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news.The FDA has approved Biovail Corporation's orally disintegrating analgesic tablet Tramadol ODT, for the treatment of moderate to moderately severe pain in adults.
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In March, Biovail filed a complete response to address labeling issues raised in an approvable letter received in early January. The approval of Tramadol ODT (tramadol hydrochloride) is the first milestone in Biovail’s development of a franchise of pain medications.
A 2004 study of the US 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 benefit from the immediate orally dissolving tablet form.
Biovail believes a considerable market opportunity exists for Tramadol ODT in the US analgesia market, where sales for the 12 months ended March 30, 2005 were $14.3 billion. Over the same period, tramadol-based products generated revenues of $463.3 million and 19.4 million prescriptions.