Biovail Corporation has received an Approval Letter from the United States Food & Drug Administration (FDA) for Tramadol ODT (tramadol hydrochloride), an orally disintegrating tablet version of the analgesic medication tramadol hydrochloride in 50mg dosage format, intended for the treatment of moderate to moderately severe pain in adults.

In March, Biovail filed a Complete Response to address routine matters raised in the Approvable Letter received from the FDA in early January.
The approval of Tramadol ODT is the first milestone in Biovail's development of a franchise of pain medications. The Company received an Approvable Letter for its New Drug Application for a once-daily extended-release formulation of tramadol HCl in October 2004, stated a release.

"Patients may benefit from the convenience of Tramadol in an orally disintegrating dosage format - particularly those who have difficulty swallowing tablets, or those who may not, or do not, always have access to water," said Biovail CEO Dr. Douglas Squires. "The approval of Tramadol ODT is a further establishment of Biovail's patented oral disintegrating tablet technologies, such as FlashDose and Flashtab, and their application to making medicines more acceptable and convenient for patients," he added.

A 2004 study of the American population concluded that nearly 40 per cent of adults have experienced problems with swallowing tablets - and a significant proportion of those fail to comply properly with their prescribed and ongoing dosage. Conditions such as post-procedural pain with swelling, associated with swallowing impairment, that require acute analgesic treatment, will benefit from the immediate orally dissolving tablet form.