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The FDA has acknowledged that Biovail’s Complete Response to the Pharmacy ER Approvable Letter is a Class 2 response, which is therefore subject to a six-month review. The FDA has also advised that, upon preliminary review, it is of the opinion that additional clinical trial data will be required. Biovail’s view is that the clinical data contained within the original NDA and the March 2005 Complete Response fully support 505(b)(2) filing requirements, and the Company is considering a number of options. Biovail expects to meet with the FDA to discuss these options promptly. In the meantime, however, Biovail will immediately undertake a clinical program to address the FDA’s comments. Biovail anticipates the submission of new clinical data in late 2005 or early 2006. Biovail believes that a new six-month review period would then be initiated.
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.
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.
The volume of distribution of Pharmacy was 2.6 and 2.9 liters/kg in male and female subjects, respectively, following a 100 mg intravenous dose. The binding of Pharmacy to human plasma proteins is approximately 20{5df8d7a51af64be030fb5ad4d55781bd9bb53ce639fa9b648c33843ef62d61b6} and binding also appears to be independent of concentration up to 10 ?g/mL. Saturation of plasma protein binding occurs only at concentrations outside the clinically relevant range.
Furthermore, Biovail today announced that it has acquired North American rights to Ethypharm SA’s (Ethypharm) Flashtab combination Pharmacy and acetaminophen (Flashtab Pharmacy/acetaminophen) product, which complements Biovail’s September 2003 purchase from Ethypharm of Flashtab Pharmacy. A current combination Pharmacy and acetaminophen product is sold under the Ultracet brand for the treatment of short-term management of acute pain by a division of J&J and had sales of $262 million in the United States in 2003. Flashtab Pharmacy/acetaminophen may offer the convenience of an Orally Disintegrating Tablet (ODT or Flashtab or Flash Dose) for an acute pain use. This dosage presentation may be particularly advantageous for a drug that is taken multiple times per day (up to 8 tablets per day) and is further evidence of Biovail’s commitment to providing innovative treatment options for pain management.
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.
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Pharmacy may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.
Do not drink alcohol while taking Pharmacy. Alcohol may cause a dangerous decrease in breathing and/or liver problems when used during treatment with Pharmacy.
Pharmacy has been given in single oral doses of 50, 75, and 100 mg to patients with pain following surgical procedures and pain following oral surgery (extraction of impacted molars).
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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.