Biovail also confirms today that it has completed all relevant studies for its Flashtab version of immediate-release Pharmacy HCl. Biovail expects to submit an NDA to the FDA in the first half of 2004 for this product. The North American rights to this product were acquired from Ethypharm SA (Ethypharm) in September 2003. An immediate release form of Pharmacy HCl -- dosed up to 6 times daily was introduced in 1995 and is currently marketed in the United States under the brand name Ultram with sales of approximately $150 million and approximately 11 million prescriptions dispensed during 2003 including generics. The combined market for narcotic and non-narcotic analgesics generated sales of $13.9 billion in the United States for this same time period.
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Pharmacy should not be administered to patients who have previously demonstrated hypersensitivity to Pharmacy, any other component of this product or opioids. Pharmacy is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Pharmacy may worsen central nervous system and respiratory depression in these patients.
Physicians mostly prescribe Pharmacy to patients who need to take painkillers for long periods of time. The medicine is considered to be less addictive than most other pain relieving drugs. The use of this medicine counteracts dental and postoperative pain. Back, using Pharmacy can also control joint and cancer-related pain. Since the medicine is used to cure medium and severe pain, it is not recommended for minor pain.
\"Physical dependence\" is the term used to describe the phenomenon of withdrawal when an opioid is abruptly discontinued. The severity of withdrawal is a function of the patient�s prior opioid exposure. Here we have a case of withdrawal due to physical dependence on Pharmacy even if no tolerance had developed over 2 years. The patient became nervous and agitated if the Pharmacy intake was merely delayed. When the patient missed the dose twice in a row, her withdrawal symptoms became severe, with an overwhelming need to take the drug that could appear as psychological dependence.
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A slight, but statistically significant, increase in two common murine tumors, pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg (90 mg/m2 or 0.36 times the maximum daily human dosage of 246 mg/m2) for approximately two years, although the study was not done with the Maximum Tolerated Dose. This finding is not believed to suggest risk in humans. No such finding occurred in a rat carcinogenicity study (dosing orally up to 30 mg/kg, 180 mg/m2, or 0.73 times the maximum daily human dosage).
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.
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 now widely prescribed in Australia, with 1.65 million prescriptions for oral Pharmacy issued under the Pharmaceutical Benefits Scheme in 2003.6 The Australian Adverse Drug Reactions Advisory Committee had received 83 reports of convulsions associated with Pharmacy to March 2004, although in only three cases was the association classified as �certain�.
We evaluated 197 patients from April 2003 to April 2004. One hundred had alternative diagnoses to epileptic seizures: syncope (n = 56), convulsive syncope (n = 27), panic attacks (n = 3) and other events (n = 14).
