Naltrexone News and Research

RSS

PMAI offers new addiction treatment options for opioid dependence

Punyamurtula S. Kishore MD, MPH, FASAM, of Preventive Medicine Associates, Inc. (PMAI), the largest outpatient substance dependence provider in Massachusetts, announced today his 37 clinical locations will be offering new addiction treatment options through the use of VIVITROL (naltrexone for extended-release injectable suspension), which was approved on Tuesday, October 12, 2010 by the U.S. Food and Drug Administration (FDA) for the prevention of relapse to opioid dependence.

21 Oct 2010

Alkermes' VIVITROL medication for treatment of opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VIVITROL(naltrexone for extended-release injectable suspension) for the prevention of relapse to opioid dependence, following opioid detoxification.

13 Oct 2010

FDA approves Vivitrol for treatment of opioid-dependent patients

The U.S. Food and Drug Administration today approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.

13 Oct 2010

Elite Pharmaceuticals signs agreements with Precision Dose for four generic products

Elite Pharmaceuticals, Inc. announced today the signing of a license agreement and a manufacturing and supply agreement with Precision Dose, Inc. which has a wholly owned subsidiary, TAGI Pharma, Inc. which will distribute the products covered by the agreement. Pursuant to the License Agreement, TAGI Pharma will market and sell four Elite generic products in the United States, Puerto Rico and Canada.

17 Sep 2010

Alcohol addiction drug may help opioid addicts: FDA panel considers reports

A U.S. Food and Drugs Administration (FDA) panel, this Thursday agreed that a new drug Vivitrol helps alcoholics and opioid addicts kick the habit. The panel voted 11 to 2 that there was sufficient evidence from a single clinical trial that Vivitrol is effective when it comes to helping people addicted to painkillers.

17 Sep 2010

FDA Advisory Committee recommends approval of Alkermes' VIVITROL for opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.

17 Sep 2010

Orexigen and Takeda partner to develop, commercialize Contrave in US, Canada and Mexico

Orexigen® Therapeutics, Inc. and Takeda Pharmaceutical Company Limited, today announced that they have entered into an exclusive partnership to develop and commercialize Contrave® (naltrexone SR/bupropion SR), Orexigen's investigational drug for the treatment of obesity, in the United States, Canada and Mexico.

2 Sep 2010

Contrave added to diet and exercise regimen can induce significant weight loss

Orexigen Therapeutics, Inc. announced the online publication of results from its COR-BMOD trial of Contrave (naltrexone SR/bupropion SR) in the journal Obesity. The COR-BMOD trial evaluated intensive behavior modification plus Contrave32 (32mg naltrexone sustained release (SR)/360mg bupropion SR) compared to BMOD plus placebo, in 793 overweight or obese patients.

4 Aug 2010

Orexigen's Contrave COR-I trial results published online in journal Lancet

Orexigen® Therapeutics, Inc. announced that results from its COR-I trial of Contrave® were published online today in the journal Lancet. COR-I was the largest of the four, 56-week, Phase 3 trials supporting the New Drug Application for Contrave, currently under review by the U.S. Food and Drug Administration. Results show that patients taking Contrave were two to three times more likely to lose at least 5% or 10% of their body weight compared to those taking placebo, on both an intent-to-treat (ITT) and completers basis.

30 Jul 2010

Orexigen Therapeutics announces data from CORDiabetes trial for Contrave

Orexigen Therapeutics, Inc. today announced data from the CORDiabetes trial for Contrave (naltrexone sustained release (SR)/bupropion SR) showing that after 56 weeks of treatment, overweight or obese patients with type 2 diabetes lost significantly more weight and achieved greater improvement in glycemic control than those treated with placebo.

28 Jun 2010

FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled a Division of Metabolic and Endocrine Drug Products Advisory Committee meeting on December 7, 2010 to review the Company's New Drug Application (NDA) for Contrave® (naltrexone sustained release (SR)/bupropion SR) for the treatment of obesity.

24 Jun 2010

Alkermes receives tentative schedule notification for FDA advisory committee meeting on VIVITROL sNDA

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company's supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence.

18 Jun 2010

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 for the review of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application (NDA).

17 Jun 2010

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