ROUND ROCK, TEXAS – February 9, 2010 – Cerilliant, in cooperation with Tapentadol patent holders, introduces certified reference standards of the new pain management drug, Tapentadol and its primary metabolite, N-Desmethyltapentadol in Cerilliant’s accurate and convenient Snap-N-Spike® | Snap-N-Shoot® format.
Tapentadol, sold under the brand name NUCYNTATM, is a new centrally-acting analgesic and is FDA approved for the treatment of moderate to severe acute pain. It is the first new drug of the centrally-acting analgesic class approved in the United States in more than 25 years. More than 25 million Americans experience acute pain each year as a result of injuries or surgery, and acute pain is the most common reason people seek medical attention. Tapentadol is classified as a schedule II drug under the Controlled Substance Act.
Tapentadol is covered by one or more U.S. patents making it illegal under U.S. patent law for anyone other than the patent holder and its licensees and authorized vendors to make, use, or sell it. Contrary to popular opinion, U.S. patent law makes no exception for small or research quantities. According to Cerilliant CEO, Sherri Pogue, “with the introduction of these new authorized certified Tapentadol reference standards, laboratories needing reference materials for pain prescription monitoring or toxicology analysis no longer need to resort to crushing pills to produce their own reference standard.”
The company also announced that deuterium-labeled internal standards and additional metabolites of Tapentadol are coming soon to round out its Tapentadol offering and provide laboratories options in determining which standard is most appropriate for their application and testing methods.
Cerilliant’s Tapentadol reference standards are manufactured and certified to the highest industry standards including ISO Guide 34 and ISO/IEC 17025 and are suitable for qualitative or quantitative applications including as assay standards in pharmaceutical analysis, pain prescription monitoring, and toxicology applications. These standards are classified as “certified reference materials” in accordance with ISO requirements. Cerilliant’s quality system also incorporates FDA’s cGMP and GLP guidelines as well as ISO 9001:2008 requirements making these standards suitable for any analytical application across international borders.
Cerilliant has received DEA exemptions for these new Snap-N-Spike® | Snap-N-Shoot® standards allowing laboratories to order them without DEA paperwork.
To learn more about Tapentadol visit: http://www.jnj.com/connect/news/all/20090623_080000
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