Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

ADF Wars: Zohydro with BeadTek™

http://www.pernixtx.com/news/pernix-launches-zohydro-er-with-beadtek/

About BeadTek™
BeadTek technology was developed using safe, well-known excipients and proprietary manufacturing processes to create an inactive ingredient that immediately forms a viscous gel when crushed and dissolved in liquids or solvents. All of the beads within the medication capsule are indistinguishable in color, shape, density and size, and do not impact the drug release profile when taken as directed.

Sound familiar? A capsule of beads indistinguishable by color, shape, size, and density. Hmmm. Where have I heard that before?

As far as I am aware, neither Zogenix or Pernix (current owner) have ever released any HAL data for Zohydro with BeadTek, not even top line results. Not even to say the results were "statistically significant." (I'm looking at you, Egalet.)



http://www.zohydroer.com/downloads/ZOHYDROERFullPrescribingInformation.pdf

ZOHYDRO ER must be taken whole [see Patient Counseling Information (17)]. Crushing, chewing, or dissolving the beads in ZOHYDRO ER capsules will result in uncontrolled delivery of hydrocodone and can lead to overdose or death [see Warnings and Precautions (5.1)].

Taking cut, broken, chewed, crushed, or dissolved ZOHYDRO ER enhances drug release and increases the risk of overdose and death. 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.

Elite's 2 bead pharm-based ADF is universal and can be used with any opioid agonist and any time-release characteristic. It cannot be chewed, crushed, snorted, or injected. Period.