Bupropion News and Research

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Watson Laboratories files ANDA for generic Aplenzin ER in treatment of major depressive disorder

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.- Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 174 mg and 348 mg strength bupropion hydrobromide tablets prior to the expiration of patents owned by Biovail. Watson's 174 mg and 348 mg strength bupropion hydrobromide tablet products are generic versions of Biovail's Aplenzin™ ER, which is indicated for major depressive disorder.

23 Feb 2010

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

Biovail Corporation today commented on a proposed clinical trial recently announced by Teva Pharmaceutical Industries Ltd. According to Teva, the trial is intended to address reports of inefficacy and adverse events by consumers who switched from Wellbutrin XL® 300 mg, Biovail’s FDA-approved brand of the antidepressant, bupropion hydrochloride, to Budeprion XL, Teva’s generic formulation of the drug. The trial was described in a Dow Jones Newswire article dated December 2, 2009.

22 Jan 2010

USPTO issues Notice of Allowance for IntelGenx's bupropion patent

IntelGenx Corp. ("IntelGenx") today announced that the U.S. Patent and Trademark Office ("USPTO") has issued a formal Notice of Allowance for a key patent application protecting IntelGenx's CPI-300, a novel, high strength formulation of bupropion hydrochloride ("HCl"), the active ingredient in Wellbutrin XL(R).

21 Jan 2010

IQWiG calls for mandatory registration and publication of all clinical trial results

Today the Institute for Quality and Efficiency in Health Care (IQWiG) is calling for registration and publication of the results of all clinical trials to be made obligatory.

25 Nov 2009

Reboxetine drug does not alleviate depression, says new study

There is no scientific proof that people suffering from depression can benefit from taking reboxetine. However, clinical trials do provide proof of benefit of bupropion XL and mirtazapine: both agents can alleviate symptoms. This is the conclusion of the final report of the Institute for Quality and Efficiency in Health Care (IQWiG) published on 24 November 2009.

24 Nov 2009

States are not taking enough efforts to help smokers quit: American Lung Association

As the debate over health care reform dominates the media and political arena, a new American Lung Association report finds that states aren't doing enough to help smokers quit - and policymakers must fix this in the health care reform process.

11 Nov 2009

Want to quit smoking? Try a nicotine patch plus a nicotine lozenge

In a comparison of five different smoking cessation medications, a nicotine patch plus a nicotine lozenge appears most effective at helping smokers quit, according to a report in the November issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

3 Nov 2009

Monash University physiologist honored with Life Scientist of the Year award

A Monash University physiologist, whose research into weight management, obesity and diabetes has led to significant medical breakthroughs and drug design, has been awarded one of the nation's top research honours.

30 Oct 2009

Development of VLN cigarettes for use in smoking cessation continues: 22nd Century

22nd Century Limited, LLC is pleased to announce that it is continuing development of a very low nicotine cigarette for use in smoking cessation. Clinical trial results demonstrate that these cigarettes, also referred to as ‘nicotine-free’ and ‘denicotinized,’ may be more effective for quitting than FDA-approved therapies.

28 Oct 2009

Orexigen Therapeutics presents phase 3 trial results of Contrave for treating obesity

Orexigen® Therapeutics, Inc. today announced results from new intent to treat (ITT) analyses from the COR-I and COR-II Phase 3 trials of Contrave® (naltrexone SR/bupropion SR), the first of two late stage Orexigen candidates for the treatment of obesity. These data expand on top-line results announced in July and complement findings from a panel discussion on Saturday where the Company presented data on Contrave patients who completed 56 weeks of therapy.

28 Oct 2009

New systematic study for managing treatment-resistant bipolar depression

Depression in bipolar illness is often difficult to treat and life-threating. Frequently it fails to respond to standard treatments. In the current issue of Psychotherapy and Psychosomatics a new drug combination is suggested.

27 Oct 2009

Orexigen Therapeutics announces new data from COR-I, COR-II and COR-Diabetes trials for Contrave

Orexigen® ( )Therapeutics, Inc today announced new data from the COR-I, COR-II and COR-Diabetes trials for Contrave® (bupropion SR/ naltrexone SR) to expand on top-line results announced in July. Contrave is the first of the Company's two late stage candidates for the treatment of obesity.

26 Oct 2009

Orexigen's Empatic Phase 2b results demonstrate weight loss

Orexigen Therapeutics, Inc. today announced that its 24-week, Phase 2b trial for Empatic(TM) (bupropion SR/zonisamide SR), the Company's second late stage investigational combination drug for the treatment of obesity, met its primary efficacy endpoint by demonstrating statistically significantly greater weight loss for both Empatic doses compared to monotherapies and placebo.

1 Oct 2009

Results from the BRITE-MD trials published in Psychiatry Research: Aspect Medical Systems

Aspect Medical Systems, Inc. (NASDAQ: ASPM) today announced that two companion articles highlighting results from the BRITE-MD (Biomarkers for Rapid Identification of Treatment Effectiveness trial in Major Depression) were published in the September issue of the journal Psychiatry Research.

11 Sep 2009

Biomarkers for rapid identification of treatment effectiveness in major depression

Now, based on the final results of a nationwide study led by UCLA, clinicians may be able to accurately predict within a week whether a particular drug will be effective by using a non-invasive test that takes less than 15 minutes to administer. The test will allow physicians to quickly switch patients to a more effective treatment, if necessary.

11 Sep 2009

Venlafaxine alleviates depressive symptoms

The Institute for Quality and Efficiency in Health Care (IQWiG) was commissioned by the Federal Joint Committee (G-BA) to investigate whether patients with depression benefit from taking drugs belonging to the selective serotonin and norepinephrine reuptake inhibitor (SNRI) drug class.

25 Aug 2009

Biovail's patent infringement lawsuit against Cary Pharma may affect IntelGenx revenues

IntelGenx Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) ("IntelGenx") previously announced that the New Drug Application (NDA) filing for the antidepressant CPI-300, which it developed with Cary Pharmaceuticals ("Cary Pharma") had been accepted by the U.S. Food and Drug Administration (FDA) for standard review. CPI-300 is a novel, high strength of Bupropion HCl, the active ingredient in Wellbutrin XL®.

24 Aug 2009

Chantix and Zyban to get boxed warnings on serious mental health events

The U.S. Food and Drug Administration has announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

1 Jul 2009

GSK to divest U.S. rights for Wellbutrin XL to Biovail

GlaxoSmithKline has announced that it has entered into an agreement to divest full commercial rights to Wellbutrin XL in the United States to Biovail International Laboratories SRL, a subsidiary of Biovail Corporation, for $510 million (euro 340 million). The agreement is subject to Hart-Scott-Rodino regulatory clearance in the United States.

6 May 2009

New antidepressants might be no more effective than the best existing drugs

The reviews suggest that sertraline - sold under the brand name Zoloft since 1991- could be the best initial choice of antidepressant in people with acute major depression. The generic formulation produced the best balance of effectiveness, tolerability and purchase price, the authors say.

5 May 2009