According to recent news, pharmaceutical companies are approaching the final stages of development for a new type of painkiller, and it is causing some concern for many. The said painkiller is supposedly 10 times stronger than Vicodin, and addiction experts worry that abuse of the drug may become a terrible problem.
Four companies have already begun patient testing on the pills which contain a pure version of the highly addictive painkiller hydrocodone, and one of them – Zogenix of San Diego – plans to apply early next year to begin marketing its product, Zohydro.
If approved, it would mark the first time patients could legally buy pure hydrocodone. Existing products combine the drug with nonaddictive painkillers such as acetaminophen.
Hydrocodone belongs to family of drugs known as opiates or opioids because they are chemically similar to opium. They include morphine, heroin, oxycodone, codeine, and methadone.
Critics are especially worried about Zohydro, a timed-release drug meant for managing moderate to severe pain, because abusers could crush it for an intense, immediate high.
“I have a big concern that this could be the next OxyContin,” said April Rovero, president of the National Coalition Against Prescription Drug Abuse. “We just don’t need this on the market.”
Pure hydrocodone pills would avoid liver problems linked to high doses of acetaminophen, an ingredient in products like Vicodin, according to the drug companies. They also say patients will be more closely supervised because they will have to return to their doctors each time they need more pills. Prescriptions for the weaker, hydrocodone-acetaminophen products can be refilled up to five times.
Zogenix has already completed three rounds of patient testing, and last week it announced it had held a final meeting with FDA officials to talk about its upcoming drug application. It plans to file the application in early 2012 and have Zohydro on the market by early 2013.
Purdue Pharma and Cephalon, a Frazer, Pa.-based unit of Israel-based Teva Pharmaceuticals, are conducting late-stage trials of their own hydrocodone drugs, according to documents filed with federal regulators. In May, Purdue Pharma received a patent applying extended-release technology to hydrocodone.
Egalet has finished the most preliminary stages of safety testing and could have a product on the market as early as 2015 but wants to see how the other companies fare with the FDA before deciding whether to move forward, Lindhardt said.
Critics are troubled because a new narcotic painkiller can lead to windstorm of problems; such as more murders, pharmacy robberies, and millions of dollars lost by hospitals to treat overdose victims. Thousands of legitimate pain patients are becoming addicted to powerful prescription painkillers, they say, in addition to the thousands more who abuse them illegally.
And, the problem just seems to be mounting. According to the CDC prescription painkillers caused 15,000 U.S. deaths in 2008, more than triple the 4,000 deaths in 1999. Emergency room visits related to hydrocodone abuse have shot from 19,221 in 2000 to 86,258 in 2009, according to the Drug Enforcement Agency. In Florida alone, hydrocodone caused 910 deaths and contributed to 1,803 others between 2003 and 2007.
With statistics like these, it is no wonder that experts are concerned!!