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news.The FDA has requested additional clinical trial data from Biovail Corporation to support the marketing application of its new pain drug, Tramadol ER. The regulatory setback sent Biovail's shares down by over 10%.
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Biovail’s original application for an extended-release, once-daily formulation of tramadol hydrochloride, intended for the treatment of moderate and moderately severe pain, was submitted in December 2003. Additional clinical testing of the drug could now delay its launch by more than a year.
The FDA had issued an “approvable” letter in response to Biovail’s new drug application. This gave way to suggestions that no more data was required. The regulator, however, requested further study information upon reviewing Biovail’s response to the approvable letter.
Biovail said that it would immediately undertake a clinical trial to address the FDA’s comments, with the intention of submitting the new data in late 2005 or early 2006. A six-month review by the FDA could then clear the drug for sale in the second half of 2006.
The Mississauga-based pharmaceutical firm also stated that it planned to meet with the US regulator to discuss its available options.