September 24, 2017  Last Update: December 21, 2016, 11:10 pm

Purdue Pharma Tests OxyContin on Children

Purdue Pharma tests Oxycontin on children, and some point out it looks more like a patent expiration avoidance maneuver than health-based clinical testing.

Purdue Pharma has sponsored two clinical studies that are actively recruiting children for tests of Oxycontin, its blockbuster pain-killer. Some critics of Purdue are suggesting these studies are more for commercial gain than safety or efficacy. Purdue’s primary patent for Oxycontin (hydrocodone HCL) expires in April of 2013.  Studies on children could support new claims for use of Oxycontin, potentially extending the patent protection 6 months or more.

The two studies are listed as:

“Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids”

“Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001”

A report in TheDaily.com cites Physicians for Responsible Opioid Prescribing (PROP). They suggest that the addiction potential for Oxycontin in children must be carefully evaluated, and that pediatricians have “given too much credence to drugmakers, who have systematically downplayed the dangers”.

In 2007 Purdue Frederick was convicted of felony mislabeling of ocycontin, according to Reuters reporting.  The company paid a massive fine for misrepresenting the addiction potential for Oxycontin among other charges. Three executives also pleaded guilty for misdemeanor versions of the same charges.

The PROP group advocates for safe prescribing, and doesn’t trust Purdue. It publishes a mission statement on its web site:

“Our mission is to reduce morbidity and mortality resulting from prescribing of opioids and to promote cautious, safe and responsible opioid prescribing practices.”

Web site Pharmalot also reported on the clinical trials for Oxycontin on children, and posted a response from Purdue:

"The focus of our studies is on children who are at least 6 years and less than 17 years of age who have moderate to severe pain, around the clock, who are already being treated with opioid medicines. These children have diseases such as cancer or sickle-cell anemia, post-operative pain, injuries such as severe burns causing this degree of pain. Currently, there is only a limited amount of data available on the use of oxycodone in pediatric patients. Physicians treating children with pain must rely on their clinical judgment and data from adult clinical trials. That is why studies to characterize the medication’s pharmacokinetics and safety in pediatric patients are needed."

On TheDaily.com,   Dr. Elliot Krane, of Lucile Packard Children’s Hospital at Stanford University in Palo Alto, California, is quoted to say “We are possibly opening the door to (OxyContin) being abused by a younger, more vulnerable population”.

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Oxycontin being tested on children: "We are possibly opening the door to (OxyContin) being abused by a younger, more vulnerable population".
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Resources:

  • Clinical Trial NCT01192295: Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
  • Clinical Trial NCT01369615: Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
  • TheDaily.com story
  • 2007: Purdue Frederick pleads guilty, pays $600 million dollar fines
  • 2007: Purdue pays $19 million to settle lawsuit from 26 states
  • Economic Times report on Purdue oxycontin patents
  • Physicians for Responsible Opioid Prescribing (PROP)

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