FDA approves tamper-resistant reformulation of Zohydro in continuing battle against opioid abuse

FDA

The FDA approved a reformulated version of Zogenix's ($ZGNX) painkilling Zohydro ER designed to be abuse resistant, marking another step in the battle against opioid abuse and another chapter in a long-running battle over the controversial and potentially addictive medication, in which some have gone as far as to call for FDA Commissioner Margaret Hamburg's resignation over the 2013 approval of the conventional formulation.

However, more data are needed for the medication to receive an abuse-deterring label, something few drugs have, with the exception of Purdue Pharma's competing painkiller Hysingla. It launched last week and has the advantage of labeling that already sports its abuse-deterrent features.

The newly approved version of the Zohydro ER extended-release opioid agonist uses Zogenix's BeadTek formulation designed to make it harder to abuse the medication by crushing and snorting it. "BeadTek incorporates well-known pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents," Zogenix said in the approval release.

The company aims to transition to the new formulation in the second quarter of this year and submit data for an amended label with abuse-deterrent claims in the second half of the year, according to the release.

The long-awaited announcement sent Zogenix stock up almost 9% over the weekend, but it is still a penny stock. The approximately $1.40 share price reflects the small cap's unprofitably meager revenues of $8.8 million and dearth of other approved products besides Zohydro ER.

In its Q3 2014 SEC filing, the company said it ended the quarter with $7.9 million in deferred revenue from the medication. The company sells Zohydro to wholesalers and defers booking revenue until the customers' right of return expires or the drug is prescribed to patients.

"The new formulation has identical hydrocodone-release characteristics compared to the Zohydro product approved today, when it's used as intended, but has been designed to make it difficult to manipulate the purpose of abuse by injection or nasal insufflation or snorting," Zogenix President Stephen Farr told investors during the Q3 earning call, which was held prior to the formulation's recent approval.

But more efforts to make the drug abuse resistant are still ongoing under a partnership struck with a Canadian drug formulation and development company in 2013. "We are continuing to make great progress in the development of an abuse-deterrent tablet formulation of extended-release hydrocodone under our collaboration with Altus Formulation," Farr said. "As we previously communicated, a new drug application submission is being targeted for the first half of 2016, which will reference the approved Zohydro NDA with respect to previous findings of safety and efficacy."

Pharmacy benefit manager Express Scripts dropped Zohydro from its formulary as of the beginning of the year, but Zogenix CEO Roger Hawley said during the Q3 conference call that "we do hope to revisit that once we have (an) abuse-deterrent formulation of Zohydro," so keep an eye on that issue now that the approval has occurred.

Zohydro ER has been the subject of intense controversy that is not in proportion to the drug's moderate sales but reflects the scale of the prescription drug abuse epidemic. Zogenix responded with an aggressive PR campaign in defense of the medication and now hopes the new formulation will quiet the critics.

- read the release

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