FDA reviewers expressed concern over the potential rate of abuse with hydrocodone bitartrate extended-release capsules (Zohydro ER); they are currently reviewing an NDA for the drug.5 The makers of hydrocodone extended-release are seeking the drug’s approval for the management of moderate to severe chronic pain when an around-the-clock opioid analgesic is needed for a prolonged time. If approved, it will be a controlled substance Class II. Part of the advisory group discussion was related to not having an abuse-deterrent in this formulation and the potential for abuse of a single-entity hydrocodone product. Data showed that oxycodone combination products led to about twice as many emergency department (ED) visits than hydrocodone combination products, and that oxycodone-only products led to about six times as may ED visits compared to hydrocodone combination products. A vote was postponed due to Hurricane Sandy but is expected soon.
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Explore This IssueMarch 2013
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Lansoprazole has been FDA approved as a generic for Prevacid. It is available as both 15-mg and 30-mg delayed-release capsules.6
Otrexup was developed to more easily administer subcutaneous (SC) methotrexate (MTX).7 It is a combination product to deliver MTX using Medi-Jet technology. This would make self-administration easier than using intramuscular injections, and potentially improve patient outcomes. Premarketing clinical trials already conducted indicate that RA patients find this delivery system is safe and easy to use to self-administer precise SC MTX doses. This administration also has shown to have improved systemic availability compared to oral dosing.
Tabalumab, an anti–B cell–activating factor (BAFF) monoclonal antibody, is still in phase III clinical trials for RA; however, one trial (FLEX-M) was stopped due to lack of efficacy.8 This agent is also still being investigated for systemic lupus erythematosus (SLE). The company believes that the RA data do not reflect negatively on the SLE data. BAFF promotes B cell survival, proliferation, and activation. In the presence of excess BAFF, B cells are not correctly removed by the immune system and may contribute to RA development. Tabalumab is a human immunoglobulin G subclass 4 monoclonal antibody that inhibits soluble and membrane-bound BAFF.
Tocilizumab (Actemra) received an expanded indication for the treatment of adults with moderately to severely active RA who have had an inadequate response to one or more DMARDs.9 Tocilizumab has been approved for use as monotherapy or in combination with MTX or other DMARDs.
Varicella zoster immune globulin (VZIG; Varizig) has been FDA approved to reduce chicken pox (varicella zoster virus) infection severity in high-risk patients if administered within four days following exposure to varicella zoster virus.10 This is the only immune globulin product approved for this use. In 2006, an earlier FDA-approved varicella zoster immune globulin product was removed from the market. The currently approved VZIG product has been available for use under an investigational expanded access protocol. Susceptible individuals treated in the expanded access protocol had low rates of severe VZV infection compared with untreated individuals. Patients without varicella zoster virus immunity who become exposed are at risk of developing severe infections that may be fatal. This product provides a treatment to lower the risk of severe, potentially fatal varicella infections in vulnerable patients, which include patients who are immunocompromised, pregnant women, and infants exposed during pregnancy or after birth. The most common side effect reported was pain at the injection site.