NDA for pain relief
Biovail Corporation has submitted a NDA to the 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 Corporation has submitted a NDA to the 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 US under the brand name Ultram with approximately 11m prescriptions dispensed during the twelve months to December 31, 2003 including generics. Total sales for tramadol immediate release products were worth $150m for the same period. The combined market for narcotic and non-narcotic analgesics generated sales of $13.9bn in the US for this same time period.
Eugene Melnyk, chairman of the Board and ceo 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 commercialisation 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.