Zogenix progresses on abuse deterrent versions of Zohydro


Zogenix (ZGNX) plans to submit an sNDA by October 2014 for a next-generation version of Zohydro (hydrocodone bitartrate) Extended-Release Capsules that incorporates unspecified abuse deterrent technology designed to make it more difficult to abuse via injection or snorting. If approved, the new formulation will be available in early 2015.

The company has also selected the final tablet formulation for clinical development in its collaboration with Altus Formulation. The product will incorporate abuse deterrent technology that maintains the extended-release properties of Zohydro when the tablet is crushed or chewed. This minimizes one on the ways that opioids are abused. It will have additional features that addresses abuse by injection or nasal administration.  Zogenix plans to submit an NDA in H1 2016.

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Comments (2)
  • nlrreddy
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    after so many days, some very good news
    2 Jul 2014, 09:33 AM Reply Like
  • johnRX Doc
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    The pain control market has had a need for Acetaminophen(APAP) free formulations of Hydroocodone for years. Unfortunitately, many patients have suffered severe liver damage and even death due to liver failure from high dose APAP because of the need to increase doses of the hydrocodone + APAP drugs that heretofore have been the only source of a hydrocodone containing pain control drug.( exception , there is a hydrocodone + ibuprofen drug combination available that has been on the market for years but is a small portion of the annual sales of hydrocodone containing products) Additionally, we clinicians often have the need to treat chronic pain patients with a "long acting narcotic analgesic " for baseline control of pain and then use short acting preps for breakthrough pain episodes. In the past we have had to put patients on a second narcotic analgesic ( long acting) such as methadone or OxyContin ER to cover baseline pain and then used short acting hydrocodone/APAP doses for breakthrough pain. This has not been ideal as many pain clinicians prefer hydrocodone to other narcotic analgesics because of it tends to cause less drowsiness and nausea. Zohydro for many clinicians brings a significant advantage to patient treatment by allowing the patient to remain on a single narcotic analgesic for both baseline and breakthrough pain control. BUT because of the abuse potential of the current Zohydro preparation (crush,snort,inject) I believe many have hesitated to use it. Many have been waiting for the abuse deterrent technology to be incorporated into the drugs formulation.(it was a game changer for OxyContin ER). I believe the current preparation on the market will continue to grow in use, but when the re formulated product becomes available, sales should increase significantly. I remain long ZGNX and will increase my position on this news.
    2 Jul 2014, 10:19 AM Reply Like
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