Zogenix, manufacturer of controversial hydrocodone pill Zohydro ER, announced yesterday that it would take several steps to retool the drug’s marketing campaign. The first order of business is to find a partner to raise the pain pill’s visibility among primary care physicians. The steps were revealed in the firm’s Q2 earnings call.
Leerink Swann analyst Jason Gerberry wrote in an investor note this morning that Zogenix management is “looking at copromote partnerships to start in 2015,” as well as refocusing the sales team “in territories with the highest growth potential…to ensure they are deploying resources appropriately.”
Zogenix management called out the New England area—specifically Massachusetts—as slow to adopt its pain pill, and given that Massachusetts governor Deval Patrick has tried to ban the pill outright—it makes sense that the drugmaker has decided to reexamine its sales and marketing investment in the region.
The drugmaker also reaffirmed plans for two abuse-deterrent formulations by the first half of 2015 and 2016. It may be too little too late. Purdue Pharma’s own once-daily, abuse-deterrent hydrocodone tablet received priority review status last month, and the FDA has pledged to decide on the drug by October 2014.
If Purdue succeeds in getting its hydrodocone bitartrate treatment, which has anti-abuse properties, on the market first, Zohydro could be dead in the water. That’s a possibility hinted at by FDA director of pain drugs Bob Rappaport, who stated, “If and when [Purdue], or another manufacturer, are able to create an abuse-deterrent formulation that remains safe and effective for patients, we would certainly give serious consideration to assuring that any [non-abuse-deterrent] formulations are removed from the market.”
Since its launch, Zohydro has come under fierce scrutiny. West Virginia Senator Joe Manchin sponsored the “Act to Ban Zohydro Bill,” and 28 US attorney generals beseeched FDA commission Margaret Hamburg to reverse the drug’s approval, saying the drug “has the potential to exacerbate our nation’s prescription drug abuse.”
Ire stems from the fact that Zohydro was approved without an abuse-deterrent formulation, leaving the drug open to intravenous drug use and insufflation (snorting), even as the CDC has classified prescription drug abuse as an epidemic.