Shares of biopharmaceutical company Zogenix, Inc. (ZGNX) are up 16% in trading on Wednesday after the company announced that a new, abuse-deterrent formulation of Zohydro ER, its extended-release hydrocodone product, could be on the market by early 2015. Zohydro was approved in 2013 to the chagrin of many providers and legislators given the narcotic’s lack of abuse-deterrent qualities. The stock climbed expeditiously following the approval but has suffered this year as criticism of Zohydro’s abuse-ability has escalated, and investors have speculated that Zohydro could even be pulled from the market.
This is the first defined guidance from Zogenix on this new abuse-deterrent version of Zohydro. The company said that following a recent meeting with the FDA, it now expects to file a supplemental New Drug Application, which would rely on the approved formulation of Zohydro for reference, by October 2014. According o the company, the new capsule formulation will “make it more difficult to abuse by injection or nasal administration.”
Investors are rewarding the stock because a new abuse deterrent formulation would put to rest concerns that Zogenix’s primary product is at risk of being pulled from the market.
Zogenix also announced the selection of a tablet formulation in collaboration with Altus Formulation. The company expects a NDA submission during the first half of 2016. This is in-line with previous guidance for a “longterm” solution to Zohydro’s lack of abuse-deterrents by 2016; Wednesday’s guidance for the “short-term” solution by early 2015 is new, hence the market’s positive reaction.
You can read about Zohydro ER and Zogenix in PropThink’s previous coverage.
Two other names worth knowing for their involvement in the immense painkiller market: Durect Corp (DRRX) and Pain Therapeutics (PTIE), which developed Remoxy (extended release oxycodone) before Pfizer (PFE) acquired the asset in 2011. Read more.
