MORRISTOWN, N.J. — Pernix Therapeutics Holdings Inc. has rolled out a new formulation of Zohydro Extended-Release Capsules (hydrocodone bitartrate, CII) with BeadTek technology, to U.S. pharmacies.

Pernix said Monday that Zohydro ER with BeadTek is available in strengths 10 mg, 15 mg, 20 mg, 30 mg, 40 mg and 50 mg.

The Food and Drug Administration (FDA) approved the updated formulation with BeadTek on Jan. 30. Zohydro ER with BeadTek delivers an extended release of hydrocodone that provides 12-hour dose duration, and the BeadTek technology encompasses an indistinguishable mix of inactive beads, active immediate-release hydrocodone beads and active extended-release hydrocodone beads.

When taken as directed, the inactive beads in Zohydro ER with BeadTek remain inert and dissolve independently of the active hydrocodone beads. The inactive beads do not change the 12-hour release properties of the medication, but when crushed and dissolved in liquids or solvents they immediately form a viscous gel.

“Zohydro ER is an ideal strategic fit for Pernix, having tremendous synergy with our existing CNS [central nervous system] franchise. It also represents a major step forward in our strategy to expand our commercial reach,” stated 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.”

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, according to Pernix. Zohydro ER does not contain acetaminophen, unlike many immediate-release hydrocodone products, reducing the risk for potential liver toxicity due to overexposure of acetaminophen, the company noted.

“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,” commented Srinivas Nalamachu, M.D., president and medical director of the International Clinical Research Institute in 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.”