Johnson & Johnson has attained approval for their long standing opioid Nucynta in extended release format by the U.S. Food and Drug Administration. Nucynta has a high potential for abuse, and users may become psychologically or physically dependent on the drug so this approval is somewhat controversial.

Crushing an opioid often makes it easier to abuse, and there has been a movement in the pharmaceutical industry to make more abuse resistant opioids. Last October, J&J said the FDA had requested additional information on the conversion of the extended-release formulation used in prior studies to a version that is designed to increase resistance to breaking or crushing. Nucynta is considered a schedule II drug.

Schedule II drugs are a category of drugs considered to have a strong potential for abuse or addiction but that have legitimate medical use. Among the substances so classified by the Drug Enforcement Agency are morphine, cocaine, pentobarbital, oxycodone, alphaprodine, and methadone.

Nucynta is intended to be an oral medication taken twice daily to manage moderate-to-severe chronic pain in adults. The immediate release version of the drug was approved in 2008 and is sold as a treatment for severe acute pain in patients 18 and older.

Here is a little history on opioids. Opioids are the most powerful known pain relievers. Their use and abuse date back to antiquity. The pain relieving and euphoric effects of opioids were known to Sumerians (4000 BC) and Egyptians (2000 BC).

International awareness of opioid abuse was stimulated early in the 20th century when President Theodore Roosevelt convened the Shanghai Opium Commission in 1909 to aid the Chinese empire in stamping out opioid addiction, especially opium smoking.

In 1913, President Woodrow Wilson’s administration drafted legislation to limit the use of narcotics, requiring prescription in good faith; this became effective in 1915. Legitimate providers of narcotics and cocaine preparations were required to register with the Bureau of Internal Revenue and were mandated to keep records of transactions.

In 1917, the Harrison Narcotics Tax Act was interpreted by the courts in such a way that opioids could not be prescribed for the treatment of opioid addiction.

In the 1960s, Dole and Nyswander demonstrated that methadone was an effective treatment for opioid addiction.

In 1974, the Narcotic Addict Treatment Act allowed regulated methadone treatment for opioid addiction, but made off-label use of opioids illegal.

Most recently in 2000, the Drug Addiction Treatment Act (DATA) allowed qualified physicians to use Schedule III, IV, or V drugs for the treatment of opioid dependence.

Because overdoses usually occur in the presence of other people and because medical care is often not sought or is sought too late, at-home naloxone programs have been piloted in several countries. This is a controversial treatment that raises concerns about condoning heroin use, discouraging medical care, and producing side effects that cannot be managed at home. However, the efficacy of these pilot programs should be carefully monitored, as the potential for reducing mortality is high.

Like other drugs with mu-opioid agonist activity, Nucynta is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment. Nucynta is contraindicated in patients who have or are suspected to have paralytic ileus. Nucynta is also contraindicated in patients currently using or within 14 days of using monoamine oxidase inhibitors (MAOIs) due to potential additive effects on norepinephrine levels, which may result in adverse cardiovascular events.

Written by Sy Kraft