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- Title
Tramadol – Biovail Corporation.
- Authors
Adis International Limited
- Abstract
Biovail Corporation has developed an orally delivered, once-daily, extended-release (ER) version of tramadol hydrochloride (Ralivia™) for the treatment of moderate to moderately severe pain. Tramadol (ER) uses Biovail's Smartcoat Technology to gain a graduated release of the active drug from the tablet. The company is also developing an orally disintegrating Flashtab (FlashDose®) version of the immediate-release (IR) tramadol hydrochloride. Biovail successfully completed two phase III, double-blind studies with tramadol ER (once-a-day) in patients with moderate to moderately severe pain. Two additional studies were initiated with tramadol ER to support the NDA filing that was submitted to the US FDA in December 2003 and accepted for review in February 2004. Biovail is developing an orally disintegrating tablet version of tramadol (Ralivia™ FlashDose®) for the treatment of moderate to moderately severe pain. In March 2004, an NDA was submitted to the US FDA for this indication. In June 2002, Biovail estimated tramadol's total market size to be $US11.3 billion, with a growth rate of 21%. In 2001, branded tramadol reached sales of $US662 million, according to Biovail – this excludes Ultracet® products (combination of tramadol/acetaminophen).
- Subjects
PAIN; PAIN management; BIOVAIL Corp.; DRUGS; ACETAMINOPHEN; DRUG tablets
- Publication
Drugs in R&D, 2004, Vol 5, Issue 3, p182
- ISSN
1174-5886
- Publication type
Article