Opioid Drug News and Research

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QRxPharma granted FDA pre-NDA meeting, further phase II data released

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the granting of a pre-New Drug Application (NDA) meeting with the United States Food and Drug Administration (FDA) and successful completion of its third pivotal Phase 3 registration trial (study 009) for immediate-release MoxDuo.

20 Feb 2011

FDA calls for cuts in Acetaminophen in painkillers

The US FDA has asked for a limit on the amount of acetaminophen in prescription pain medicines in an effort to reduce the risk of liver damage. The announcement yesterday asked manufacturers to limit combination drugs such as the opioids Percocet and Vicodin to 325 milligrams of acetaminophen per pill and asked them to carry a “black box” warning about potential liver failure. At present these combinations carry up to 750 milligrams of acetaminophen.

13 Jan 2011

NSAIDs raise risk of heart disease: Study

A new study published online in the British Medical Journal explores the relative safety of non-steroidal anti-inflammatory medications (NSAIDs), commonly used to treat joint and muscle aches and pain and concludes that NSAIDs significantly increase the risk of cardiovascular events in patients who take them regularly.

12 Jan 2011

New cough suppressant from cocoa

People suffering from persistent cough may soon have a remedy that is derived from cocoa. At present researchers are carrying out the final stages of clinical trials of a drug that contains theobromine, an ingredient found in chocolate and cocoa. The drug could be in the market in another two years.

22 Dec 2010

New study finds no decrease in patient harm at hospitals

Despite concerted efforts, no decreases in patient harm were detected at 10 randomly selected North Carolina hospitals between 2002 and 2007, according to a new study from the Stanford University School of Medicine, Harvard Medical School and the Institute for Healthcare Improvement.

25 Nov 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

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

Etoricoxib better than opioid drug tramadol for postoperative pain: Study

For patients with moderate pain after foot surgery, the cyclo-oxygenase 2 (COX-2) inhibitor drug etoricoxib provides better pain relief with fewer side effects than the opioid drug tramadol, concludes a study in the August issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

3 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

First-quarter fiscal 2010 results announced by China Aoxing Pharmaceutical

China Aoxing Pharmaceutical Company, Inc., a China-based pharmaceutical company specializing in research, development, manufacturing and distribution of narcotic and pain-management products, today announced financial and operational results for the three month ended September 30, 2009, or the first quarter of fiscal year 2010.

24 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

China SFDA approves clinical trial of China Aoxing's abuse resistant opioid drug

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a China-based pharmaceutical company specializing in research, development, manufacturing and distribution of narcotic and pain-management products, today announced that its Clinical Trial Application ("CTA") for Tilidine/Naloxone Capsules, an opioid drug with abuse resistance property, was officially approved by the China State Food and Drug Administration ("SFDA").

17 Sep 2009

Adding a drug called neostigmine to epidural analgesia reduces dose needed during labor

Adding a drug called neostigmine to epidural analgesia during labor can reduce the amount of anesthetic drug required, while avoiding potential complications caused by morphine-like "opioid" drugs, according to a study in the August issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

27 Jul 2009

FDA approves Onsolis pain reliever for cancer patients

The U.S. Food and Drug Administration today approved Onsolis, medication intended for certain patients with cancer to help manage breakthrough pain – severe flares of pain that break through regular pain medication.

16 Jul 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

Local anaesthetic reduces need for painkillers post-Caesarean section

Giving a local anaesthetic during a Caesarean section helps manage pain after the operation and can reduce consumption of painkillers, according to Cochrane Researchers. The researchers recommend local anaesthetics as part of integrated pain management strategies for Caesarean section operations, provided that consideration is given to the cost.

7 Jul 2009