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Combined alcohol dependency treatments reduce social costs of health care: Study

Combining medications and behavioral interventions for treating alcohol-dependent patients reduces social costs of health care, arrests and motor vehicle accidents, according to a new study by researchers at RTI International, University of Wisconsin-Milwaukee, University of North Carolina at Chapel Hill, University of Pennsylvania and Yale University.

3 Jun 2010

FDA accepts Orexigen's Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity.

2 Jun 2010

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that the supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and Drug Administration (FDA).

25 May 2010

Stinging FDA review for Acurox – the implications

The US FDA’s advisory panel’s decision to recommend against approval of Acura Pharmaceuticals/King Pharmaceuticals’ Acurox (oxycodone plus niacin) was based upon the view that data were lacking that niacin-induced flushing could potentially reduce misuse of Acurox with single-ingredient oxycodone. The panel also contended that clinical studies were not conducted in populations that might be likely to benefit from the drug’s purported abuse-deterrent properties, such as those with chronic pain and adolescents who are experimenting with drug use.

27 Apr 2010

Alkermes submits VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that it has submitted a supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) to the U.S. Food and Drug Administration (FDA) for approval as a treatment for opioid dependence. The company requested a priority review for its sNDA and if granted by the FDA, it would mean a six month review timeline.

13 Apr 2010

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc. announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.

1 Apr 2010

Two EMBEDA video news releases misleading, warns FDA DDMAC

On October 8, 2009, King Pharmaceuticals, Inc. received a Warning Letter from the Division of Drug Marketing, Advertising, and Communications (DDMAC) at the Food and Drug Administration regarding two video news releases - EMBEDA Media backgrounder, and EMBEDA Visual Media Technology, for EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use C-II.

27 Mar 2010

Patheon's first-quarter fiscal 2010 total revenues up 5.2%

Patheon a global provider of drug development and manufacturing services to the international pharmaceutical industry today announced results for its first quarter ended January 31, 2010. All amounts are in U.S. dollars unless otherwise indicated.

15 Mar 2010

Orexigen Therapeutics, Patheon sign long-term agreement for commercial manufacturing of Contrave

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, and Patheon Inc., a global provider of drug development and manufacturing services, announced today a long-term agreement for commercial manufacturing of Contrave® (naltrexone HCL sustained release (SR)/bupropion HCL SR) as well as development of future formulations of Orexigen products.

15 Mar 2010

2010 European LDN Conference: LDN can be used as effective treatment for people with MS

People with MS (Multiple Sclerosis) and others suffering with a range of often debilitating inflammatory conditions such as Chronic Fatigue Syndrome and Fibromyalgia, will take heart from advances in treatment for their conditions, and will follow events at The 2nd European LDN Conference with interest.

10 Mar 2010

Researchers identify individualized treatments for pathological gambling

Pathological gambling can be successfully treated with medications that decrease urges and increase inhibitions, according to researchers at the annual meeting of the American College of Neuropsychopharmacology (ACNP).

10 Dec 2009

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

Alkermes, Inc. today announced positive preliminary results from a phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens (p<0.0002).

16 Nov 2009

Grant awarded for research into a new treatment for methamphetamine addiction

Dr. Keith Flower - a research physician at the Addiction Pharmacology & Research Laboratory in San Francisco, CA - has been awarded a grant to investigate a new medication treatment for methamphetamine addiction. This grant has been awarded to California Pacific Medical Center's Research Institute through President Obama's AMERICAN RECOVERY AND REINVESTMENT ACT OF 2009.

6 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

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

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

King Pharmaceuticals achieves milestone: Announces commercial availability of EMBEDA

King Pharmaceuticals(R), Inc. (NYSE: KG) today announced a true milestone as it marks the first commercial availability for EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

21 Sep 2009

New research on post-traumatic stress disorder to be presented at MHRF

New research on post-traumatic stress disorder (PTSD) is being presented this week at the Military Health Research Forum (MHRF), a scientific conference hosted by the Department of Defense (DOD) Congressionally Directed Medical Research Programs (CDMRP). Depending on the conflict in which they served, 10 to 30 percent of soldiers who have spent time in war zones experience the debilitating and life-altering symptoms of post-traumatic stress disorder (PTSD).

2 Sep 2009

Naltrexone appears to relieve fibromyalgia pain

For Tara Campbell, the onset of her fibromyalgia began slowly with repeated sore throats, fevers and fatigue.

20 Apr 2009