San Diego-based drugmaker Zogenix's resolution for 2012: get the FDA to approve Zohydro, the first pill of pure hydrocodone.
The experimental pain drug, purported to be ten times more powerful than Vicodin, is designed to release its payload of hydrocodone over an extended time. Creative addicts, however, will surely devise ways to circumvent this technology and get a whole lot higher a whole lot faster.
Because the drug is not cut with acetaminophen or other nonaddictive substances, the laws require that patients visit their doctors every time a refill is in order. Although this may curb the likelihood of abuse, some basic number-crunching by Jeffrey Kluger over at Time raises a few red flags:
"It's true too that the new überhydrocodone will require patients to appear at a doctor's office in person each time they want a prescription refilled -- as opposed to simply getting a single prescription with five refills built in, as is sometimes the case with current hydrocodone-based meds. But you're talking about 30 days of hydrocodone pills formulated at 10 times the current dosage. That -- and feel free to check my math here -- is the milligram equivalent of 300 days of the stuff. Might this be a problem?"
It's unclear how the growing scrutiny of pain pills will affect Zogenix's chances of getting the drug approved.
There has been an outcry among addiction experts that such a strong formulation of an already abused drug will lead to an uptick of health issues, overdoses, and associated crimes -- problems South Florida is all too familiar with. Drug Enforcement Agency data show that hydrocodone killed 910 Floridians between 2003 and 2007 and was associated with nearly 2,000 additional deaths in the state.
One potential benefit of a pure hydrocodone pill is that it would eliminate the side effects -- mainly liver failure -- associated with drugs that mix in acetaminophen.
Zogenix said in a December news release that it plans to submit a formal application for the drug in the second quarter of 2012. If the pill passes regulatory muster, pharmacies could start filling scripts come 2013.