“Unclear” whether opioids are effective at treating cancer pain

Source: www.eurekalert.org Author: Peer-reviewed publication, University of Warwick The world’s largest review on opioid medicines for cancer pain has found it is unclear whether some commonly used opioid medicines are better than a placebo and suggests that non-opioid medicines, including aspirin, may be as effective as opioids. Researchers examining the data on opioids for pain caused by cancer have found surprisingly large gaps in evidence regarding the true benefits of these medicines for cancer pain. The study challenges the commonly held view that opioids are the most powerful pain relievers. The study, led by The University of Sydney and including The University of Warwick highlights that there is no ‘one size fits all’ treatment approach for cancer pain, urging health professionals and patients to carefully weigh up the evidence when deciding on a suitable pain management plan. Opioid pain relievers are the most common treatment for cancer pain management. Many international guidelines including the World Health Organization, recommend opioid medications to manage background cancer pain (constant pain) and breakthrough cancer pain (temporary flare-ups of pain in addition to background pain). However, the study found very few trials have compared commonly used opioid medicines with placebo. This included morphine, oxycodone and methadone. The study did not find convincing evidence that morphine was better or safer than other opioid medicines for background cancer pain outside of end-of-life care. This is despite morphine being widely viewed as the ‘gold standard treatment’ for cancer care by physicians and recommended in many international clinical guidelines [...]

2023-12-19T12:32:24-07:00December, 2023|Oral Cancer News|

NYU Expert Says Cancer Pain Varies by Tumor Type

Source: www.onclive.com Author: Jane de Lartigue, PhD Brian L. Schmidt, DDS, MD, PhD, is a specialist in head and neck cancers whose research focus includes an exploration of the biological and molecular mechanisms of pain related to cancer and associated treatments. He is the director of the New York University (NYU) Oral Cancer Center and of the Bluestone Center for Clinical Research, and a professor of oral and maxillofacial surgery at the NYU School of Dentistry. In June 2016, the National Institutes of Health awarded Schmidt and colleagues a $1.2 million grant to study gene therapy for the treatment of patients with oral cancer pain. Schmidt talked to OncLive about the difficulties of studying cancer pain and developing new drugs. OncLive: How has our understanding of the mechanisms of cancer pain changed in the past decade? Schmidt: The field was developed probably in about 1999. That’s the first publication that I’m aware of that looked at mechanisms in terms of using preclinical models, and by that I mean animal models. Before that time we really had no understanding of basic mechanisms, so there’s been significant advancement over the last 10 years. Could you briefly describe our current understanding of how cancer pain develops? Let me tell you what it’s not, because I think that’s important. For many years, people were writing about it but we weren’t testing the possible mechanisms, and what people were writing turned out probably not to be true. It was initially thought that the pain was [...]

FDA approves REMS for Fentora, Actiq

Source: drugtopics.modernmedicine.com Author: staff FDA has approved the Risk Evaluation and Mitigation Strategy (REMS) for Fentora (fentanyl buccal tablet) [C-II] and Actiq (oral transmucosal fentanyl citrate) [C-II]. Both products, manufactured by Cephalon, are indicated for management of breakthrough pain in opioid-tolerant patients with cancer. The goals of REMS are to ensure proper patient selection, to prevent accidental exposure and inappropriate conversion between fentanyl products, and to mitigate the potential risks of misuse, abuse, addiction, and overdose. The newly approved REMS will replace the existing risk management programs for Fentora and Actiq. Under REMS, pharmacies and healthcare professionals who prescribe Fentora and Actiq will enroll by completing an education module and knowledge assessment focused on safety information that includes appropriate patient selection. Prescribers will also educate patients as part of the program. Cephalon expects that enrollment in the REMS program will begin in September. “The (REMS) program provides education and systems to support safe use of Fentora and Actiq, preserving availability of the medicines to patients through retail pharmacies and using other systems already familiar to prescribers and pharmacists,” said Lesley Russell, MB,ChB, MRCP, Cephalon’s chief medical officer. When implemented, the REMS will provide checks and balances within the distribution channel to provide safeguards that will help ensure that the medications are appropriately dispensing to qualifying patients. All stakeholders can enroll in the system any time beginning in September. There will be a transition period of about 6 months following the launch of REMS after which no prescription may be dispensed, [...]

FDA approves fentanyl buccal film for breakthrough cancer pain

Source: www.medscape.com Author: Yael Waknine The US Food and Drug Administration (FDA) has approved a fentanyl buccal film (Onsolis, Aveva Drug Delivery Systems under license from BioDelivery Sciences International, Inc) for the management of breakthrough pain in patients with cancer aged 18 years and older who receive around-the-clock opioid therapy and are able to safely use high doses of additional opioid agents. Because fentanyl is subject to abuse and misuse, the product was approved with a risk evaluation and mitigation strategy that includes a restricted distribution program requiring registration of prescribers, pharmacies, and patients. The program emphasizes the need for clinician and pharmacist education and patient counseling regarding the attendant risks of fentanyl therapy. "Onsolis can provide strong pain relief to patients who are opioid tolerant. But for patients who are not opioid tolerant, it can lead to overdose, sudden serious breathing difficulties and death," said Bob Rappaport, MD, director, Division of Anesthesia, Analgesia and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, in an agency news release. "For this reason, Onsolis should be prescribed only under the safeguards provided by the FDA-required [risk evaluation and mitigation strategy] and by health care professionals knowledgeable about Onsolis and the use of potent opioid medications." A boxed warning in the prescribing monograph for fentanyl buccal film advises that the product should not be used for the management of migraines, dental pain, or postoperative pain or in patients who use opioids intermittently on an as-needed basis. The fentanyl buccal film [...]

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