Vivitrol News and Research

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Vivitrol is a drug that blocks the action of opiates (drugs used to treat pain). It may be used in the treatment of intravenous opiate addiction or alcohol dependence. Vivitrol is also being studied in the treatment of breast cancer. It may block the effects of the hormone estrogen, which causes some breast cancer cells to grow, or block the blood flow to tumors. It is a type of opiate antagonist. Also called naltrexone, naltrexone hydrochloride, and ReVia.

Alkermes's ALKS 33 drug candidate offers potential treatment for multiple disease indications

Alkermes, Inc. today announced the presentation of promising preclinical results for its proprietary opioid modulator, ALKS 33, showing the drug candidate's potential in multiple disease indications.

17 Nov 2010

Positive results from Alkermes combination Phase 1 study of ALKS 33 and buprenorphine for cocaine addiction

Alkermes, Inc. today announced positive topline results from a phase 1 clinical study of an investigational combination of ALKS 33, one of Alkermes' proprietary candidates, and buprenorphine, an existing medication for the treatment of opioid addiction, for the treatment of cocaine addiction.

25 Oct 2010

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

The Partnership at Drugfree.org issues statement on FDA approval of VIVITROL for opioid dependence

The U.S. Food and Drug Administration's approval of Alkermes' opioid dependence medication (VIVITROL) for the prevention of relapse to opioid dependence following opioid detoxification is positive news for families of young adults and all those who are struggling to overcome opioid addiction. Addiction, a disease of the human brain, is a chronic illness while opioid dependence is frequently characterized by relapse.

13 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

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

Alkermes reports $42.3 million revenue for first-quarter fiscal 2011

Alkermes, Inc. today reported financial results for its first quarter of fiscal 2011, which ended on June 30, 2010.

7 Aug 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 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

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

Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC

Alkermes, Inc. today announced the initiation of a multidose phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled, repeat-dose study will assess the safety, tolerability and pharmacokinetics of daily oral administration of two dose levels of ALKS 37 for a seven day period in approximately 24 healthy volunteers.

17 Mar 2010

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

Alkermes, Inc. today announced positive topline data from a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC).

16 Feb 2010

Alkermes develops proprietary LinkeRx technology platform to create injectable antipsychotics

Alkermes, Inc. today announced that it has developed a novel, proprietary LinkeRx™ technology platform to enable the creation of injectable extended-release versions of antipsychotics and other central nervous system (CNS) therapies.

4 Feb 2010

Alkermes licenses Medifusion technology to develop TNF receptor-Fc fusion protein

Alkermes, Inc. and Acceleron Pharma, Inc. today announced that Alkermes has licensed a proprietary long-acting Fc fusion technology platform, called the Medifusion™ technology, which is designed to extend the circulating half-life of proteins and peptides.

4 Dec 2009

Alkermes commences phase 2 study of ALKS 33 in patients with alcohol dependence

Alkermes, Inc. today announced the initiation of a phase 2 clinical study of ALKS 33, an investigational oral opioid modulator for the potential treatment of alcohol dependence and other central nervous system disorders. The study will assess the safety and efficacy of multiple doses of ALKS 33 in patients with alcohol dependence and is designed to further define the clinical profile of ALKS 33.

17 Nov 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

Alkermes commences ALKS 37 phase 1 clinical trial for the treatment of opioid-induced constipation

Alkermes, Inc. today announced the initiation of a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the opioid agonist effects on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetic effects of a single oral administration of five doses of ALKS 37 in approximately 40 healthy volunteers.

27 Oct 2009

Positive results from Alkermes' ALKS 33 clinical trials announced

Alkermes, Inc. today announced positive topline data from two clinical trials of ALKS 33, an investigational oral opioid modulator for the treatment of addiction and other central nervous system disorders. Data from the studies, ALK33-003 and ALK33-004, showed that ALKS 33 was generally well tolerated and successfully blocked the effects of an opioid, with a duration of action that supports once daily dosing.

13 Oct 2009

Vivitrol News and Research

Alkermes's ALKS 33 drug candidate offers potential treatment for multiple disease indications

Positive results from Alkermes combination Phase 1 study of ALKS 33 and buprenorphine for cocaine addiction

PMAI offers new addiction treatment options for opioid dependence

The Partnership at Drugfree.org issues statement on FDA approval of VIVITROL for opioid dependence

Alkermes' VIVITROL medication for treatment of opioid dependence

FDA approves Vivitrol for treatment of opioid-dependent patients

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

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

Alkermes reports $42.3 million revenue for first-quarter fiscal 2011

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

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

Alkermes submits VIVITROL sNDA for opioid dependence

Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

Alkermes develops proprietary LinkeRx technology platform to create injectable antipsychotics

Alkermes licenses Medifusion technology to develop TNF receptor-Fc fusion protein

Alkermes commences phase 2 study of ALKS 33 in patients with alcohol dependence

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

Alkermes commences ALKS 37 phase 1 clinical trial for the treatment of opioid-induced constipation

Positive results from Alkermes' ALKS 33 clinical trials announced

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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