Development and Regulation of Abuse-Deterrent Opioid Medications – FDA Public Meeting

fdaThe FDA is hosting a public meeting on October 30 and 31, 2014 to discuss the development, assessment, and regulation of abuse-deterrent formulations of opioid medications. The meeting will focus on scientific and technical issues related to the development and in vitro assessment of these products, as well as FDA’s approach towards assessing the benefits and risks of all opioid medications, including those with abuse-deterrent properties.

This year the FDA has approved three opioid analgesics with an abuse-deterrent label. In April, 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. Evzio is the first auto-injector designed to deliver a dose of naloxone outside of a healthcare setting.

On July 23, FDA approved Targiniq ER, an extended-release pain reliever that contains a combination of oxycodone and naloxone. Targiniq ER is the second extended-release/long-acting (ER/LA) opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties.

This month the 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. 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.

Links to FDA meeting materials and webcast information can be found at
http://www.fda.gov/Drugs/NewsEvents/ucm408607.htm

October 31, 2014 | Drugs . FDA . Opioids . Substance abuse |