Zogenix Ditches Its Controversial Drug Zohydro

On March 10, 2015 Zogenix announced an agreement to sell Zohydro ER (hydrocodone bitartrate) to Pernix Therapeutics. As part of the agreement, Zogenix will pay Pernix $100 million up front ($30 million in cash, $20 million in common stock, and $50 million in short term promissory note) with the potential for regulatory and sales milestones up to $283.5 million.

The agreement will allow Zogenix to shift its focus to late-stage central nervous system clinical pipeline featuring two potential Phase III drugs: ZX008, which has orphan drug designation in the US and EU and is for the treatment of Dravet syndrome; and Relday, a long-acting injectable risperidone formulation for the management of schizophrenia.

A writer for TheNew York Times blog reported in April 2014 on the 2013 controversy when FDA approved Zohydro, causing state legislatures to try and ban the drug outright because of its hydrocodone’s addictive qualities. There was so much controversy surrounding the drug that Zogenix released a page on its website, Let’s Get the Facts Straight about Zohydro ER Extended Release Capsules. The page sets out to debunk myths about the drug and reassure patients that the drug is the same potency as other opioids on the market, and the highest dose is significantly lower than the highest dose of oxycodone or morphine. The company defended its drug in 2014 by stating “Zohydro ER deserves to be judged on its medical merits and the benefits it provides to patients suffering from chronic pain, not on the basis of media reports. Over the coming weeks, we will continue to report and distribute accurate information to address common misperceptions about Zohydro ER”.

Source: Zogenix