FDA panel opposes pure hydrocodone painkiller

WASHINGTON (AP) — Government health experts overwhelmingly voted against a stronger version of hydrocodone on Friday, questioning the need for a new form of one of most widely abused prescription painkillers.

The Food and Drug Administration's panel of pain specialists voted 11-2 with one abstention against Zohydro for moderate to severe chronic pain. The drug was developed as a long-acting pain reliever by San Diego-based Zogenix Inc.

The FDA is not required to follow the group's recommendation, though it often does so.

The panelists acknowledged that the pill would likely reduce pain, but worried it would exacerbate the national epidemic of prescription painkiller abuse.

"I think the sponsor fulfilled the expectations of FDA, however I think the entire class is problematic in terms of abuse and safety issues," said professor James Ware of the Harvard School of Public Health.

If approved, Zohydro would be the first pure hydrocodone medication available in the U.S. Currently available products combine the drug with lower-grade painkillers such as acetaminophen.

Hydrocodone is prescribed to treat pain from injuries, surgery, arthritis, migraines and a variety of other ailments.

Hydrocodone-containing pills consistently rank as the first or second most-abused medicines in the U.S., according to the Drug Enforcement Administration.

The drug belongs to a family of medicines known as opiates or opioids because they are chemically similar to opium. They include morphine, heroin, oxycodone, codeine, methadone and hydromorphone.

Opiates block pain but also unleash intense feelings of well-being and can create physical dependence. Several panelists said the risks of fatal overdose with opioids swayed their vote against Zohydro.

"I have traveled around the country and I have seen the repercussions of opioids — they are a threat to public health," said consumer panelist, Rodney Mullins, of the Health Promotion and Advisory Council.

In 2011, the Centers for Disease Control estimated 14,800 deaths were related to opioids.

Zogenix has touted the benefits of its long-lasting pill, which only needs to be taken once every 12 hours, compared with every four to six hours for combination drugs like Vicodin. The company also notes that patients taking pure hydrocodone would not be at risk for acetaminophen-related liver side effects.

Panel Chairman Randall Flick of the Mayo Clinic abstained from voting, but suggested Zogenix might reformulate the drug to make it more difficult to abuse. Drug abusers often crush or dissolve pills in liquid to unlock their extended release mechanism and get an intense high.

"It is my view that tamper-resistant formulations are likely to reduce the incidence of morbidity and mortality associated with this class of drugs," Flick said.

In recent years the FDA has begun prodding drugmakers to develop more sophisticated pain relievers that are harder to abuse, but such measures are not a requirement.

Zogenix said it would focus sales on 15% of the 330,000 U.S. health professionals who prescribe high-strength prescription painkillers. The company said it would to monitor prescribing patterns and visit physicians who appear to be writing more prescriptions than normal.

Shares of San Diego-based Zogenix were halted ahead of the meeting and last traded at $2.36.

New Bath Salts Research Available to Coalitions

The National Institute on Drug Abuse, part of the National Institutes of Health, has released electronically-published research on “bath salts” applicable to coalition work.

“DrugFacts: Synthetic Cathinones (“Bath Salts”) details new research on what this emerging category of drugs does to the brain. The term “bath salts” refers to an emerging and dangerous family of drugs containing one or more synthetic chemicals related to cathinone, an amphetamine-like stimulant found naturally in the Khat plant. 

Dr. Michael Baumann, NIDA staff scientist and researcher, said the DrugFacts publication is part of the ongoing designer drug initiative with various federal partners including the Drug Enforcement Administration. 

To avoid confusion when describing the drug in coalition educational campaigns and advocacy work, Dr. Baumann recommends calling the drugs Synthetic Cathinones, also referred to as ‘bath salts,’ since the drugs are not pleasantly-scented bubble bath. 

Sold under such names as Ivory Wave, Red Dove, Bliss and Vanilla Sky, or referred to as innocuous, everyday items like ‘plant food,’ synthetic cathinones contain chemicals that can cause amphetamine like reactions such as hallucinations, paranoia, rapid and irregular heartbeats and suicidal thoughts. All of these names and seemingly infinite chemical alterations by mostly overseas synthetic chemists are to skirt regulatory control, they are not really something that one would want to put in their body, Dr. Baumann said. 

“As we continue to with the DEA, our piece is to determine the risk, pharmacology and toxicology. We know that these are synthetic stimulants, so we have been studying what are the drugs out there? What are these drugs actually doing? What’s the toxicology?” he said.

Dr. Baumann also notes that very little is known about how these substances interact with other drugs and alcohol.

“In the lab, we’re only beginning to unravel what these drugs are doing to the brain and the body,” he said. CADCA’s members have worked at the local, state and federal levels on policies that have identified retailers and contributed to banning the drugs’ use. Many contributed their recommendations to amend the Controlled Substances Act and designate certain synthetic substances as schedule I drugs. ‘Bath salts’ and a number of synthetic marijuana compounds will now be banned across the country. Internet sales have been problematic, however.

“There are individuals who actually document their trips online for others to learn from,” Dr. Baumann said. 

The 2012 Monitoring the Future survey on nation-wide teen drug use will include bath salts for the first time. Survey results will be released Dec. 19.