SEC Filings

8-K
PERNIX THERAPEUTICS HOLDINGS, INC. filed this Form 8-K on 02/19/2019
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34 Arousability Study Conclusions • Phase IV study assessing the effects of a nighttime administration of Silenor ® 6 mg, zolpidem 10 mg, and placebo on arousability, gait/balance, and cognitive performance • Assessed the effects of Silenor ® 6 mg, zolpidem 10 mg and matching placebos in 52 normal healthy adult male volunteers • The results, released on June 16 , 2016 , demonstrate: • Silenor ® 6 mg is superior to zolpidem 10 mg on all measures analyzed (arousability, gait, balance, memory) on a statistically significant basis • Subjects taking Silenor ® 6 mg did not have impairment on any of these measures and were comparable to placebo • Silenor ® 6 mg and both placebo groups were superior to zolpidem on all measures • Zolpidem subjects experienced significant impairments, including difficulty waking up and in their ability to walk • A recent Phase IV arousability study demonstrated that Silenor ® was statistically superior to zolpidem when measuring the impairment of arousability , gait / balance and cognitive performance after nighttime administration • The study also showed that nighttime administration of Silenor ® had similar results to placebo on the same measurements Measure Silenor ® 6 mg Zolpidem 10 mg Placebo (two groups) p - value (Silenor ® vs. Zolpidem ® ) Auditory Awakening Threshold (avg) 85 decibel (dB); 17% didn’t wake up prior to maximum tone 103 dB; 64% didn’t wake up prior to maximum tone 85 dB and 78 dB (21% and 6%) p<0.0001 Tandem Walk (avg # steps off beam) 1.3 8.1 1.1 and 1.0 p<0.0001 Tandem Walk (avg time to walk across beam ) 5.0 seconds 6.7 seconds 4.8 and 4.8 seconds p<0.0001 Berg Balance Scale (avg score) 54.5 51.4 55.0 and 55.2 p<0.0001 Free Recall Memory Test (avg words recalled at Tmax and next morning) 7.9 and 6.8 4.8 and 2.2 7.7 and 6.5/ 8.1 and 7.0 p<0.0001 Arousability Study: Positive Results (1) Christopher D, et al. Arousability and fall risk during forced awakenings from nocturnal sleep among healthy males following administration of Zolpidem 10 mg and Doxepin 6 mg: A randomized, placebo - controlled, four - way crossover trial; Sleep, Volume 40, Issue 7; 1 July 2017.