Hope for chronic pain sufferers as new drug becomes available

From The Telegraph (UK):

Many people on opiate-based drugs for chronic pain suffer unpleasant side effects from them including constipation and vomiting.

A new drug called Palexia becomes available for doctors to prescribe today, which trials show could be tolerated by many more.

Pain management experts hope it will mean more patients sticking with their medication and getting the relief they need.

Palexia, the brand name of the drug tapentadol, works in two ways. First, it works as a traditional opioid, stopping pain signals getting through nerve junctions in the spinal cord called synapses, and reducing the perception of pain in the brain itself.

Secondly, it works to stop pain messages being transmitted by reducing levels of a neurotransmitter called noradrenaline.

It is the first such painkiller on the British market to work in both these ways.

Posted: 5/17/2011 8:32:00 AM

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New Drug Application Submitted to FDA for Tapentadol Extended Release Tablets for Management of Chronic Pain

From Pharmaceutical Processing:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. has submitted a New Drug Application (NDA) to the FDA for tapentadol extended release (ER) tablets, an investigational oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older.

Chronic pain, defined as pain that persists for long periods of time - usually greater than three months - is a significant medical challenge in the United States. According to the National Institutes of Health (NIH), an estimated 100 million Americans suffer from chronic pain. If undertreated, chronic pain can impair an individual's ability to carry out daily activities.

Tapentadol ER is a novel investigational, centrally acting oral analgesic that binds to mu-opioid receptors and inhibits norepinephrine re-uptake. Although the exact mechanism of action is not known, these two mechanisms, which affect established pain pathways, are thought to be responsible for pain relief with tapentadol.

The submission is based on a full clinical development program for tapentadol ER. The program includes Phase 3 double-blind, randomized, active-and placebo-controlled studies. These clinical trials explored the efficacy and safety of tapentadol ER for the treatment of moderate to severe pain in patients with chronic osteoarthritis and low back pain, as well as in patients with diabetic peripheral neuropathic pain. In addition, a one-year, active-control open-label Phase 3 safety trial also was included.

Data from these studies provide evidence that tapentadol ER has efficacy to reduce moderate to severe chronic pain compared to placebo. The data also provide evidence of long-term safety and tolerability of tapentadol ER.

The tapentadol ER tablet formulation is designed to provide a high degree of mechanical resistance, such as to crushing or chewing.

Posted: 12/3/2009 9:49:00 AM

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