Tramadol--Biovail Corporation.

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 11.3 billion US dollars, with a growth rate of 21%. In 2001, branded tramadol reached sales of 662 million US dollars, according to Biovail--this excludes Ultracet products (combination of tramadol/acetaminophen).