The Food and Drug Administration has approved a new form of pain-reliever OxyContin designed to reduce tampering and abuse.

It is difficult to cut, crush, chew, or dissolve the new pills, preserving the slow release of the active ingredient, oxycodone, over time.  If a potential abuser tries to dissolve the pills in water, they form a gummy mass that cannot be injected.

After the new formulation is on the market, the FDA will require Purdue Pharma, the manufacturer of OxyContin, conduct a study of how well it meets the goal of reducing abuse and misuse.  Purdue also must develop a Risk Evaluation and Mitigation Strategy (REMS) that includes a medication guide for patients and education for health care providers on the appropriate use of opiates to manage pain.

OxyContin releases the an opiate pain medicine, oxycodone, slowly over time.  It is helpful to people with chronic pain, including cancer pain, who need round-the-clock pain relief.  Because of its timed release, each pill contains a large dose of oxycodone, making it risky for overdose or abuse.

In the older formulation, caregivers sometimes crushed the pills for patients who had trouble swallowing, resulting in accidental overdoses. OxyContin also has been widely diverted from medical use to drug abuse, where pills were crushed and inhaled or dissolved and injected, releasing a large amount of oxycodone to produce euphoria.

Abuse of OxyContin is high.  According to the 2008 National Survey on Drug Use and Health, half a million new people began misusing it for non-medical purposes.

The FDA warns that the new OxyContin formula does not completely eliminate the risk of overdose or abuse.  People can still take larger than recommended doses.  Health care professionals need to remind patients and their care partners not to exceed prescribed doses of the drug.

Bob Rappaport, MD, director of the Division of Anesthesia and Analgesia Products in the FDA’s Center for Drug Evaluation and Research, commented,

Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction. As with all opioids, safety is an important consideration. Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain.

Briefly: Randomized research found that radiation treatment to the entire brain after surgery for tumors that had spread to the brain didn’t improve either survival or the time that patients remained able to function independently.  Mice with muscle wasting and fat loss from cancer benefited from a commonly used diabetes drug.

In other headlines, Katie Couric received an award from Fordham University and called her work with colorectal cancer awareness “her greatest achievement.”  A panel at the FDA has recommended approval of a new formulation of OxyContin that is less easy to tamper with. Online registration for the October 4th Strides for Life Walk/Run closes on October 1.

Research Reports

• Whole brain radiotherapy (WBRT) after surgery or focused brain radiation to treat brain tumors that have spread into the brain from other cancer sites doesn’t improve either overall survival time or the time that patients are able to function independently.  It did extend time before cancer got worse within the brain and prevented some deaths directly caused by pressure within the brain compared to patients who were only observed after their initial surgery. R. Soffietti reported the results of a randomized study over more than 350 patients with brain metastases at the ECCO/ESMO Multidisciplinary Congress in Berlin.
• Mice with colon tumors treated with the diabetes drug rosiglitazone (Avandia®) gained weight despite having developed insulin resistance and initial weight loss.  Mice with cancer who didn’t receive the drug lost weight and fat tissue.  Scientist theorize that insulin resistance, which contributes to obesity and type 2 diabetes, actually is part of the muscle wasting and severe fat loss in cancer patients known as cancer cachexia.  Martha Belury from the Department of Human Nutrition at the Ohio State University says that is it too early to know if the drug would combat cachexia in humans.  Her team’s research is reported online in the International Journal of Cancer. More information about the study is available in an OSU press release.

Other Headlines

• CBS Evening News anchor Katie Couric says that her work to wipe out colorectal cancer has been her greatest accomplishment.  Accepting the Brien McMahon Award for Public Service at Fordham University, Couric recalls her desperate search for ” some kind of magic bullet that would make Jay well” during her husband Jay Monahan’s battle with colon cancer.  After Monahan’s death, Couric had a colonoscopy on morning TV to raise awareness of the test and colorectal cancer prevention.  She founded the National Colorectal Cancer Research Alliance and helped establish the Jay Monahan Center for Gastrointestinal Health in New York City.
• A joint meeting of Food and Drug Administration (FDA) pain and medication safety panels  on September 24, 2009 recommended approval of a new formulation of the opiate painkiller OxyContin which is designed to make it harder to abuse.  Currently OxyContin can be crushed into power which abusers can snort, smoke, or dissolve in water and inject providing a powerful, heroin-like effect.  The new pills are coated with resin which makes them very difficult to crush.  Dissolved in water, they form a gel.  If approved by the FDA, Purdue Pharma, manufacturers of OxyContin, will no longer ship the older product but begin distributing the tamper-proof medication, marketing it as a “safer” version.  An article , September 24, 2009. about the FDA panel decision written by Emily Walker  was published on MedPage Today.
• Online registration for the annual Strides for Life/Get Your Rear in Gear Walk/Run closes on October 1, 2009.  Strides for Life honors the memory of Dylan Cappel, who died of colon cancer at the age of 23 while training for a spot on the US Olympic rowing team.  The Walk and Run will be held on October 4th at Lake Merced in San Francisco, sponsored by the Strides for Life Foundation.