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Bupropion and schizophreniaBupropion for smokersAbuse of bupropionBupropion Benefits Smoking CessationBupropion Or Patch For Smoking Cessation?

Dr. Horrigan, of GlaxoSmithKline, reported the results of the company’s multicenter randomized placebo-controlled trial of extended-release bupropion in 162 ADHD patients aged 18-60 years. The active group contained 81 patients and the placebo group contained 81 patients.
All patients began with a 150-mg dose given once daily in the morning. In weeks 2-4, patients received 300 mg each morning. In weeks 5-8, the dosage could be increased to 450 mg/day if there was less than a 30% improvement on the ADHD Rating Scale, or if the Clinical Global Impression-Improvement Scale score was greater than two, and if the patient was tolerating 300 mg/day. Dosages could be reduced to a 300 mg/day minimum if adverse events occurred.
By the end of the study, 70.4% of the patients in the active group were taking 450 mg/day, 28.4% were taking 300 mg/day, and 1.2% (only one patient) was taking 150 mg/day. The mean final dose of bupropion XL was 393 mg/day.
By week 5, 55% of patients taking the study drug had experienced at least a 30% reduction on both the inattentive and hyperactivity-impulsivity domains of the ADHD Rating Scale. The study indicated that patients experienced relief from symptoms compared with placebo. Previous studies have shown that serum levels of bupropion XL increase soon after an 8 a.m. dosing, rising to a peak level of 120 ng/mL from noon to 2 p.m., and slowly falling to around 60 ng/mL by 8 p.m. and 20 ng/mL by 8 a.m. the next day.
The most commonly reported adverse events were headache (17% bupropion vs. 14% placebo) and dry mouth (12% bupropion vs. 5% placebo), compared with 5% placebo. Other adverse events reported were nausea, nasopharyngitis, dizziness, constipation, somnolence, fatigue, irritability, and tinnitus. Most adverse events occurred in the first 2 weeks. Bupropion and placebo had equal effects on blood pressure and heart rate.
BY MICHELE G. SULLIVAN
Mid-Atlantic Bureau
COPYRIGHT 2004 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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The patients in Jorenby et al’s study received intensive counselling, which comprised more than three hours of face to face counselling and 80 minutes of telephone support over the 12 months. It is not realistic for the NHS to provide this level of support. The manufacturers are offering a telephone line for patients to ring for support, but this is not likely to be as effective in motivating and supporting patients. The high success rates reported by Jorenby et al are therefore unlikely to be repeated in day to day practice.
Britton and Jarvis could have pointed out that half of patients who successfully stop smoking with the aid of bupropion will start again within 12 months of coming off the drug. They could also have referred in more detail to the side effect profile and the number of patients for whom the drug will be unsuitable. Bupropion may have a 1 in 1000 risk of inducing seizures (product information from GlaxoWellcome, the manufacturer of the drug). This may be an acceptable risk for drugs to treat disease but is less so for lifestyle drugs.
Bupropion may well prove to be a useful adjunct to smoking cessation, but I would have preferred a more balanced appraisal in a BMJ editorial.
Christopher Harrison general practitioner Barlow Medical Centre, Manchester M20 6TR charrison@doctors.org.uk
Competing interests: None declared.
[1] Britton J, Jarvis MJ. Bupropion: a new treatment for smokers BMJ 2000;321:65-6. (8 July.)
[2] Jorenby DE, Leischow SJ, Nides MA, Rennard SI, Johnston JA, Hughes AR, et al. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. N Engl J Med 1999;340:685-91.
Drug is almost identical in structure to diethylpropion, a controlled drug
EDITOR–Britton and Jarvis’s editorial on bupropion does not mention that the drug is an amphetamine derivative.[1] It is almost identical in structure to diethylpropion hydrochloride, which is a controlled (schedule 3) drug because of its supposed potential for misuse. Bupropion has been released in the United Kingdom on the strength of only two American clinical trials financed by the manufacturer. Many patients to whom it will be given will have addictive personalities. Shouldn’t the Medicines Control Agency rethink its decision?
When I asked the agency to explain the discrepancy regarding the classifications of the two drugs I was referred to the Home Office, whose advisers said that because bupropion is not a stimulant it need not be classified like diethylpropion. As the drugs are so similar in structure it would be surprising if one was a stimulant and one not. Certainly, dose related stimulation of the central nervous system occurs with bupropion in animals.[2] Both drugs come in a crushable tablet form, which facilitates parenteral misuse.
Drugs do not have to be stimulants for people to become dependent on them (for example, ethanol and diazepam), and not all stimulants give rise to dependency (only a few people say that caffeine withdrawal is a serious problem). And not all sympathomimetic drugs are stimulants (the appetite suppressant phenylpropanolamine, a sister sympathomimetic to bupropion and diethylpropion, is sold over the counter in the United States).
If bupropion is not a stimulant why does GlaxoWellcome’s product monograph list insomnia as its commonest side effect (occurring in just under half of patients)? And if it has none of the anorexigenic properties of the amphetamines why was the 11th congress on tobacco or health in Chicago on 6-11 August 2000 told that smokers taking bupropion gain less weight than those taking placebo (this information was also contained in the two clinical trials)?
A mass of evidence indicates that diethylpropion is safe and efficacious,[3] yet the Medicines Control Agency has made no objections to the European Commission’s current attempts to delicense it. Bupropion is being foisted on an unsuspecting British public with little evidence that it works much better than placebo.[4] The recommended dose of bupropion is much greater than that of diethylpropion. I suspect that a politically correct antismoking drug, however poorly researched and ineffective, will always be given the benefit of the doubt compared with a politically incorrect slimming drug, however safe and effective.
Herbert G Kinnell medical adviser Berkshire Diet Centre, Reading, Berkshire RG1 1SN
Competing interests: None declared.
[1] Britton J, Jarvis MJ. Bupropion: a new treatment for smokers BMJ 2000;321:65-6. (8 July.)

