History
Tapentadol was developed by Grünenthal in conjunction with Johnson & Johnson Pharmaceutical Research and Development. It is being marketed as immediate release oral tablets of 50 mg, 75 mg, and 100 mg under the brand name Nucynta.
It is the first new drug of the centrally acting analgesic class approved in the United States in more than 25 years. Internationally, tapentadol's status is in various stages of development at this time.
- On 23 January 2008, a New Drug Application (NDA) for tapentadol was submitted to the United States Food and Drug Administration.
- On 21 November 2008, Johnson & Johnson announced that it has received approval for immediate-release tapentadol tablets.
- On 17 February 2009 the Drug Enforcement Administration proposed a rule which would add tapentadol to Schedule II of the Controlled Substances Act of 1970. The original commercial release date for tapentadol was planned for 17 March 2009; however, the placement of the compound in Schedule II interrupted commercial development. It was the manufacturer's intention to have tapentadol approved as a Schedule III compound, based upon limited preclinical animal data that show a reduced liability for abuse and tolerance compared with morphine.
- On 22 June 2009, the Drug Enforcement Administration approved the proposal to make tapentadol schedule II under the Controlled Substance Act.
- On 23 June 2009, after having received approval from the FDA and DEA, tapentadol became available for prescription on the US market. It is available in immediate-release oral doses of 50, 75, and 100 mg.
- On 10 August 2010, the European decentralised procedure regarding tapentadol concluded positively, which will result in the granting of national marketing authorisations in 26 European markets. Tapentadol will then be available as an oral, solid, immediate-release formulation (tablets) for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics, and an oral, solid, prolonged-release formulation (tablets) for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics.
- On 28 March 2011 the United Kingdom made tapentadol a Class A controlled drug.
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