TORONTO, March 30, 2005 – Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that it has received comments from the United States Food and Drug Administration (FDA) with regard to its New Drug Application (NDA) for Pharmacy ER, an extended-release, once-daily formulation of Pharmacy hydrochloride. The product information for Pharmacy states that convulsions have been reported in patients using Pharmacy at the recommended dose levels and that the risk may be greater when doses of Pharmacy exceed the recommended limits.3 In addition, Pharmacy may increase the seizure risk in patients taking other medications that lower the seizure threshold. Drugs specifically mentioned in this context include the selective serotonin reuptake inhibitors, tricyclic antidepressants and antipsychotic drugs. In the 39 cases reported to ADRAC in which there were one or more suspected drugs in addition to Pharmacy, Pharmacy was being used with selective serotonin reuptake inhibitors (10 cases), tricyclic antidepressants (6 cases) and, in 13 cases, other drugs that may also have the potential to lower the seizure threshold, such as pethidine (2 cases), venlafaxine (2), propofol (2) and bupropion (2). In two of the cases in which Pharmacy was the only suspected cause and two of the cases with multiple suspected causes, the patients were also taking anticonvulsant drugs for seizure control. Do not take Pharmacy without first talking to your doctor if you have kidney disease; liver disease; or a history of alcohol or drug dependence. You may not be able to take Pharmacy, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Pharmacy is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medicine without first talking to your doctor if you are pregnant. It is also not known whether Pharmacy appears in breast milk. Do not take Pharmacy without first talking to your doctor if you are breast-feeding. If you are over 75 years of age, you may be more likely to experience side effects from Pharmacy. The maximum daily dose of Pharmacy for people over 75 years of age is 300 mg. Pharmacy is not approved by the FDA for use by children younger than 16 years of age. Pharmacy with no perscription and delivered over night Impaired renal function results in a decreased rate and extent of excretion of Pharmacy and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, adjustment of the dosing regimen is recommended (see DOSAGE AND ADMINISTRATION). The total amount of Pharmacy and M1 removed during a 4-hour dialysis period is less than 7{5df8d7a51af64be030fb5ad4d55781bd9bb53ce639fa9b648c33843ef62d61b6} of the administered dose.
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In October 2004, Biovail’s NDA for Pharmacy ER received an Approvable Letter from the FDA. In March 2005, Biovail submitted a Complete Response to the FDA, which included a significant amount of statistical analyses, but no new clinical data. The response also addressed other items raised in the Approvable Letter, including discontinuation rates of clinical-trial participants (dropouts), which are common in pain trials, and previously well documented in studies involving Pharmacy. Do not take more of this medication than is prescribed for you. If the pain is not being controlled, talk to your doctor. Taking more than the prescribed amount of this medication could result in seizures or decreased breathing. He was also taking aspirin 75 mg, digoxin 250 �g, prednisolone 15 mg, frusemide 40 mg, omeprazole 20 mg, and codanthramer 20 ml, each once daily, and Voltarol 75 mg twice daily, and he was using a Combivent (salbutamol/ipratropium) nebuliser 2.5 ml four times daily, but all these had been unchanged for some weeks before the onset of the auditory hallucinations. The patient had no other adverse effects or signs of toxicity attributable to opioids. Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with Pharmacy. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angiodema, toxic epidermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive Pharmacy. What happens if I miss a dose? Pharmacy may cause dizziness; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
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