History of OxyContin
OxyContin has consistently been approved around the world. It is the long-lasting version of the commonly prescribed medication oxycodone. Media reports often incorrectly refer to OxyContin (which actually accounts for a tiny fraction of the prescription opioid market) when, to be accurate, they should refer to oxycodone instead.
2020 Letter to U.S. Senate: FDA Director of Center for Drug Evaluation & Research (now FDA Acting Commissioner) Janet Woodcock Stands by Approval of OxyContin Since 1995
In the United States, the Food and Drug Administration has sole responsibility and authority for approving prescription (Rx) medications. OxyContin has been re-reviewed multiple times since its approval in 1995. That approval process has also been repeatedly scrutinized and validated.
“FDA has examined the original 1995 approval of OxyContin, the approvals of the supplemental applications for the 80-mg and 160-mg strengths, and the approval of the 2001 safety labeling change. All applicable statutes and regulations were followed.”
“Approval was based on efficacy findings from six controlled studies.”
“… when OxyContin was approved in 1995 it was not limited to the treatment of acute pain or otherwise limited in its duration of use. Chronic or long-term use (in appropriate situations), with no maximum duration, was always part of the approved use of OxyContin.”
“The disturbing reality that there are individuals who will intentionally prescribe and dispense opioids inappropriately for financial gain underscores the complex factors that contribute to the opioid crisis.”
“OxyContin is not appropriate for ‘as-needed dosing’ (PRN), or in the immediate post-operative period if pain is mild or not expected to persist for an extended period of time.”
“FDA also recently funded a research project to study the effect of opioid analgesic deprescribing (i.e., tapering and/or discontinuing) on patient outcomes, including suicidality, completed suicide, and overdose…”
DR. JANET WOODCOCK LETTER, 2020[1]
Estimated Number of Prescriptions Dispensed for Opioid Analgesics vs. Oxycodone Extended-Release from U.S. Outpatient Pharmacies[1]
OxyContin Introduced as First Extended-Release Form of oxycodone
OxyContin presented an attractive option to doctors treating moderate/severe chronic pain:
- Extended Release: Less frequent dosing meant fewer “dosage cups,” less sleep disturbance.
- oxycodone: Approved as short-acting medication in 1916.
Competitive Landscape of Extended-Release Opioids
OxyContin: Just One of Many Prescription Opioids Doctors Prescribe for Treating Patients
All opioid medicines have always been known to carry risk of addiction and abuse, which is why they are Schedule II medications. As early as the 1910s, states implemented prescription monitoring programs when prescribing Schedule II drugs because of known risk of abuse.[2]
Prescription Opioid Overview
OxyContin: One Part in Long History of Prescription Opioids
“OxyContin” or “Oxy” Often Misleadingly Used as Shorthand for oxycodone & for Prescription Opioids Generally
| oxycodone | OxyContin | |
|---|---|---|
| Description | generic chemical compound | extended-release oxycodone |
| Clinical use began | 1917 | 1996 |
| Sold as | oxycodone, Percocet, Percodan, Xtampza ER, Roxicodone, Oxaydo, Tylox, Oxycet, OxyContin, etc. | OxyContin |
| Duration | ranges from approximately 4 hour immediate-release formulas to 12 hour extended-release formulas | approved by FDA for 12 hours |
| Active ingredient | oxycodone | oxycodone |
Original language
Oxycodone, a powerful opioid marketed as OxyContin, was approved in 1995 for pain relief…
Corrected language
Oxycontin, a controlled-release form of the powerful opioid oxycodone, was approved in 1995 for pain relief…
Original headline
Bachelor in Paradise star Jackson Garlick comes under fire for sharing a snap of OxyContin pills and alcohol with the caption ‘name a better duo’.
Corrected headline
Bachelor in Paradise star Jackson Garlick comes under fire for sharing a snap of oxycodone pills and alcohol with the caption ‘name a better duo’.
Original
The Apple TV description for the film “Crisis” erroneously mentioned “OxyContin,” but the movie only ever said “oxycodone” or “oxy.” (The description has since been updated to say “oxycodone.”)
Original
The Netflix film “Extraction” uses an OxyContin bottle to depict drug use, but the movie never says what medicine is being abused.
National Media Coverage of OxyContin Misuse Emerged in Late 2000 & 2001, Following News Reports About Other Opioid Medications
Drug Use Weakened Allegations of Abuse
“Vicodin is abused a lot,” said Robert Popovian, a doctor of pharmacy and a researcher at USC.
SEPTEMBER 10, 1995[7]
“It’s a problem.”
Vicodin, My Vicodin
“It is the painkiller of choice for thousands of drug users, legal and illegal both.”
JANUARY 1, 1999[8]
Misuse of Pain Drug Linked to Hearing Loss
“Vicodin, one of the most commonly prescribed painkillers, is frequently used improperly.”
SEPTEMBER 10, 2001[9]
Some of This Media Coverage Included Specific Directions on How to Use OxyContin Improperly for Recreational Purposes
The Potent Perils of a Miracle Drug
“In any given week, her husband reportedly told investigators, the couple supplemented their Social Security by selling drug addicts $8,000 worth of the tiny white tablets that are chewed or smashed to remove the time-release coating, then snorted or injected, generating a high as intoxicating as that of heroin.”
TIMOTHY ROCHE
DECEMBER 31, 2000[10]
The Alchemy of OxyContin
“But these days, she says, the only drug for sale in Man is OxyContin, a narcotic painkiller that users crush — to disable its patented time-release mechanism — and then snort or inject for a powerful and immediate opiate high. Legally, it’s sold only by prescription for the treatment of chronic pain. In practice it’s available just about everywhere around here, immediately, for cash. The going rate is a dollar a milligram, or $40 for a 40-milligram pill.”
PAUL TOUGH
JULY 29, 2001[11]