revenues and income 2013, page-78

The rejection of Zohydro by the FDA has come after strong lobbying by government and community representatives to stop approval of the drug, something which we already discussed early this year.

Numerous state senators had written to the FDA urging “extreme caution” in its decision making because they feared Zohydro’s potential for abuse. Opponents had noted that the number of hydrocodone-related emergency room visits increased from 19,221 in 2000 to 86,258 in 2009 nationally. The senators suggested that the FDA require that any new hydrocodone-based painkiller be manufactured in a tamper-resistant form.

One reason for the high level of abuse of hydrocodone is a 41-year-old loophole in the federal Controlled Substances Act, which puts fewer controls on combination pills containing hydrocodone and another painkiller than it does on the equivalent oxycodone products. Consequently, prescriptions for the hydrocodone combination drugs can be refilled five times, whereas an oxycodone prescription can only be filled once.

Zogenix was counting on the Schedule II (ie. stricter controls) classification that its pure hydrocodone drug would attract as its only safety feature, choosing not to create a tamper-resistant formulation for Zohydro to prevent abusers from snorting or injecting. Company officials said they were working on a tamper resistant version, but it was a “few years” away.

The FDA obviously didn’t buy that argument and rejected Zohydro because of concerns regarding addiction and abuse. “If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products,” FDA staff reviewers wrote.

I suspect that this FDA rejection is a warning shot to drug companies seeking future approval of opioid products – no tamper-resistant features, no approval. The only surprise here imo is that Zogenix thought it could get away with it.


http://topnews.us/content/252100-zohydro-er-faces-fda-rejection

http://americannewsreport.com/fda-panel-rejects-new-painkiller-zohydro-8817002

http://www.wickedlocal.com/danvers/news/x740682905/Senators-urge-FDA-to-reject-new-pure-painkiller-without-safeguards#axzz2EcCP6tGo

http://healthland.time.com/2011/12/26/powerful-new-painkiller-has-addiction-experts-worried/#ixzz1jV5mQRkn