9 units; p=0.003), decreased subjective sleepiness (Epworth Sleepiness Scale score reduced by 3.8 points; p=<0.0001) and greater overall treatment satisfaction compared with the placebo group. Sleep apnea was 33% less severe with dronabinol compared with fully-compliant continuous positive airway pressure.
Dive Insight:
Obstructive sleep apnea is usually treated using a continuous positive airway pressure (CPAP) device, but this can be cumbersome, and compliance isn't always that good, with patients often only using it for four hours a night.
"The CPAP device targets the physical problem but not the cause," said co-lead author Phyllis Zee, director of the Northwestern Medicine Sleep Disorders Center. "The drug targets the brain and nerves that regulate the upper airway muscles. It alters the neurotransmitters from the brain that communicate with the muscles. Better understanding of this will help us develop more effective and personalized treatments for sleep apnea."
The researchers stated in the paper that "These findings support the therapeutic potential of cannabinoids in patients with obstructive sleep apnea. Larger scale clinical trials will be necessary to clarify the best potential approaches to cannabinoid therapy in obstructive sleep apnea."
Sleep apnea affects around 30 million people in the U.S., and the pauses in breathing during sleep can raise the risk of heart disease, diabetes, sleepiness, cognitive impairment and accidents. There is currently no approved drug treatment for sleep apnea, and this study is the largest and longest randomized, controlled trial to test a medicine for the condition.
Dronabinol, approved by the Food and Drug Administration two and half decades ago to treat nausea and vomiting in chemotherapy, is in Phase 2 with RespireRx for obstructive sleep apnea. RespireRx is also developing CX1739 for chronic and post-surgical central sleep apnea; CX717 in opioid-induced respiratory depression; and CX1942 in drug-induced respiratory depression.
"The PACE study results validate our previous Phase 2a clinical trial as well as our business focus on developing new treatments for respiratory disorders for which there are no available drug therapies," said Arnold Lippa, CEO and executive chair of RespireRx.