- 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
MORRISTOWN, N.J., Sept. 09, 2016 (GLOBE NEWSWIRE) -- 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.
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 |
| Poster: | #41 |
| Symposium Title: | Beyond Chronic Pain in the Opioid-Managed Patient – Addressing |
| Comorbid Sleep and Psychiatric Disorders | |
| Date: | Wednesday, September 7, 2016 |
About Zohydro ER with BeadTek™ Zohydro ER with BeadTek is an extended-release form of hydrocodone indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zohydro ER with BeadTek does not contain acetaminophen, unlike many immediate-release hydrocodone products, reducing the risk for potential liver toxicity due to overexposure of acetaminophen. The active ingredient, hydrocodone, is the most commonly prescribed opioid in the U.S., with over 90 million prescriptions in 2015. Zohydro ER with BeadTek is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate containing technology that contains an inactive ingredient that immediately forms a viscous gel when crushed and dissolved in liquids or solvents. As covered by the ‘760, ‘982, ‘201, ‘499, ‘200 and ‘619 patents, no adjustment in starting dose for Zohydro ER is required for patients with mild or moderate hepatic impairment. Zohydro ER with BeadTek is available in strengths 10mg, 15 mg, 20mg, 30 mg, 40mg, and 50mg.
For more information on Zohydro ER with BeadTek including important safety information and the full prescribing information, visit www.zohydroer.com .
About Pernix Therapeutics Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and pain management, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its two Pernix sales forces and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc.
To learn more about Pernix Therapeutics, visit www.pernixtx.com .
Zohydro ® ER is a registered trademark of Pernix Therapeutics Holdings, Inc. BeadTek™ is a trademark used by Pernix under license.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “target” or similar expressions are forward-looking statements. These statements reflect the Company’s current views, expectations and beliefs concerning future events. These forward-looking statements include statements regarding: planned development activities relating to a next-generation version of Zohydro ER, estimated annualized cost savings and potential for future revenue growth and profitability resulting from the restructuring of our salesforce and the recent management changes, increased usage of our three core products, Treximet, Silenor and Zohydro ER, increased usage of our prescription fulfillment program, Pernix Prescriptions Direct, and improved financial flexibility through a possible restructuring of our debt and other potential alternatives. The inclusion of forward-looking statements should not be regarded as a representation by Pernix that any of its plans will be achieved. Investors should note that many factors, including the risks and uncertainties inherent in Pernix’s business, as more fully described in Pernix’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent filings with the SEC, could affect the Company’s future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in this press release. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
CONTACT Investor Relations Matthew P. Duffy, 212-915-0685 LifeSci Advisors, LLC matthew@lifesciadvisors.com
