|Pernix Launches Zohydro® ER with BeadTek™|
New Formulation Maintains 12-Hour Efficacy to Treat Patients Suffering from Chronic Pain
MORRISTOWN, NJ – (BUSINESS WIRE) – May 04, 2015 – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced that the new formulation of Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek™ is now available in U.S. pharmacies. On January 30, 2015, the U.S. Food and Drug Administration (FDA) approved this updated formulation that features BeadTek, a technology encompassing an indistinguishable mix of inactive beads, active immediate-release hydrocodone beads and active extended-release hydrocodone beads. Zohydro ER with BeadTek delivers an extended release of hydrocodone that provides 12-hour dose duration. When taken as directed, the inactive beads contained in Zohydro ER with BeadTek remain inert. The inactive beads dissolve independently of the active hydrocodone beads and are designed not to change the 12-hour release properties of the medication when taken as directed. However, when crushed and dissolved in liquids or solvents, the inactive beads are designed to immediately form a viscous gel.
“Zohydro ER with BeadTek represents an advancement for clinicians and their patients living with, chronic pain, demonstrating effective relief over the 12-hour dose duration.” said Srinivas Nalamachu, MD, president and medical director, International Clinical Research Institute, Overland Park, Kansas and lead author of a clinical study evaluating the long-acting pain relief of Zohydro ER. “Research demonstrated significant rates in pain reduction with no pattern of end-of-dose failure, as well as significantly improved disability scores in patients taking Zohydro ER with BeadTek.”
Zohydro ER with BeadTek is 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 does not contain acetaminophen, unlike many immediate-release hydrocodone products, reducing the risk for potential liver toxicity due to overexposure of acetaminophen. Zohydro ER with BeadTek will be available in strengths 10 mg, 15mg, 20mg, 30mg, 40 mg and 50 mg.
“Zohydro ER is an ideal strategic fit for Pernix, having tremendous synergy with our existing CNS franchise. It also represents a major step forward in our strategy to expand our commercial reach, and we expect it to create significant value for our shareholders,” said Douglas Drysdale, Chairman, President and Chief Executive Officer of Pernix Therapeutics. “Adding Zohydro ER with BeadTek strengthens our specialty product portfolio and brings the proven clinical benefits of Zohydro ER to patients suffering with chronic pain in need of around-the-clock opioid therapy.”
As part of the acquisition, announced on March 10, 2015, Pernix has retained key members of Zogenix’s commercial team, who will oversee the sales and marketing of Zohydro ER with BeadTek, most notably the approximately 100-person sales team. The new Pernix Pain Management sales team will immediately promote both Zohydro ER with BeadTek and Silenor®. Approximately two-thirds of patients experiencing chronic pain report having poor or unrefreshing sleep. Silenor, the only non-scheduled, non-addictive prescription medication for insomnia, provides a valuable option for patients already taking a scheduled medication for pain relief.
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 114 million prescriptions in 2014. 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.
For more information on Zohydro ER with BeadTek including important safety information and the full prescribing information, visit www.zohydroer.com
LIMITATIONS OF USE
Zohydro ER is not indicated as an as needed (prn) analgesic.
Please see the Zohydro ER full prescribing information for the complete boxed warning and safety information.
IMPORTANT SAFETY INFORMATION
Zohydro ER has warnings for: interactions with CNS depressants; elderly, cachectic, debilitated patients, and those with chronic pulmonary disease; hypotensive effects; patients with head injury or increased intracranial pressure; and concomitant use of CYP3A4 inhibitors may increase opioid effects. Please see full prescribing information for the complete warning information.
Potential serious adverse events caused by opioids include addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; interactions with other CNS depressants; hypotensive effects; gastrointestinal conditions, and seizures. The most common adverse reactions associated with Zohydro ER (≥2%) include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, peripheral edema, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain, and tremor. With intravenous abuse, the inactive ingredients in Zohydro ER can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
Silenor is a prescription sleep medicine that is used to treat people with insomnia who have trouble staying asleep. Staying asleep is the number one reported sleep problem of people with insomnia. Instead of putting you to sleep, Silenor helps you stay asleep during the night. It also helps to keep you from waking too early in the morning. Silenor does this by working with the wake-promoting mechanism of your body’s natural sleep-wake cycle. Silenor is the only nonscheduled, non-addictive prescription medicine indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. Silenor has minimal next-day residual effects, even in elderly patients and has shown no evidence of physical dependence or withdrawal symptoms.
For more information on Silenor including important safety information and the full prescribing information, visit www.silenor.com
About Pernix Therapeutics
To learn more about Pernix Therapeutics, visit www.pernixtx.com.
Zohydro® ER is a registered trademark of Pernix Ireland Pain Limited.
Pernix Therapeutics Holdings, Inc.