SEC Filings

8-K
PERNIX THERAPEUTICS HOLDINGS, INC. filed this Form 8-K on 02/19/2019
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17 Chronic Pain Market Product Summary • Extended Release (ER) oral formulation of hydrocodone bitartrate designed with abuse - deterrent technology • The currently marketed formulation was approved in 2015 under Zogenix and then subsequently acquired by Pernix who initiated the commercial launch in May of 2015 • Zohydro ® ER provides true 12 - hour dosing for more consistent pain relief (1) • BeadTek technology allows for an indistinguishable mix of Immediate Release (IR) and Controlled Release (CR) hydrocodone beads, plus inert beads designed to provide abuse - deterrent properties • Inert beads form a viscous gel when crushed and dissolved in liquids or solvents • Chronic pain is defined as pain that lasts longer than three months • More than 100M Americans suffer from chronic pain • Opioids are the primary class of drug prescribed by physicians for moderate - to - severe chronic pain • Hydrocodone is often used to initiate opioid therapy • 85M IR hydrocodone TRx , approximately 30% of which are used in patients with chronic pain • ER products are physician preferred therapeutic alternatives compared to IR hydrocodone products • ER products allow for once to twice daily dosing compared to multiple dosing required by IR formulations • Many IR hydrocodone products contain acetaminophen, which has been shown to significantly increase the risk of liver or gastrointestinal damage if used over extended periods of time • Zohydro ® ER with BeadTek ® technology provides extended release relief to treat chronic pain and includes abuse deterrent technology • Zohydro ® ER provides true 12 - hour dosing for more consistent pain relief; indistinguishable mix of IR and CR hydrocodone beads provide fast acting and sustained pain relief (1) Nalamachu S et al. Pain Medicine 2015; 16: 2338 - 2343 Zohydro ® ER with BeadTek ® Overview