Helping overcome sleep apnea

Helping overcome sleep apnea

Helping overcome sleep apnea

Cortex Pharmaceuticals Inc has announced top-line results from an exploratory clinical study with its AMPAKINE compound, CX1739 in subjects with sleep apnea. The study enrolled 20 relatively healthy adults with moderate-to-severe obstructive sleep apnea, 16 of which were administered a single oral dose of CX1739 and 4 of which received matching placebo for one night. The objective of the study was to further explore safety and tolerability in the sleep apnea population, as well as to assess putative efficacy of CX1739 on a range of sleep apnea parameters assessed by overnight polysomnography.

The results from this pilot study are encouraging, and warrant undertaking a larger clinical study to better understand the sleep apnea patient population most responsive to the treatment of CX1739.

The study demonstrated that selected oxygen saturation parameters were statistically improved by one dose of CX1739, but the interpretation of these results was complicated by a reduced sleep time during the night following drug treatment. CX1739 did not reduce the mean apnea/hypopnea index (AHI; frequency of apnea or hypopnea events per hour of sleep). However, in the AHI responder analysis, defined as a greater than 40% reduction in the AHI, three subjects (20%) in the CX1739 treatment group were responders, and there were no responders in the placebo group. Furthermore, CX1739 significantly (p

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