Tapentadol hydrochloride
Potential health benefits   2008
APPROVAL / USE / INDICATIONS

The U.S. Food and Drug Administration has approved Tapentadol hydrochloride,
an immediate-release oral tablet for the relief of moderate to severe acute pain.

STRENGTHS
Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50
mg, 75 mg, or 100 mg.

MECHANISM

Tapentadol acts in two ways, opioid (narcotic) and non-opioid. It affects the brain
and body primarily by activating opioid receptors in the brain, spinal cord and
gastrointestinal tract. In addition, Tapentadol inhibits the reuptake of the brain
chemical norepinephrine which possibly has an analgesic effect.

Acute pain is a symptom of many medical conditions and can significantly interfere
with a person's quality of life and general functioning. Opioids are considered safe
and effective in selected patients but can cause dependence, abuse, and addiction.
All patients treated with opioids require careful monitoring by their health care
professional for signs of abuse and addiction, and to determine when opioid
analgesics are no longer needed.

COMMON SIDE EFFECTS

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.

SAFETY ISSUES / CONTRAINDICATION

Tapentadol is contraindicated in any situation where mu-opioid agonists are
contraindicated (i.e., significant respiratory depression, acute or severe bronchial
asthma or hypercapnia); in patients with paralytic ileus; or in patients currently using
or within 14 days of using monoamine oxidase inhibitors (MAOI).

Due to its mu-opioid receptor agonism, respiratory depression is a possible adverse
event of tapentadol. Tapentadol should be administered with caution to the elderly,
debilitated patients, and patients with conditions accompanied by hypoxia,
hypercapnia or decreased respiratory reserve such as: asthma, chronic obstructive
pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome,
myxedema, kyphoscoliosis, CNS depression, or coma. [2]

MANUFACTURER

Tapentadol is manufactured by Janssen Ortho, LLC, Gurabo, PR.

SALES/MARKET

The new Pharmacor report entitled Chronic Low Back Pain finds that Pfizer's
Tanezumab will garner 25 percent of overall Chronic Low Back pain market sales by
2017 in the United States, France, Germany, Italy, Spain, the United Kingdom and
Japan. Additionally, Johnson & Johnson/Grunenthal's controlled-release formulation
of Tapentadol will capture more than 80 percent of sales in the dual-acting opioid
class by 2017, owing to its anticipated advantage in efficacy over Tramadol. [1]

Reference
[1] Overall market will increase to US$ 6.9 billion over the next decade, according to
a new report from Decision Resources, pharmalicensing.com, 9th December 2008.
[2] FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to
Severe Acute Pain Nov. 21 2008 /PRNewswire
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