Biovail’s new drug application (NDA) for this formulation was accepted for review by the FDA in May 2004. The approvable letter involves the resolution of labeling issues only, including resolution of a final trademarked name for the product. Biovail anticipates resolving these issues with the FDA shortly.
Subject to final FDA approval, Biovail’s orally disintegrating tablet (ODT) version of immediate-release tramadol hydrochloride will be available in 50mg tablets by prescription only.
The new formulation will be of particular benefit to patients who have difficulty swallowing tablets, or those who do not always have access to water. A study of the American population concluded that nearly 40% 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 also benefit from the immediate orally dissolving tablet form.
Biovail is currently considering a number of commercialization alternatives and an appropriate trade name for the product and anticipates submitting a full response to the FDA’s approvable letter in the coming weeks.