Zogenix (ZGNX)

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Pernix Launches Zohydro® ER with BeadTek™
Published: May 4, 2015 8:00 a.m. ET
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New Formulation Maintains 12-Hour Efficacy to Treat Patients Suffering from Chronic Pain



MORRISTOWN, N.J., May 04, 2015 (BUSINESS WIRE) -- Pernix Therapeutics Holdings, Inc. PTX, +4.55% 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, prov
ides a valuable option for patients already taking a scheduled medication for pain relief.



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