FDA approves Pfizer's addiction-fighting pain pill as US heroin deaths soar
- Embeda (morphine and naltrexone) is an opioid designed to treat pain severe enough to require long-term, around-the-clock analgesia while deterring drug abuse. Traditionally, opioids have been easy to abuse, making them subject to restrictive prescribing.
- Embeda is not designed for pro re nata (as-needed) pain relief. It was initially approved in August 2009 and withdrawn voluntarily in March 2011 due to stability concerns related to manufacturing. It was subsequently reintroduced in November 2013.
- According to new government statistics released last week, prescription drug deaths related to painkillers such as OxyContin and Vicodin dropped by 5% in 2012, the first drop in more than a decade. But deaths from heroin concurrently soared by a staggering 35%, leading one health expert to declare that "we are not winning" the war on opiate addiction.
Embeda is designed to provide effective pain relief, while also being unattractive as a way to get high by crushing the pills and snorting or injecting them. When crushed, the naltrexone blocks some of the euphoric effects of the morphine. In the worst cases, crushing the pills can lead to withdrawal in opioid-dependent individuals. However, Embeda can still be abused by swallowing more than the prescribed dose, possibly leading to death or withdrawal.
The approval of Embeda as an opioid with abuse-deterrent properties was based on a clinical trial of 547 patients with osteoarthritis. In addition to this data, the FDA is requiring continued post-marketing surveillance to assess the ability of the built-in deterrence feature to discourage abuse.
The trend towards these types of addiction-fighting pain pills will likely persist as the U.S. tries to grapple with its opiate and heroin addiction epidemic.