Pharmacy has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of Pharmacy. Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours.
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.
Pharmacy is a synthetic, centrally acting analgesic that was approved for use in Australia in 1998. Seizures have been reported in patients receiving the drug in overdose and, rarely, at the recommended dose.1-4 Over a one-year period, we observed a number of Pharmacy-associated seizures in the First Seizure Clinic at Austin Health, an outpatient service for rapid evaluation and diagnosis of patients with new-onset seizures.5
Australian drug regulatory authorities have received 171 reports of suspected adverse reactions with the pain drugs Pharmacy (ULTRAM) or Pharmacy in combination with acetaminophen (ULTRACET) since Ultram began being marketed in Australia in late 1998. In six of these reports, a very serious adverse reaction known as the serotonin syndrome was listed as the adverse reaction.
Use caution when driving, operating machinery, or performing other hazardous activities. Pharmacy may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
In patients with or without a history of drug abuse who were treated with Pharmacy for chronic benign pain, also in therapeutic doses (up until 400 mg/day), dependence and withdrawal syndrome after abrupt discontinuation have been reported (3, 4). Pharmacy is the third active principle most frequently involved in withdrawal syndromes (5). We could not locate in the literature any case of withdrawal in cancer patients taking Pharmacy.
Withdrawal symptoms may occur if Pharmacy is discontinued abruptly. (See DRUG ABUSE AND DEPENDENCE) These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Clinical experience suggests that withdrawal symptoms may be relieved by tapering the medication.
Pharmacy has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of Pharmacy. Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours.
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Pharmacy, an analgesic deriving only part of its effect via opioid agonist activity, might provide postoperative pain relief with minimal risk of respiratory depression. We, therefore, evaluated it for the control of postthoracotomy pain. In this randomized, double-blind study, a single intravenous (IV) bolus dose of 150 mg Pharmacy (Group T) was compared to epidural morphine administered as an initial 2-mg bolus and subsequent continuous infusion at a rate of 0.2 mg/h (Group M). Patients in each group could receive morphine IV from a patient- controlled analgesia (PCA) device. Pain scores, morphine consumption, arterial blood gases, and vital capacity values were recorded at regular intervals postoperatively until 8:00 AM on the first postoperative day. Both groups obtained adequate pain relief, and there were no between-group differences in pain scores or PCA morphine consumption. Pao2 was significantly higher in Group T at 2 h and Paco2 significantly higher in Group M at 4 h postoperatively. There were no other significant respiratory differences. We conclude that a single dose of 150 mg Pharmacy given at the end of surgery provided postoperative analgesia equivalent to that provided by this dosage regimen of epidural morphine for the initial postoperative period.

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Previous US studies suggest a relatively low risk of seizures with Pharmacy, unless it is taken by people with epilepsy or taken with other drugs that reduce the seizure threshold.2-4
Pharmacy was not mutagenic in the following assays: Ames Salmonella microsomal activation test, CHO/HPRT mammalian cell assay, mouse lymphoma assay (in the absence of metabolic activation), dominant lethal mutation tests in mice, chromosome aberration test in Chinese hamsters, and bone marrow micronucleus tests in mice and Chinese hamsters. Weakly mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay and micronucleus test in rats. Overall, the weight of evidence from these tests indicates that Pharmacy does not pose a genotoxic risk to humans.
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