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We looked at popular culture first by doing Google searches for “Wellbutrin snort” and “snorting Wellbutrin.” Some Web sites describe the effects of snorting bupropion (www.erowid.org/experiences/exp.php?ID=9266) and some give advice on extracting bupropion from Wellbutrin SR tablets for the purpose of insufflation (http://bupropion.home.comcast.net). Wondering what has been published on this topic in the medical literature, we first searched the Cochrane Database of Systematic Reviews (www.cochrane.org/reviews) without result. We then searched Medline, combining “bupropion” and “abuse or misuse.”
The Evidence
Bupropion’s amphetaminelike abuse potential was suggested in preclinical trials in which animals substituted bupropion for amphetamine in a drug-discrimination task, and in another study in which it was self-administered intravenously by monkeys.
We were able to find two case reports (N. Engl. J. Med. 2002;347:951;J. Child Adol. Psychopharm. 2004;14:157-8) that described adolescents who insufflated bupropion in an attempt to obtain an amphetaminelike effect. One 16-year-old boy insufflated 600 mg of sustained-release bupropion and experienced a seizure. A 15-year-old girl snorted an unspecified amount of sustained-release bupropion and reported a marijuanalike buzz that only lasted a few seconds.
In a double-blind crossover study conducted to determine the amphetaminelike abuse potential of bupropion, 13 male subjects (aged 22-31 years) with “substantial” histories of psychostimulant abuse were randomized to receive, at intervals of at least 3 days, bupropion (100 mg, 200 mg, and 400 mg); d-amphetamine (15 mg and 30 mg); and placebo (J. Clin. Psychiatry 1983;44:206-8).
Drugs were administered at 8:00 a.m., with physiologic measures taken a half hour before administration and then hourly post dose. Bupropion had no measurable effect (relative to placebo) on blood pressure, pulse rate, respiratory rate, temperature, pupil size, appetite, caloric intake, or sleep. On self-rating scales, bupropion was perceived as an active drug only as often as placebo. The investigators concluded, “It is unlikely that bupropion will give rise to [amphetaminelike] patterns of abuse among normals or among those predisposed to psychostimulant abuse.” (The study came from the Baylor College of Medicine, the Houston Veterans Administration Medical Center, and the Burroughs Wellcome Research Laboratories.)
A double-blind, placebo-controlled, crossover study conducted at the Medical University of Innsbruck (Austria) examined the abuse liability of bupropion using caffeine as a positive control (Pharmacology 2004;70:206-15).
In all, 60 male smokers, aged 18-65 years, were enrolled; 50 completed the trial. The subjects were given two doses, 6 hours apart, of placebo, caffeine (178 mg), or bupropion slow-release (Zyban, 150 mg). They completed standardized telephone questionnaires at hourly intervals. Of the 50 subjects, 50% were able to report “any effect” to caffeine or bupropion. In those who reported “any effect” to caffeine, bupropion was reported as having essentially no effect. Subjects who reported effects from bupropion reported “much more intense effects” after bupropion than caffeine. The authors concluded that bupropion might be of some abuse liability.
The authors of this study cited another study, not picked up by our search, which was in part sponsored by a pharmaceutical company. That study compared bupropion with dexamphetamine and showed essentially no abuse liability of bupropion (Br. J. Clin. Pharmacol. 1979;7:469-78).
Investigators at the University of Chicago conducted a double-blind, placebo-controlled crossover study examining the effects of d-amphetamine and bupropion on cigarette smoking (Psychopharmacology 2001;157:243-53). In this study, 17 subjects, aged 19-54 years, received d-amphetamine (10 mg and 20 mg); bupropion (150 mg and 300 mg); and placebo. Subjective, physiologic, and behavioral effects were monitored, and amphetamine and bupropion increased self-reports of arousal, mood, and euphoria.
The Conclusion
The two university sponsored studies found an abuse liability of bupropion, and the two studies that were partly sponsored by pharmaceutical companies found no abuse liability. Our experience suggests that ingenious and determined patients have found ways, overlooked by published studies, to bypass bupropion’s first-pass metabolism and achieve highs similar to amphetamine.

