Product News and Clinical Trial Results
Risk of misuse, abuse, addiction and overdose for ACTIQ and FENTORA;
FDA-required restricted distribution program
Source: Cephalon, Inc.
Cephalon is informing healthcare professionals of the implementation of a restricted distribution program designed to help ensure appropriate patient selection and the safe use of ACTIQ C-II and FENTORA C-II. Because of the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors, ACTIQ and FENTORA are only available through the FDA-mandated ACTIQ and FENTORA Risk Evaluation and Mitigation Strategy. Beginning March 20th only prescribers, pharmacies, distributors, and patients enrolled in the program are able to prescribe, dispense, distribute, and receive ACTIQ or FENTORA in an outpatient setting.
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Bone-strengthening drug gives pain relief in prostate cancer bone metastases
September 25, 2011 Source: Medical News Today
Many prostate cancer patients develop bone metastases, and controlling the pain these cause can be difficult. Now the first large randomised Phase III trial of a bisphosphonate drug in these patients has shown that a single dose of the drug is as good for pain relief as single dose radiotherapy, the standard treatment for bone metastases.
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Results of a pivotal Phase 3 efficacy and safety study for Butrans® (Buprenorphine) Transdermal System CIII published in the Journal Of Pain
September 24, 2011 Source: Medical News Today
Butrans® (Buprenorphine) Transdermal System CIII 20 mcg/hour provided significantly lower "average pain over the last 24 hours" scores compared to Butrans 5 mcg/hour when used in opioid-experienced patients with moderate-to-severe chronic low back pain, according to a pivotal Phase 3 clinical study. Butrans is the first transdermal system approved in the United States that delivers continuous release of the active ingredient, buprenorphine, for seven days.
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Nektar presents positive data for novel opioid analgesic, NKTR-181, at the 2011 American Academy of Pain Management annual meeting
September 22, 2011 Source: Medical News Today
Nektar Therapeutics today announced that positive proof-of-concept data from its first Phase 1 clinical trial of NKTR. The data show that NKTR-181 produced a clear dose-dependent analgesic response in a cold pressor test and its molecule enters the brain slowly. With this reduced rate of entry into the CNS, NKTR-181 has the potential to greatly reduce the euphoria that drives opioid abuse liability and dependence.
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Chemotherapy-induced neuropathic pain: the pain of surviving cancer
September 16, 2011 Source: DARA BioSciences
The treatment of cancer often leads to additional pain syndromes such as chemotherapy-induced neuropathic pain. Recently, a study was conducted to determine safety and efficacy of KRN5500 as treatment for neuropathic pain in patients with advanced cancer and neuropathic pain. Results showed KRN5500 to be both statistically and clinically significant in alleviating neuropathic pain, reaching its primary end-point – reduction of pain from baseline.
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Medtronic model 8637 Synchromed II implantable infusion pump: class I recall - potential for reduced battery performance
September 12, 2011 Source: U.S. Food and Drug Administration
Medtronic notified healthcare professionals of a Class I recall of the SynchroMed II Infusion system. Analysis of the problem indicates it is related to the formation of a film within the pump battery that can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms. The recall includes the SynchroMed II Implantable Infusion Pump models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.
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