Featured Items: hydrocodone (Zohydro ER) approved as a single-entity product; FDA announces plan for hydrocodone combination products reclassification; diclofenac capsules (Zorvolex) approved as new NSAID formulation; tocilizumab (Actemra) subcutaneous formulation approved for RA; certolizumab pegol (Cimzia) approved for active psoriatic arthritis; methotrexate (Otrexup) self-injection device approval;. — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.
Hydrocodone Extended-Release Capsules (Zohydro ER®) – FDA Approved
The FDA announced an October 2013 approval of the single-entity, extended-release, oral hydrocodone bitartrate product Zohydro ER for pain management. The agent is a Schedule II controlled substance manufactured by Zogenix, Inc. and is indicated for the management of severe pain when continuous long-term treatment is needed and other treatment options have been ineffective. Six Zohydro ER strengths — 10-, 15-, 20-, 30-, 40-, and 50-mg — will offer healthcare practitioners a wide range of titration options. Zohydro ER drug labeling conforms to stronger September 2013 FDA labeling standards now required to communicate the associated risks and safety concerns for all ER/LA opioid analgesics. Zogenix will also be required to perform post-marketing studies on the product to evaluate the incidence and risks of abuse, misuse, addiction, overdose, hyperalgesia, and death when patient use is longer than 12 weeks. Healthcare practitioners are urged to alert patients to the fact that Zohydro ER should not be used as an as-needed pain reliever. A related news story (Associated Press) reported several statements of surprise on the part of individuals and lawmakers who were aware that FDA advisors had reviewed the drug and voted against product approval in December 2012. For more information and safe prescribing instructions, read the FDA Press Announcement as well as the prescribing information and patient medication guide.
FDA Announces Plan for Hydrocodone Combination Products Reclassification
In October 2013 the FDA released an announcement regarding its decision to submit a formal recommendation to the U.S. Department of Health and Human Services for the reclassification of hydrocodone combination products from Schedule III to Schedule II. The proposed change would mean that analgesic products like Vicodin® — a potent combination of hydrocodone and acetaminophen — would be held to more restrictive controls. While some persons have expressed concern that the prescribing hydrocodone combination pain relievers will become less convenient for practitioners and patients, the reclassification could result in an improvement in the balance between safety and continued access for patients who need continuous pain relief. For more information, see the FDA Drug Safety Announcement.
Diclofenac Capsules (Zorvolex™) – FDA Approved NSAID Uses a Small Particle Formulation
Iroko Pharmaceuticals announced an October 2013 U.S. FDA approval of Zorvolex, a nonsteroidal anti-inflammatory drug (NSAID), for the adult treatment of mild to moderate acute pain. Zorvolex is the only NSAID that uses a proprietary SoluMatrix Fine Particle Technology™ for faster dissolution and offers dosages that are 20% lower than other available diclofenac products. The product is available in 18 mg and 35 mg strengths and was designed to improve absorption rates for faster pain relief at lower NSAID doses while also reducing the risk of serious adverse events often associated with higher doses of NSAIDs. The approval was granted based on data from a phase 3 multicenter, randomized study that reported results showing significant pain relief in treated patients when compared with study participants who received placebo. Similar dosing strengths of Zorvolex capsules are not interchangeable with other formulations of diclofenac. Standard cautions related to NSAID use should be considered when prescribing. For full administration instructions, please read the Zorvolex prescribing information and medication guide.
Tocilizumab (Actemra®) — New Subcutaneous Formulation Approved
Genentech announced an October 2013 FDA approval of a subcutaneous formulation of tocilizumab for adults who have failed to get adequate relief from moderate to severe rheumatoid arthritis (RA) symptoms with methotrexate or other disease-modifying antirheumatic drugs (DMARDs). This is the only humanized interleukin-6 receptor-antagonist monoclonal antibody to be approved for both subcutaneous and intravenous administration. Intravenous Actemra was approved in 2010 and, according to a Genentech Press Release, the subcutaneous product will be available in November 2013. Two phase 3, randomized, double-blind clinical studies of Actemra — known as SUMMACTA and BREVACTA — included more than 1800 patients with moderately to severely active RA in 33 countries. SUMMACTA compared the efficacy and safety of subcutaneous and intravenous formulations, each administered in combination with DMARDs, and BREVACTA studied subcutaneous Actemra versus placebo, both also administered with DMARDs. The results showed positive data with similar improvements in tender and swollen joints in all treated patients at 24 weeks using the American College of Rheumatology 20 (ACR20) response criteria. The safety profiles of the 2 formulations in these studies were consistent, with the exception of dermal injection site reactions in subcutaneous administration. Since patients taking Actemra may have an increased risk for developing serious infections, practitioners are advised to assess each patient for infection risk and to order tuberculosis and blood tests before initiating treatment. To learn more, see the product’s prescribing information and patient medication guide.
Certolizumab Pegol (Cimzia®) – FDA Approval for Active Psoriatic Arthritis
The FDA granted a September 2013 approval of UCB Pharma’s Cimzia for adult treatment of active psoriatic arthritis (PsA). This chronic inflammatory condition causes joint pain, swelling, and stiffness, frequently striking patients who have psoriasis. Cimzia — a tumor necrosis factor (TNF) inhibitor — received previous approval for adult treatment of moderate to severe active rheumatoid arthritis and as therapy for moderate to severe Crohn’s disease in patients who have had an inadequate response to conventional therapy. This third approval was based on data showing positive results from the RAPID-PsA study. Treated patients in this phase 3 multicenter placebo-controlled trial received a 400 mg loading dose of Cimzia every 2 weeks for 4 weeks, followed by either one 200 mg dose every 2 weeks or a 400 mg dose every 4 weeks. Results at 12 weeks showed a significant improvement in American College of Rheumatology 20% (ACR20) response criteria in patients in both treatment groups when compared with participants in the placebo group. The safety profile for PsA patients in this study was similar to that shown in patients taking certolizumab for rheumatoid arthritis. For full administration and safety instructions, read the Cimzia prescribing information and medication guide.
Methotrexate (Otrexup™) – Self-Injection Device Approved
In October 2013 the FDA approved a device for subcutaneous administration of methotrexate intended for use by adults with active severe rheumatoid arthritis or psoriasis who have had an inadequate response to first line therapy. Otrexup™, a disposable auto-injector for single-dose self-injection, was also approved for children with polyarticular idiopathic arthritis. Antares Pharma published a press release stating that study data results showed that subcutaneous methotrexate demonstrated increased bioavailability at every dose when compared to oral methotrexate. Otrexup provides a new administration route for patients who have experienced troublesome gastrointestinal effects with oral methotrexate without the need to switch to other more expensive therapies. Full administration details and safety cautions, including the risks related to severe toxic reactions, can be found in the Otrexup prescribing information.