Featured Items: fentanyl sublingual spray (Subsys) approved for breakthrough cancer pain; FDA safety alert regarding Endo/Novartis opioid product packaging problem; natalizumab (Tysabri) FDA safety alert; FDA approval of TIRF REMS program. — All brand names are trademarks of their respective manufacturers. Compiled by: Winnie Dawson, MA, RN, BSN.
Fentanyl Sublingual Spray (SUBSYS®) — FDA Approved for Breakthrough Cancer Pain
INSYS Therapeutics made a January 2012 announcement that their novel single-dose sublingual fentanyl spray formulation was approved by the U.S. Food and Drug Administration. SUBSYS was developed and approved for the treatment of breakthrough cancer pain, offering earlier onset of pain relief for appropriate adult patients who are already receiving opioids for persistent cancer pain. The FDA approval was based on the results of a placebo-controlled, double-blind crossover study in about 100 opioid-tolerant patients who had successfully completed the titration phase of the study. Study participants received SUBSYS doses that varied from 100 mcg to 1600 mcg per dose, based on pain intensity. Treatment of each breakthrough pain episode is limited to two doses of SUBSYS which can be administered 30 minutes apart. When compared with placebo, study results showed that SUBSYS provided a statistically significant greater reduction in pain intensity at 30 minutes after administration. Common adverse events were nausea, vomiting, constipation, dyspnea, and somnolence. The safety of SUBSYS was evaluated in more than 350 opioid-tolerant patients. As with all opioid drugs, respiratory depression is the adverse reaction of greatest concern. A related news story (Marketwire) reports that SUBSYS will be launched late in the first quarter of 2012 — individual, disposable spray units will be available in 100 mcg, 200 mcg, 400 mcg, 600 mcg, and 800 mcg strengths. Please read the SUBSYS Medication Guide for full administration and safety instructions. This product will come under the newly-approved TIRF REMS Access program (see below).
FDA Safety Alert – Opioid Product Packaging Problems
In a January 2012 FDA safety communication, patients and healthcare professionals were alerted to the fact that 9 Endo Pharmaceutical opioid drug products, manufactured by Novartis Consumer Health, may have experienced problems during packaging. A few reports of tablets of one drug type appearing in a bottle of another opioid product were identified by pharmacists. Patients and healthcare professionals are urged to examine all opiate medications from Endo Pharmaceuticals to ensure that all tablets in a product package are the same. The products included in this public health advisory are Opana, Opana ER, Oxymorphone HCl, Percocet, Percodan, Endocet, Endodan, Morphine Sulfate, and Zydone. For complete information and a visual guide to tablet identification, please see the FDA Drug Safety Communication.
In another press release related to these packaging concerns, Novartis also alerted consumers to their voluntary recall of specific lots of 4 over-the-counter brands — including Excedrine®, NoDoz®, Bufferin®, and Gas-X Prevention® — in various formulations and packaging configurations. For further information and a list of products related to this recall, please see the Novartis Press Release.
FDA Safety Update – Natalizumab (Tysabri®)
In a January 2012 safety communication, the FDA reminds healthcare professionals and consumers of the increased risk of Progressive Multifocal Leukoencephalopathy (PML) associated with the use of Tysabri. As an immunomodulator, a class of drugs that helps stop certain types of immune cells from causing damage to the body, Tysabri is used in the treatment of the autoimmune disorders of Crohn's disease or Multiple Sclerosis. Patients taking Tysabri who test positive for anti-JCV antibodies — reflecting prior exposure to John Cunningham Virus (JCV) — are at higher risk for PML, a rare but serious brain infection. Beginning in January 2012, the Stratify JCV Antibody ELISA test is available as the first allowable FDA test to identify a patient’s prior exposure to JCV, one factor related to PML risk. For complete information, read the FDA Drug Safety Communication and the FDA News Release regarding the Stratify JCV Antibody ELISA test.
FDA Approval of Shared TIRF REMS
The FDA approved a shared Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products. The program was designed to streamline the REMS process while ensuring safe access to opioid pain medications used to manage breakthrough cancer pain in opioid-tolerant adults. The branded drugs included in the TIRF REMS Access program are Abstral, Actiq, Fentora, Lazanda, and Onsolis. [Note: Additionally, the news source Marketwire has reported that INSYS Therapeutics plans to launch SUBSYS, a recently approved single-dose sublingual fentanyl spray, under the TIRF REMS shared system (see above).] This FDA decision will allow prescribers and pharmacists to enroll in one shared system for all transmucosal immediate-release fentanyl drugs beginning in March 2012. Prescribers and pharmacies that have already enrolled for at least one of the named drugs in an individual REMS program will automatically be transferred to shared TIRF REMS Access. For more information, read the FDA News Release and visit the TIRF REMS website currently under construction at http://www.tirfremsaccess.com/.
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