Opioid Epidemic

Events

Label Change

2001

OxyContin label was changed to add and strengthen warnings about the drug’s potential for misuse and abuse.

Warning letter

2003

FDA issued a Warning Letter to OxyContin’s manufacturer for misleading advertisements.

Safety Measures

2007

FDA Amendments Act granted FDA authority to require for certain drugs specified safety measures known as Risk Evaluation and Mitigation Strategies (REMS).

Drug Enforcement

2009

FDA held several public and stakeholder meetings, including May 27-28 public meeting
and December 4 stakeholder meeting, to discuss opioid risks, misuse, and abuse.
FDA partnered with U.S. Substance Abuse and Mental Health Services Administration
(SAMHSA) to launch an initiative to help ensure the safe use of the opioid methadone.
FDA launched the Safe Use Initiative to reduce preventable harm by medications, including opioids. FDA began working with U.S. Drug Enforcement Administration (DEA) and others to help educate the public on safe disposal of opioids.

New Drug

2010

FDA approved a new formulation of OxyContin designed to deter abuse.
FDA held joint advisory committee meeting to discuss its proposal for a class-wide REMS for Extended-Release (ER)/Long acting (LA) opioids, such as OxyContin.

Voluntary

2012

FDA implemented the ER/LA opioids REMS program, which includes voluntary training for
prescribers.

A Draft Guideline

Approx. January 9, 2013

On January 9, FDA issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties: Guidance for Industry: AbuseDeterrent
Opioids – Evaluation and Labeling.

Drug Safety Meeting

January 24 2013 - January 25, 2013

On January 24-25, FDA held a meeting of its Drug Safety and Risk Management Advisory
Committee to discuss the public health benefits and risks, including the potential for abuse, of
drugs containing hydrocodone either combined with other analgesics or as an antitussive.

Emergency Treatment

April 3, 2014

On April 3, FDA approved Evzio (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose. Naloxone is a medication that rapidly reverses the effects of opioid overdose.

The combination

July 23, 2014

On July 23, FDA approved Targiniq ER, an extended-release pain reliever that contains a combination of oxycodone and naloxone and has abuse-deterrent properties.

New Labeling

October 17, 2014

On October 17, FDA approved new labeling for Embeda (morphine sulfate and naltrexone
hydrochloride), an extended-release (ER) opioid analgesic to treat pain severe enough to require
daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are
inadequate. Embeda is the third ER opioid analgesic to be approved with labeling describing the
product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, AbuseDeterrent
Opioids – Evaluation and Labeling. The new labeling includes a claim indicating that
Embeda has properties that are expected to reduce oral and intranasal abuse when the product is
crushed.