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FDA shoots down Remoxy Approval Again – Slowing Down the Opioid Epidemic

A drug manufacturer’s attempts to get another opioid painkiller approved by the FDA has been shot down again this week. Durect Corporation and Pain Therapeutics, Inc. have been attempting for several years to get Remoxy ER approved by the FDA. The FDA once again rejected their claims, focusing on the company’s failure to adequately address the potential for abuse of these drugs as well as problems with the labeling on the drugs.

Despite Remoxy not being approved by the FDA, Durect is advertising the drug, claiming that the drug is “long-acting” and “tamper-resistant.” That part of the website did not state that the drug was only an investigational new drug and not authorized for marketing in the U.S., which made the advertising misleading, according to the FDA.

Opioids are a class of drugs that include prescription medications such as oxycodone, hydrocodone, and morphine, as well as the illicit drug heroin.

In the US alone, more than 15 million people abuse prescription drugs. It is estimated that between 26.4 million and 36 million people abuse opioids worldwide, with an estimated 2.1 million people in the United States suffering from substance use disorders related to prescription opioid pain relievers in 2012. Drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally-made fentanyl, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes.

The FDA is taking a harder look at opioid based drugs given the epidemic of abuse of prescription drugs in the United States. In February of this year, the FDA announced that it is strengthening the requirements for drug companies to generate post market data on the long-term impact of using ER/LA opioids. The FDA also recently announced the 2016 Naloxone App Competition, seeking to develop innovative technologies to combat this epidemic.

Legal remedies may also be available to those who have become addicted to opioids or have lost a love one as a result of addiction. Opioid class actions have been filed on behalf of users of a number of prescription painkillers—including oxycodone (OxyContin) and propoxyphene (Darvon, Darvocet). These lawsuits sought compensation and medical monitoring costs for patients who were injured after using these prescription painkillers. Unfortunately, these lawsuits did not have the necessary deterrent effect and drug manufacturers continue to push these drugs when less addictive, safer alternatives are available. There have also been allegations that drug manufacturers have encouraged the use of opioid painkillers for off-label uses, putting the health of patients at risk.

Doctors may also improperly prescribe painkillers to their patients, increasing their risk of addiction, overdose, or other complications. While most doctors responsibly diagnose their patients who suffer from long term pain and monitor their valid drug needs, exceptions always exist, such as the Tuscaloosa doctor who was recently arrested on opium trafficking charges related to the over prescription of hundreds of prescription pain pills.

If you or a loved one suffer from addiction to prescription medications, seek treatment and help. Treatment options are available through the Substance Abuse and Mental Health Services Administration hotline at 1-800-662-4357 or at

If you’ve lost a loved one as a result of the overprescription or abuse of these drugs, there may be legal remedies available. Contact an attorney to protect your rights.


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