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FDA extends Exalgo NDA review by three months

20. November 2009 08:11
CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™ (hydromorphone HCl) extended-release tablets by three months. [More]

Posted in: Business / Finance | Pharmaceutical News

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Recent data from CNSBio's Phase IIa CNSB015 trial to be presented at the Neuropathic Pain conference

18. November 2009 08:24
CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. [More]

Posted in: Drug Trial News | Medical Condition News

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Johns Hopkins program reduces need for airway surgery in hard-to-intubate patients

18. November 2009 06:45
Be prepared, that old Boy Scout motto, is being applied with great success to operating room patients whose anatomy may make it difficult for physicians to help them breathe during surgery, Johns Hopkins researchers report in a new study. [More]

Posted in: Medical Procedure News | Healthcare News

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FDA approves Qutenza, a pain relief product for patients who suffer from PHN

18. November 2009 00:38
The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles. [More]

Posted in: Pharmaceutical News

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YM BioSciences presents preclinical results of its small molecule VDA at the AACR-NCI-EORTC conference

17. November 2009 07:55
YM BioSciences Inc., a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, announced that preclinical results for CYT997 were presented today in a poster by Cytopia Limited at the 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference in Boston, Massachusetts. [More]

FDA provides feedback on the pending NDA for EXALGO tablets

17. November 2009 03:33
CombinatoRx, Incorporated and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate EXALGOTM (hydromorphone HCl extended release) tablets, seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with staff from the United States Food and Drug Administration (FDA). [More]

Posted in: Pharmaceutical News

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Neuromed discusses Exalgo NDA application with the FDA

16. November 2009 09:27
Covidien today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate ExalgoTM (hydromorphone HCl extended release) tablets with staff from the United States Food and Drug Administration (FDA). Mallinckrodt Inc., a Covidien company, obtained the commercial rights to Exalgo in the United States from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd., in June 2009. [More]

Posted in: Pharmaceutical News

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

16. November 2009 08:49
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). [More]

Abbott signs agreement to acquire global rights to PanGenetics BV's PG110

13. November 2009 03:12
Abbott announced today a definitive agreement to acquire the global rights to PanGenetics BV's PG110 fully humanized antibody to Nerve Growth Factor (NGF), expanding the company's pain care portfolio and leveraging its expertise in biologics. PG110 is a novel biologic in Phase I clinical trial development that targets NGF for the treatment of chronic pain. [More]

Financial results for third-quarter 2009 announced by Combinatorx

3. November 2009 08:47
CombinatoRx, Incorporated today reported financial results for the third quarter ended September 30, 2009. [More]

NIH awards $4 million research grant to AllTranz

3. November 2009 07:37
AllTranz, Inc., a specialty pharmaceutical company focused on developing drugs to treat a variety of neurologic and inflammatory disorders, today announced that it has been awarded a $4 million research grant from the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), to advance the company’s transdermal tetrahydrocannabinol (THC) patch for the treatment of marijuana dependence and withdrawal. [More]

Risk of postoperative visual loss is highest after heart surgery

3. November 2009 06:45
Imagine waking up after surgery to find out you have lost your sight—permanently. Although rare, postoperative visual loss is a well-recognized complication of anesthesia and surgery that is more common after certain types of procedures and in some groups of patients, according to a study in the November issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS). [More]

Posted in: Medical Condition News

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AcelRx Pharmaceuticals completes End-of-Phase 2 meeting with the FDA for its ARX-01drug/device

30. October 2009 07:42
AcelRx Pharmaceuticals, Inc. today announced that it has successfully completed an End-of-Phase 2 meeting with the FDA for ARX-01, a drug/device combination product based on the company's proprietary NanoTab(TM) dosage form, which enables delivery of sufentanil by the non-invasive oral transmucosal (sublingual) route. [More]

Posted in: Drug Trial News | Device / Technology News

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Hospira's patient-controlled analgesia infusion system celebrates 25 years of pain management

30. October 2009 07:20
Today Hospira, Inc. celebrates the 25th anniversary of its market-leading patient-controlled analgesia (PCA) infusion system. Introduced in 1984, Hospira's PCA was the first pump of its kind, revolutionizing pain management. It was a simple concept: patients know best when they are in pain, so allow them, within limits, to control their medication. [More]

Posted in: Device / Technology News

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New hope for chronic pain sufferers

30. October 2009 04:18
In an Anglo-Italian study, thirty healthy subjects were invited to look at either their own hand, the experimenter's hand, or an object, while their hand was subjected to laser-induced pain. [More]

Posted in: Medical Condition News

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