U.S. Advisory Panel Restricts Use Of Hydrocarbon Based Pain Killers- ZGNX, ABT
Northern, WI 1/28/2013 (avauncer) - According to a government advisory panel, the most widely used hydrocodone painkillers should be restricted for use as they are being potentially abused.
The advisory committee has voted 19-10 for raising the bar on restrictions on hydrocodone-combination drugs such as Abbott Laboratories (NYSE:ABT) Vicodin and other cough suppressants which contain hydrocodone as an ingredient. In 2008, the FDA had struck down an appeal by the Drug Enforcement Administration for tighter control of this element and it waits to be seen whether it accepts the panel’s recommendation this time around.
The DEA is asking for 90-day supply prescriptions instead of the present 5 top-ups in 6 months. They are also asking that dentists, physician assistants and nurse practitioners should not be allowed to prescribe these pills. Statistics reveal that 131 million hydrocodone products were given out over the counter as compared to almost half the figure for oxycodone pills which are more tightly controlled.
According to Maria Suarez-Almazor, a professor at the Texas University, she was shocked to know that hydrocodone is the most dispensed drug in the US and she felt that there was something drastically wrong with the health-care system that has allowed it.
Hydrocodone as an ingredient in painkillers is a Schedule III controlled substance in a 5-stage scale whereas pure hydrocodone stands at Schedule II and hence is more restricted.
The proposal being sought today would elevate the position of hydrocodone combination drugs to Schedule II. The people who are not in favor of this schedule change said that there is a medical need of the people for opium-like drugs and also there could be a threat of illegitimate use if patients were not able to access painkillers freely.
The DEA and the FDA do not see eye-to-eye as the proposal of the DEA in 2004 had been struck down by the FDA in 2008. Then the DEA made the application yet again in 2009.
Joseph Rannazzisi of the DEA is of the opinion that the drug has a strangle-hold on society and the medical fraternity is averse to taking any serious action against this drug.
But Silvia Calderon of the FDA plays it down saying that the abuse factor of the drug is a relative mentality. She added that instead of changing the status of these drugs, there was a need to think about alternatives like educational awareness and prescription monitoring of the drugs. These alternatives may work in restricting potential abuse.
But there are many panelists and public speakers who doubt that the status change to Schedule II will ensure abuse of the drug is curtailed. An example cited by a Massachusetts Women’s Hospital, is that of Oxycotin which is a Class II drug but is the most abused.
Zohydro, which is Zogenix Inc., (NASDAQ:ZGNX)’s pure hydrocodone analgesic, did not gel well with the FDA officials who were of the opinion that the company had to do some more research on the drug to dissuade drug-abusers from crushing the tablets and inhaling them for euphoric highs.
The shares of Zogenix Inc., (NASDAQ:ZGNX) closed at $1.44. The shares of Abbott Laboratories (NYSE:ABT) were down 0.03% to $32.79.