FDA Approves Tapentadol Hydrochloride, The First New Drug In Its Class In More Than 25 Years for the Relief of Moderate to Severe Acute Pain

According to the American Pain Foundation, more than 25 million Americans experience acute pain each year as a result of injuries or surgeries, and a recent study estimated that 42 percent of U.S. hospital emergency department visits were due to pain-related problems. Acute pain is a symptom of many medical conditions and can significantly interfere with a person’s quality of life and general functioning. Arthritis is the most common chronic debilitating disease in the United States (more than 43 million people or 1 in 6). Osteoarthritis of the knee is a very common and a major cause of disability.

The U.S. Food and Drug Administration (“FDA”), on November 24, 2008, approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain, cancer-related and other. A trade name has not yet been established. Currently available pharmacological treatment of pain includes the following analgesics: non-steroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase II (COX-II) inhibitors, acetaminophen and opioids.

Notwithstanding the numerous available analgesic medications, 60% to 80% of patients suffering from chronic pain are currently treated inadequately. It is hoped that Tapentadol will help fill the gap for those whose pain cannot be effectively controlled by existing medications. Tapentadol acts in two ways, opioid (narcotic) and non-opioid. It has a unique profile with two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition in a single molecule. It is being developed in immediate-release and extended-release formulations.

Tapentadol is manufactured by Janssen Ortho, LLC, Gurabo, PR. Tapentadol was developed by Grünenthal in conjunction with Johnson & Johnson Pharmaceutical Research and Development. The most common side effects from Tapentadol are nausea, dizziness, vomiting, and sleepiness. The labeling for Tapentadol includes warnings about the risk of respiratory depression; addictive depressive effects on the central nervous system when taken with alcohol, other opioids, or illicit drugs; and abuse potential.

A Johnson & Johnson press release notes that the approval was based on data from clinical studies involving more than 2100 patients, the. These phase 3 studies, presented at the 27th Annual Scientific Meeting of the American Pain Society in May, showed significant relief compared with placebo for patients undergoing bunionectomy, a common foot surgery; in pain from end-stage joint disease; and with low back pain or osteoarthritis of the hip or knee. It was generally well tolerated.

Johnson & Johsnon also notes that the new drug is contraindicated in any situation where mu-opioids are contraindicated, such as in significant respiratory depression, acute or severe bronchial asthma, or hypercapnia; in patients with paralytic ileus; or in those who are currently using or are within 14 days of using monoamine oxidase inhibitors (MAOIs). The drug should be prescribed “with care” in patients with a history of a seizure disorder or any condition that would put the patient at risk for seizures.

Importantly, the Johnson & Johnson release points out that a potentially life-threatening serotonin syndrome may occur with tapentadol, “particularly with concomitant use of serotonergic drugs such as [selective serotonin-reuptake inhibitors] SSRIs, [serotonin-norepinephrine-reuptake inhibitors] SNRIs, [tricyclic antidepressants] TCAs, MAOIs, and triptans and with drugs that impair metabolism of serotonin (including MAOIs).”

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