Tramadol ODT

Biovail Submits NDA for Ralivia FlashDose

TORONTO, Canada, March 11, 2004 -- Biovail Corporation (NYSE:BVF) (TSX:BVF) announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for Ralivia FlashDose, an orally disintegrating tablet version of the analgesic medication tramadol hydrochloride, intended for the treatment of moderate to moderately severe pain. Biovail recently announced the filing of Ralivia ER a once daily, extended release form of tramadol.

Tramadol is currently sold in the United States under the brand name Ultram(R) with approximately 11 million prescriptions dispensed during for the twelve months ended December 31, 2003 including generics. Total sales for tramadol immediate release products were $150 million for the same period. The combined market for narcotic and non-narcotic analgesics generated sales of $13.9 billion in the United States for this same time period.

Eugene Melnyk, Chairman of the Board and Chief Executive Officer commented, "The filing of Ralivia FlashDose is very significant, complementing our filing of Ralivia ER and marking our development of a franchise of pain medications. We continue development of a FlashDose form of a tramadol/acetaminophen combination product. The submission of this important product is a further establishment of Biovail's FlashDose technology and its application to making medicines more acceptable and convenient for patients." Biovail is evaluating options for commercialization of the pain franchise and is currently in discussions with multiple potential partners regarding out-licensing Ralivia ER alone or in conjunction with Biovail's orally disintegrating pain products.

The application for Ralivia FlashDose was submitted under the provisions of Section 505(b)(2) of the Food, Drug and Cosmetic Act. The goal of Biovail's biopharmaceutics program was to develop a formulation that would deliver an equivalent amount of drug to the systemic circulation as the listed drug Ultram(R), but in a dosage form that offers a choice of administration with or without water, thereby providing a benefit to patients of comparable efficacy and safety with a greatly simplified dosing regimen and potentially higher compliance.

Subject to FDA approval, Ralivia FlashDose will be available in 50mg, tablets by prescription only. Patients will benefit from the convenience of this FlashDose form -- particularly those who have difficulty swallowing tablets or may do not always have access to water. A recent 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 benefit from the immediate orally dissolving tablet form.

Swallowing difficulty or dysphagia itself is a frequent complication of a number of diseases including stroke, Parkinson's disease and commonly associated with the progression of aging and is a major problem in the care of the elderly. Dysphagia and swallowing impairment is a common problem in populations of elderly and infirm patients with estimates of the disorder affecting 40-50% of patients in nursing home facilities frequently receiving medicated analgesia.

Tramadol is one of a number of analgesics, which are among the most effective medications for the treatment of chronic pain. Tramadol's minimal propensity to induce adverse effects is an advantage over morphine-like agents. Relative to morphine, tramadol causes less dependence and less respiratory depression.

Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies.

For further information, please visit www.biovail.com.

Source: Biovail Corporation

Related Articles:

Biovail Receives Approval Letter From FDA For Tramadol ODT; Oral Disintegrating Tablet Version to Provide Treatment Option for Those Who Suffer from Moderate to Moderately Severe Pain - May 6, 2005

Tramadol ODT Biovail Corporation - Treatment for Moderate to Moderately Severe Pain - May 5, 2005

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