Pernix Therapeutics (PTX) Presented Poster Focused on Pharmacokinetic Profile of Zohydro ER

September 9, 2016 8:02 AM EDT

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Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company with a focus on Pain and CNS conditions, today announced that the Company presented a poster focused on the pharmacokinetic profile of Zohydro® ER, and sponsored a symposium to discuss treating comorbid sleep and psychiatric disorders in opioid-managed patients at PAINWeek 2016, which is taking place this week in Las Vegas, NV.

  • Company’s Poster Presentation Highlighted Results of Study Evaluating Hepatic or Renal Impairment on the Pharmacokinetics of Zohydro® ER
  • Pernix Also Sponsored a Well-Attended Symposium Focused on Addressing Comorbid Sleep and Psychiatric Disorders in Opioid-Managed Patients

The poster presentation focused on two open-label studies that evaluated the effects of hepatic or renal impairment on the pharmacokinetic profile of Zohydro ER (hydrocodone extended-release, HC-ER), as the impairment of these functions may affect the metabolism and excretion of hydrocodone. One study enrolled subjects with mild, moderate, or severe chronic renal impairment, and the other subjects with mild or moderate hepatic impairment, and both studies also enrolled an arm of healthy control subjects. All subjects received a dose of 20 mg HC-ER. The results of the studies demonstrated that subjects with all assessed severity levels of hepatic or renal impairment were likely to experience slightly higher hydrocodone exposure after HC-ER administration relative to those with no hepatic or renal impairment. Importantly, however, the increase in exposure was modest and should not warrant any starting dose adjustment for impaired patients using Zohydro ER.

“Hepatic and renal function is an important consideration when prescribing opioid pain medications. This poster provides clinical evidence that the starting dose does not need to be adjusted for patients treated with Zohydro ER,” said Errol Gould, PhD Senior Director Medical Affairs for Pernix Therapeutics.

The Pernix-sponsored symposium featured key pain management industry thought leaders, including Jeremy A. Adler, MS, PA-C, Pacific Pain Medicine Consultants, Jeffrey Fudin, PharmD, DAAPM, FCCP, FASHP President and Director, Scientific and Clinical Affairs, REMITIGATE, LLC, and Jay Joshi, MD, DABA, DABA-PM, FABA-PM CEO/Medical Director, National Pain Centers. The program focused on assessing sleep and affective disorders in chronic pain patients, and treatment choices to improve clinical outcomes, enhance quality of life, and mitigate risk of opioid misuse and overdose.

“We are pleased to have such a significant presence at PAINWeek, the largest U.S. pain conference for frontline practitioners,” said John Sedor, Chairman and CEO of Pernix Therapeutics. “This presence highlights our commitment to Pain Care providers and the patients they care for. Pernix remains dedicated to investing in building the value of our core brands, including Zohydro ER with BeadTek, Treximet, and Silenor.”

Pernix at PAINWeek 2016
Poster Title: Effects of Hepatic or Renal Impairment on the Pharmacokinetics of
Extended-Release Hydrocodone
Date:September 8, 2016
Symposium Title:Beyond Chronic Pain in the Opioid-Managed Patient – Addressing
Comorbid Sleep and Psychiatric Disorders
Date:Wednesday, September 7, 2016

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