opioid tolerant

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, [...]

Oral Cancer Foundation News Team - A2011-07-25T07:44:34-07:00July, 2011|Oral Cancer News|

Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: a randomized, double-blind, placebo-controlled study

Source: Oxford Journals Author: Dr A. L. Finn Abstract Background: Fentanyl buccal soluble film (FBSF) has been developed as a treatment of breakthrough pain in opioid-tolerant patients with cancer. The objective of this study was to evaluate the efficacy of FBSF at doses of 200–1200 μg in the management of breakthrough pain in patients with cancer receiving ongoing opioid therapy. Patients and methods: This was a multicenter, randomized, double-blind, placebo-controlled, multiple-crossover study that included opioid-tolerant adult patients with chronic cancer pain who experienced one to four daily episodes of breakthrough pain. The primary efficacy assessment was the sum of pain intensity differences at 30 min (SPID30) postdose. Results: The intent-to-treat population consisted of 80 patients with ≥1 post-baseline efficacy assessment. The least-squares mean (LSM ± SEM) of the SPID30 was significantly greater for FBSF-treated episodes of breakthrough pain than for placebo-treated episodes (47.9 ± 3.9 versus 38.1 ± 4.3; P = 0.004). There was statistical separation from placebo starting at 15 min up through 60 min (last time point assessed). There were no unexpected adverse events (AEs) or clinically significant safety findings. Conclusions: FBSF is an effective option for control of breakthrough pain in patients receiving ongoing opioid therapy. In this study, FBSF was well tolerated in the oral cavity, with no reports of treatment-related oral AEs.

Charlotte Parker2010-05-26T10:45:17-07:00May, 2010|Oral Cancer News|

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 [...]

Oral Cancer Foundation News Team - A2009-07-24T12:46:13-07:00July, 2009|Oral Cancer News|