Opioid Dependence News and Research

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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

BioDelivery Sciences International announces filing of Annual Report with U.S. SEC

BioDelivery Sciences International, Inc. has filed its Annual Report with the U.S. Securities and Exchange Commission on Form 10-K for the fiscal year ended December 31, 2009. Such Form 10-K is available on the SEC’s website at www.sec.gov.

20 Mar 2010

BDSI provides update on product portfolio, key upcoming milestones

BioDelivery Sciences International, Inc. today provided a summary of its business overview webcast that was conducted on Thursday, February 25, 2010. Dr. Mark A. Sirgo, President and Chief Executive Officer, and Dr. Andrew L. Finn, Executive Vice President of Product Development, provided an update on the product portfolio, including development plans, anticipated timelines, and key upcoming milestones.

28 Feb 2010

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

NIH awards Titan $7.6M grant for Probuphine clinical development

Titan Pharmaceuticals, Inc today announced that the National Institutes of Health (NIH) has awarded a Research and Research Infrastructure Grand Opportunities grant to the company through the American Reinvestment and Recovery Act of 2009 (ARRA). The two year grant for Probuphine clinical development is expected to provide approximately $7.6 million, with the first year award of approximately $ 5.6 million now made available to Titan by the NIH.

3 Oct 2009

Review of addiction to prescription painkillers

Chemical dependency and recovery in patients and physicians are closely examined in a series of articles and editorials in the July 2009 issue of Mayo Clinic Proceedings. The subject is especially timely. As the immense challenges, including potential tragedies, of prescription chemical addiction and abuse are being discussed, these articles offer crucial overview, direction and optimism.

7 Jul 2009

Double the number of Australians now being treated for heroin addiction

The latest report from the Australian Institute of Health and Welfare (AIHW) shows in the last decade the number of Australians being treated for heroin, or other opioid, addiction has almost doubled.

22 May 2009

Ondansetron shown to be a viable treatment option for opioid addiction

Scientists at Stanford University School of Medicine have discovered that a commonly available non-addictive drug can prevent symptoms of withdrawal from opioids with little likelihood of serious side effects.

18 Feb 2009

Extended suboxone treatment substantially improves outcomes for opioid-addicted young adults

In the first clinical trial of a medication that was used for an extended time to treat opioid addiction in young adults, participants who received counseling and Suboxone (buprenorphine-naloxone) for 12 weeks had substantially better outcomes than those who received the standard treatment of short-term detoxification and counseling.

4 Nov 2008

Quitting heroin under anesthesia is dangerous and ineffective

According to a new study, having a general anesthesia is not an effective way for heroin users to avoid the painful, drawn-out process of breaking their habit and can be dangerous.

24 Aug 2005

Use of general anesthesia for heroin detoxification offers no benefit when compared to two other methods

The use of general anesthesia for heroin detoxification offers no benefit when compared to two other methods, and is associated with several potentially life-threatening adverse events, according to an article in the August 24/31 issue of JAMA: The Journal of the American Medical Association.

23 Aug 2005

Biotoxin from puffer fish may provide treatment for opioid withdrawal

On November 10, 2004 investigators involved in a Phase IIa clinical trial of the novel biotoxin Tetrodotoxin (TTX) for the treatment of opioid withdrawal enrolled their first participants.

18 Nov 2004