Stock Update (NASDAQ:PTX): Pernix Therapeutics Holdings Inc Announces Positive Phase IV Results of Silenor® vs. Zolpidem Head-to-Head Arousability Study

Pernix Therapeutics Holdings Inc (NASDAQ:PTX), a specialty pharmaceutical company, today announced positive final results from a Phase IV Study assessing the effects of nighttime administration of insomnia treatments, Silenor® 6 mg and zolpidem 10 mg, as well as placebo, on arousability, gait, balance, and cognitive performance, after going to sleep, in healthy male volunteers. These data were presented at the SLEEP 2016 International meeting, which took place on June 14th and 15th in Denver, Colorado.

The study assessed the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective Tmax (time the maximum serum concentrations are observed) in normal healthy adult male volunteers (n=52).  The results of the study demonstrated that Silenor 6 mg was statistically superior to zolpidem 10 mg on the measures studied – arousability, gait, balance, and memory.

John Sedor, Chairman and CEO of Pernix Therapeutics, said, “The results of this head-to-head study further support certain key benefits of Silenor 6 mg.  Pernix is encouraged by these data and the impact they could have on the sleep community and patients.”

The results also indicated that subjects taking Silenor 6 mg did not have impairment on arousability, gait, balance, and cognitive performance, and were comparable to placebo.  Further, in addition to Silenor 6 mg, both placebo groups were also statistically superior to zolpidem on the measures evaluated, indicating that zolpidem subjects had statistically significant difficulty in waking up, with walking and balance and with memory. Finally, there were no differences in efficacy measures between zolpidem 10 mg and Silenor 6 mg, while several measures were significantly improved with Silenor 6 mg versus placebo.

“One of the most interesting findings in the study was that a majority of the subjects in the zolpidem group did not wake up until they were exposed to noise of at least 110 decibels (dB; 64%),” stated Heith Durrence, Ph.D., Sleep Expert and Medical Director at Pernix Therapeutics. “The awakening threshold data indicate that subjects taking zolpidem could have difficulty waking up to noises similar to a jackhammer (average of 100 dB), a potentially serious issue.” (Original Source)

Shares of Pernix Therapeutics closed yesterday at $0.449, down $0.04 or -7.38%. PTX has a 1-year high of $6.44 and a 1-year low of $0.39. The stock’s 50-day moving average is $0.56 and its 200-day moving average is $1.61.

On the ratings front, Pernix has been the subject of a number of recent research reports. In a report issued on May 6, Brean Murray Carret analyst Difei Yang reiterated a Buy rating on PTX, with a price target of $3, which implies an upside of 568.2% from current levels. Separately, on March 16, Oppenheimer’s Akiva Felt downgraded the stock to Hold .

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Difei Yang and Akiva Felt have a total average return of -11.4% and -0.5% respectively. Yang has a success rate of 35.1% and is ranked #3838 out of 3971 analysts, while Felt has a success rate of 33.5% and is ranked #2783.

Pernix Therapeutics Holdings, Inc. engages in the research, development, and manufacture of biopharmaceutical products. It focuses on therapeutics for diseases on central nervous system, neurology, pain, and psychiatry. Its products include treatment of migraine pain and inflammation, insomnia, and depressive disorder. The firm distributes its products under the following brands: Treximet, Silenor, Zohydro ER with BeadTek, and Khedezla.


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