FDA Actions
December 1, 2013
The FDA is recommending that hydrocodone-containing pain medications (Vicodin, Norco, Lortab, and others) be upgraded from schedule III to schedule II. The move would put significant restrictions on the drugs, including requiring a physician signature for each prescription, no refills, and no phone or fax prescriptions. Hydrocodone would join other powerful opioids including oxycodone, morphine, fentanyl, and methadone in the more restricted schedule II category. The FDA is reacting to the epidemic of prescription drug abuse and addiction that has decimated some communities in this country and has led to the overdose by tens of thousands, including teenagers and young adults. Prescription drug overdoses now outnumber illegal drug overdoses 3:1. The Drug Enforcement Agency has been pushing for stronger controls on hydrocodone for years, but physician and pharmacy organizations have successfully argued that the change unfairly impacts legitimate patients and would increase physician and pharmacy workloads. Hydrocodone/acetaminophen combination drugs were the most frequently prescribed medications in the United States last year. The change is likely to take effect by mid-2014.
Meanwhile, the FDA has approved an extended-release hydrocodone product for the management of severe pain requiring daily, around-the-clock treatment. The drug is an extended-release formulation of hydrocodone that is dosed twice a day. It is available in six strengths — 10, 15, 20, 30, 40, and 50 mg capsules. Because of concerns of addiction and abuse, and the greater risk of overdose and death associated with extended-release and long-acting formulations, hydrocodone extended-release should be reserved for patients in whom alternative treatment options are ineffective, not tolerated, or one otherwise provides inadequate pain management. The approval of hydrocodone extended-release was controversial given that the drug is not packaged as a tamper-proof capsule, theoretically allowing it to be crushed, chewed, or even injected. Experience with abuse of extended-release oxycodone (OxyContin) prompted the FDA to require Purdue Pharmaceuticals to reformulate the drug into a tamper-proof capsule in 2010. Some in the FDA felt this new formulation of hydrocodone should be similarly packaged, but the drug was approved without such restrictions. Hydrocodone extended-release will be schedule II, and marketed by Zogenix Inc. as Zohydro.
The FDA has approved two new drugs to treat pulmonary arterial hypertension (PAH). Macitentan is a dual endothelin-receptor antagonist, while riociguat is a first in class soluble guanylate cyclase stimulator. Macitentan is a once-daily pill that is approved to treat PAH. Its safety and efficacy was established in a 2-year, randomized, placebo-controlled trial of 742 patients. Patients in the active treatment group had delayed progression of the disease and improved symptoms. Macitentan is manufactured by Actelion Pharmaceuticals and will be marketed as Opsumit. Riociguat is also an oral agent given three times a day. It is approved for PAH and also for chronic thromboembolic pulmonary hypertension (CTEPH), the first drug to be approved for this latter indication. Safety and efficacy for PAH was shown in a trial of 443 patients in which treated patients had improved 6-minute walk times after 12 weeks. It was shown to be effective for CTEPH in a study of 261 patients in which treated patients had improved walk times at 16 weeks. Riociguat is marketed as Adempas by Bayer HealthCare.
An FDA advisory group has recommended approval of simeprevir and sofosbuvir, two long-awaited agents to treat hepatitis C virus (HCV). Both are oral drugs and have higher cure rates compared with currently available agents. Simeprevir is a protease inhibitor, similar to currently available agents such as telaprevir and boceprevir, while sofosbuvir is a new type of hepatitis c antiviral called a nucleotide analogue (or “nuke”). Sofosbuvir has been highly anticipated as clinical trials suggest that it results in sustained virological responses as high as 90%, and may eventually be part of an all-oral regimen for HCV along with ribavirin. The FDA is expected to approve both drugs by mid-December. Simeprevir will be marketed by Johnson & Johnson while sofosbuvir will be marketed by Gilead Sciences.
This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5404. E-mail: [email protected].
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