Tapentadol - Become Pain Free!
Tapentadol is an opioid analgesic, indicated for severe pain management, on a daily or around the clock need for treatment and long-term opioid treatment, for which alternative treatment options are inadequate. Tapentadol is also indicated for neuropathic pain associated with diabetic peripheral neuropathy. It is widely used for management of acute, chronic, and cancer related pain among patients and is available legally on prescription. Nucynta ER is the first and only FDA-approved long-acting opioid analgesic designed to control both, nociceptive pain and neuropathic pain associated with diabetic peripheral neuropathy. Nucynta is available as Palexia outside the U.S. territory. Nucynta ER is contraindicated for patients suffering from significant respiratory depression, known or suspected gastrointestinal obstruction, acute or severe bronchial asthma or hypercarbia, including paralytic ileus, concurrent use of monoamine oxidase inhibitors (MAOIs), and Hypersensitivity (e.g. anaphylaxis, angioedema) to tapentadol or to any other ingredients of the product or use of MAOIs within a period of 14 days.
Rising incidence of cancer and diabetic neuropathy in the Middle East is expected to fuel growth of the Middle East tapentadol market
According to data published in World Journal of Diabetes in 2016, the Middle Eastern and North African regions are estimated to have the second-highest rate of diabetes in the world, in turn, increasing prevalence of neuropathic pain. In Arab World, the prevalence of diabetes is projected to increase to 96.2% by 2035, as estimated by World Journal of Diabetes in 2016. Furthermore, the World Health Organization (WHO) estimated that in the Eastern Mediterranean region, including Middle East, recorded 555,318 new cases of cancer in 2012, which is projected to rise to 961,098 by 2030. Thus determining that the Eastern Mediterranean region is expected to have the highest relative increase of cancer cases among all regions in the world. According to Journal of Taibah University Medical Sciences, 2016, the number of people suffering from diabetic neuropathic pain in countries of the Middle East were as follows:
The Middle East tapentadol market was valued at US$ 0.82 million in 2016 and is expected to witness a robust CAGR of 6.1% over the forecast period (2017-2025).
Figure 1. Tapentadol related important events since discovery
Absence of gold standard opioid therapy for neuropathic pain other than tapentadol is expected to fuel the Middle East tapentadol market growth
Neuropathic pain is caused by a dysfunction of or lesion to the central or peripheral nervous system and it is chronic in nature with a complex pathophysiology. NUCYNTA ER (tapentadol) is used in the treatment of neuropathic pain, if the pain is severe enough to require tapentadol daily, whereas it is also used in long-term opioid treatment for which alternative treatment options are inadequate. There is low quality evidence that the oral tramadol has any important beneficial effect on pain for people suffering from severe or moderate neuropathic pain, whereas the main indication of tapentadol is to treat the diabetic neuropathic pain. This proves that other opioids such as fentanyl, oxycodone, tramadol, and oxymorphone are not as effective as tapentadol in the treatment of neuropathic pain.
The U.S. Food & Drug Administration (FDA) tapentadol approval timeline
Major players operating in the tapentadol market include Depomed, Inc., Janssen Pharmaceutical, Inc., Grünenthal, and Allergan Plc.
Pain related diseases such as cancer and diabetic neuropathy are highly prevalent in the Middle East where opioid such as fentanyl, morphine, oxycodone, and pethidine are used for the treatment. These opioids possess potent analgesic action, however, are highly addictive, whereas, tapentadol is mildly addictive and has higher safety and efficacy levels. Tapentadol may prove to be an effective alternative for pain management in Middle East region, where, opioid abuse is an issue. Nucynta extended release tablets is the only patented product available for tapentadol. Depomed, Inc. holds the patent for distribution and development of the drug tapentadol in the U.S. Janssen Pharmaceuticals along with Grünenthal GmbH, developer of the tapentadol molecule, filed a patent infringement lawsuit in the U.S., in 2013, against generic tapentadol manufacturers. Janssen Pharmaceuticals divested the drug development and distribution rights in the U.S. territory to Depomed, Inc. in 2015. Depomed won the case in April 2017 and all generics were subsequently pulled out of the market and are now banned till the patent expiry of tapentadol in 2025.
The Middle East tapentadol market is expected to gain significant traction, provided that the product distribution is restructured by the patent holder, globally. Support from the regulatory bodies in the Middle East, and increase in accessibility of tapentadol is expected to support growth of Middle East tapentadol market. Absence of major distribution channel for tapentadol in the Middle East has drastically reduced the import options. This provides immense opportunities for local players such as Teva Pharmaceutical Industries Ltd. to set up a distribution channel with the drug patent holder. Tapentadol is the only U.S. Food & Drug Administration approved opioid drug for treatment of diabetic neuropathic pain. Currently, only adults can consume tapentadol due to high therapeutic efficacy, which is not recommended for children. Whereas, ongoing clinical trials are expected to culminate in tapentadol being subjected to pediatric use, positive result of which, are expected to fuel growth of the Middle East tapentadol market over the forecast period.
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