RespireRx Pharmaceuticals Inc. Announces Positive Results from Phase 2B PACE Study Conducted by the University of Illinois Dronabinol Reduces Symptoms of Obstructive Sleep Apnea
BY Market Wire
— 8:00 AM ET 12/23/2016
GLEN ROCK, NJ -- (Marketwired) -- 12/23/16 -- RespireRx Pharmaceuticals Inc. (RSPI) ("RespireRx" or the "Company"), is pleased to announce positive results of the PACE (Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial conducted by Dr. David Carley and colleagues at the University of Illinois at Chicago and Northwestern University. The PACE trial, a Phase 2B study of dronabinol for the treatment of obstructive sleep apnea ("OSA"), clearly demonstrates that dronabinol significantly improves the primary outcome measures of Apnea Hypopnea Index ("AHI"), daytime sleepiness as measured by the Epworth Sleepiness Scale ("ESS") and overall patient satisfaction as measured by the Treatment Satisfaction Questionnaire for Medications ("TSQM").
In a dose dependent fashion, treatment with 2.5 mg and 10 mg dronabinol once a day at night significantly reduces the Apnea Hypopnea Index ("AHI"), a measure of breathing abnormalities during sleep, in 56 patients with moderate to severe OSA who completed the study. Of these, 17 received placebo, 19 received the 2.5 mg dose and 20 received the 10 mg dose. Compared to average baseline AHI values of 26 + 12, six weeks of dronabinol administration to moderate to severe OSA patients reduced AHI values, compared to placebo, by 9.7 + 4 for the 2.5 mg dose and 13.2 + 4 for the 10 mg dose (p=.02 and p=.001, respectively, compared to control). Furthermore, treatment with 10 mg dronabinol significantly improved daytime sleepiness as measured by the ESS (p = 0.0001, compared to placebo) and achieved the greatest overall patient satisfaction with treatment (p=.02) as measured by the TSQM.
Arnold Lippa, Ph.D., Chief Scientific Officer and Executive Chairman commented, "We congratulate Dr. Carley and his colleagues at both the University of Illinois at Chicago and Northwestern University for the successful completion of the PACE trial. These positive results clearly demonstrate the potential for dronabinol to treat OSA, a serious condition affecting millions of people with very few viable treatment options. We plan to move forward with the development of dronabinol in OSA, and plan to meet with the FDA for a Special Protocol Assessment ("SPA") to finalize the Phase 3 study required for approval using both fast track and breakthrough designations from the FDA to facilitate the development path."
James S. Manuso, Ph.D., President, Chief Executive Officer and Vice Chairman stated, "We are very excited with the possibility of bringing to market the first drug treatment for OSA. We can now envision a small molecule, easy to use, oral medicine for OSA patients as an alternative to CPAP (continuous positive airway pressure) devices, surgery and other methods used to treat this underappreciated disease, which has such enourmous costs to society."
"We look forward to discussing with investors the results of this trial at upcoming conferences."