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During the 7-week treatment phase, conducted Sept. 1, 1998, to March 31, 2001, subjects on bupropion had non-significant increased quit rates, compared with subjects on placebo (64% vs. 57%, respectively). Bupropion users continued to have the edge over placebo users at 3 months of follow-up (57% vs. 47%), although the difference also failed to reach statistical significance (Arch. Intern. Med. 164[16]:1797-803, 2004).
But at 6 and 12 months of follow-up, self-reported quit rates were nearly identical in both groups (about 40% at 6 months vs. about 32% at 12 months).
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COPYRIGHT 2008 Gale, Cengage Learning

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Bupropion and schizophreniaBupropion for smokersAbuse of bupropionBupropion Benefits Smoking CessationBupropion Or Patch For Smoking Cessation?

The 300 patients who were randomized to treatment with bupropion SR had a cessation rate of 36% at the end of treatment (week 7), which was significantly higher than the 19% rate in the 300 patients in the placebo group. Patients who were lost to follow-up were assumed to be smokers (JAMA 288[4]:468-74, 2002).
The patients in the bupropion SR group were significantly more likely to be continuously abstinent at weeks 1, 3, 6, and 26 than were those on placebo. The abstinence rate at 26 weeks was 21% with bupropion SR and 14% with placebo. Previous studies of bupropion SR in mostly white, middle-class individuals have found abstinence rates of 27%-35%. After adjustment for age differences, bupropion SR was associated with a 19% increase in the odds of quitting, compared with placebo.
Besides African Americans, “smoking cessation treatments that address the cultural needs and perspectives of Asian, Hispanic, Native American, and Pacific Islander populations are likely to be more effective than treatments that do not address cultural issues,” Dr. Neal L. Benowitz of the University of California, San Francisco, said in an editorial (JAMA 288[4]:49799, 2002).
The patients who received bupropion SR had significantly lower average weight over time than the patients who received placebo, but the patients who were continuously abstinent for 6 weeks had a significantly higher average weight over time than those who were not continuously abstinent for 6 weeks. A relationship between continuous abstinence and weight gain was independent of the use of the drug.
Dr. Ahluwalia and Dr. Benowitz have served as consultants to GlaxoSmithKline, Research Triangle Park, N.C., the manufacturer of bupropion SR.
COPYRIGHT 2002 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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Bupropion and schizophreniaBupropion for smokersAbuse of bupropionBupropion Benefits Smoking CessationBupropion Or Patch For Smoking Cessation?

