The Battle For Remoxy

Pain management pharmaceutical giant King Pharmaceuticals and its partner Pain Therapeutics have been pressing the U.S. Food and Drug Administration for a new label for a potentially lucrative pain drug, Remoxy.  The company is requesting a special labeling for the drug known as an abuse-deterrent label.  This label marks the drug as a safer alternative to a chemical that has been widely abused in the past, oxycodone.  Remoxy is a version of oxycodone, the active chemical compound in several popular pain management medications including Percocet and Oxycontin.  However, Remoxy comes in a time-release gel capsule that cannot be crushed or chewed and does not dissolve in liquid.  Thus, the company believes the drug has less potential to be abused.

In response to the request to include the abuse-deterrent label for Remoxy, the FDA said while it would not require further clinical trials for the medication, additional non-clinical data would be necessary.  King Pharmaceuticals will have to show that the drug warrants the abuse-deterrent label through presentation of data, including in-depth studies of patients using Remoxy for pain management and surveys of patients during treatment.

The abuse-deterrent label would be a lucrative branding for the company's medication.  Medications containing oxycodone have been statistically shown to be highly addictive, having severe withdrawl symptoms, and high abuse rates.  Across the globe, medications containing oxycodone are subject to the most stringent of drug control laws. 

A History of OxyContin Abuse

One particular medication that has a long history of abuse over the past decade is OxyContin, an extended release formulation of oxycodone.  Since OxyContin is an extended release, it contains mainly oxycodone as opposed to other name brand pharmaceuticals which contain oxycodone with other medications.  OxyContin can be crushed to defeat the time-release mechanism, and the powder can be ingested in a number of different ways.  The majority of OxyContin related deaths occur from overconsumption in combination with other depressants, such as alcohol and barbituates. 

Critics of the drug have accused the drug's manufacturer of pushing the medication onto doctors and hospital administrators, claiming its efficacy was superior to that of other opiods, including morphine.  In fact, executives from Purdue Pharmaceutical, the patent holder for OxyContin, plead guilty to felony charges that they misbranded the drug and misled physicians.  They claimed the drug was less likely to be abused, was less addicitve and less likely to cause withdrawl symptoms over other opiates. 

Congressional hearings were held in December 2001 and again in February 2002 to address the abuse of Oxycontin. Both the FDA and Purdue Pharmaceutical began to take steps to address the problems associated with the use and abuse of Oxycontin. In July 2001 the FDA strengthened the warnings and precautions section in the labeling, issuing a "black box" warning, the highest possible warning level. Together with Purdue Pharmaceuticals, the FDA also developed a risk management program to help detect the abuse of, and prevent abuse of, Oxycontin.

Quality Legal Adivce

The potential for abuse of OxyContin is high.  Despite the best efforts of law makers and law enforcement officers, many people obtain the drug for illicit use.  As a result, numerous deaths have been reported from improper usage, and many more incidents of irreparable damage to a person's body have been documented.  If you or someone you care about has been injured because of OxyContin usage, it is in your best interest to contact an experienced OxyContin attorney about a potential OxyContin lawsuit.