While all patients had depressive symptoms–defined as a score of 10-30 on the Beck Depression Inventory–the study focused on 92 patients reporting a past history of major depression. Of these patients, 50 were in the bupropion SR group and 42 were in the placebo group. Of those in the bupropion group, 52% lost at least 5% of their body weight during the 26-week study, compared with 15% of the placebo group. “The changes in weight were significant for the overall population as well.”
But bupropion was effective in reducing depression symptoms only in patients with a history of major depression. Among the 92 patients with major depression, 52% of those taking bupropion SR achieved a depression index score reduction of 50%, compared with 28% of those taking a placebo. In contrast, scores for the overall study population did not change significantly.
COPYRIGHT 2003 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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Doug Herman, Vice-President and General Manager of BPC, said that Wellbutrin(R) XL is an effective first-line treatment for depression with a low incidence of side effects of greatest concern to patients.
“The favorable side-effect profile of Wellbutrin(R) XL is due to its unique dual-mode of action on norepinephrine and dopamine,” Mr. Herman said. “As the only first-line anti-depressant that does not affect serotonin, Wellbutrin(R) XL has a low risk of sexual dysfunction, weight gain and somnolence.”
Wellbutrin(R) XL is efficacious in the treatment of depression in adults, and is among the agents recommended for the first-line treatment of major depressive disorder. As a result of the unique dual-mode of action of bupropion (norepinephrine and dopamine), Wellbutrin(R) XL is typically not associated with those adverse effects common to agents that affect serotonin, such as sexual dysfunction, weight gain and somnolence.
Since it was launched in the United States in September 2003 by Biovail’s marketing partner GlaxoSmithKline, Wellbutrin(R) XL has captured 7.4% of the anti-depressant market in the United States. For the month ended February 28, 2006, Wellbutrin(R) XL captured 57.9% of new prescriptions written for the Wellbutrin(R) brand, including generics.
Canadian Depression Market
Wellbutrin(R) XL will participate in the C$770-million depression market in Canada. For the 12-month period ended December 31, 2005, bupropion SR prescriptions grew at more than twice the rate of the overall market.
About Depression
Depression affects an estimated 5%, or 1.45 million Canadians at any given time. A recent study conducted by Health Canada suggests that depression and distress cost Canadians at least $14.4 billion per year in treatment, medication, lost productivity and premature death. Depression is the second-leading cause of long-term disability among workers.
About Wellbutrin(R) XL
Wellbutrin(R) XL is the first and only once-daily norepinephrine dopamine reuptake inhibitor for the treatment of depression in adults. The active ingredient in Wellbutrin(R) XL, bupropion, acts upon norepinephrine and dopamine, two chemicals in the brain believed to help regulate different aspects of mood, cognition, and behavior. Imbalances in these brain chemicals may be associated with depressed mood and other symptoms of depression. Bupropion has no clinically significant impact on serotonin.
Wellbutrin(R), Wellbutrin(R) SR, and Wellbutrin(R) XL are trademarks of The GlaxoSmithKline Group of Companies, and are used by Biovail under license.
“Safe Harbor” Statement Under the Private Securities Litigation Reform Act of 1995
To the extent any statements made in this press release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and within the meaning of the “safe harbor” provisions of applicable Canadian securities legislation. These forward-looking statements relate to, among other things, our objectives, goals, strategies, intentions, plans estimates and outlook, and can generally be identified by the use of words such as “believe”, “anticipate”, “expect”, “intend”, “plan”, “will”, “may” and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.
Although Biovail believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, regulatory matters including compliance with pharmaceutical regulations, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, consolidated tax-rate assumptions, fluctuations in operating results and other risks detailed from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (”SEC”), the Ontario Securities Commission (”OSC”), and other securities regulatory authorities in Canada. Additional information about these factors and about the material factors or assumptions underlying any such forward-looking statements may be found in our current Annual Report on Form 20-F, and in particular under the heading “Risk Factors” under Item 3, Sub-Part D. Biovail cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on our forward-looking statements to make decisions with respect to the Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. We undertake no obligation to update or revise any forward-looking statement.

What is this drug, you ask? For its application as a smoking cessation aid, it is being sold under the name Zyban (the active ingredient is bupropion hydrochloride). The same drug has been sold as an antidepressant under the name Wellbutrin for quite some time now. Zyban is being promoted as the first non-nicotine drug on the market to treat addiction to nicotine.

Zyban works by boosting the levels in the brain of dopamine and norepinephrine, which is the same effect that nicotine has upon the brain. It mimics the action of nicotine, which reduces cravings for cigarettes themselves.

Using this drug may give smokers the same sense of well being as does nicotine, while being able to wean themselves off of cigarettes. Many ex-smokers have had success with this method of reducing the cravings. However, these pills are far more effective when taken in conjunction with a stop smoking program and changing ones behavior.

Research has suggested that this non-nicotine pill is more effective in helping smokers to quit than the nicotine patch. The pill and patch used together is a very effective method for quitting cigarettes, but may increase blood pressure.

It is recommended that Zyban be taken twice daily, in the morning and evening. However, it takes about a week for levels of the drug to build up to sufficient strength in the body; for this reason, Zyban has to be started at least a week before actually quitting. Most who take the pill for smoking cessation set a date to quit within one and two weeks of beginning the medication, and stay on it for two to three months.

This non-nicotine pill is not an over the counter medication, and is available by prescription only. A doctor should be consulted first in any case, as Zyban is not for everyone. You should not take Zyban if you are:

* Pregnant or currently nursing.
* Someone who has a history of eating disorders (e.g. bulimia or anorexia nervosa.)
* Currently taking or have recently taken a MAO medication for depression.
* Already taking Wellbutrin, or other medicines containing bupropion hydrochloride.
* Epileptic, or suffering from any other seizure disorder.

Caution: Seizures disorders are a special concern. Bupropion is known to cause seizures in about 1 out of every 1,000 people taking the drug. More commonly reported side effects include dry mouth and insomnia.

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Eon Labs is a generic pharmaceutical company specializing in developing, licensing, manufacturing, selling and distributing a broad range of prescription pharmaceutical products. For press releases and other company information, visit the Eon Labs, Inc. website at www.eonlabs.com.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This release contains statements that are forward-looking in nature which express the beliefs and expectations of management. Such statements are based on current plans, estimates and expectations and involve a number of known and unknown risks, uncertainties and other factors that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. These factors and additional information are discussed in the Company’s filings with the Securities and Exchange Commission and statements in this release should be evaluated in light of these important factors. Although we believe that these statements are based upon reasonable assumptions, we cannot guarantee future results. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
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