Tuesday, November 5, 2013

Nov 2013 – Pain Product Announcements & Warnings

Pain Product AnnouncementsFeatured 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.

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2 comments:

Husband of a 14 year pain patient said...

The rescheduling of Hydrocodone is wrong, and does harm to the pain patient……
RE:” FDA Announces Plan for Hydrocodone Combination Products Reclassification”
I have to point out that it was not just “some patients” who expressed concern, it was many patients. Also your statement “the reclassification could result in an improvement in the balance between safety and continued access for patients who need continuous pain relief.” I ask you why is it safe to make a patient drive 200miles round trip to pick up a script and then drive to the pharmacy and wait for the script every 30 days, when the patient could have 6 fills prescribed, thus minimizing the risk of the patient in all cases. Let’s make high blood pressure and diabetics do the same. Why not? If it is so much better for the Intractable pain patient to have to go out of their way every single month to receive their medical treatment? There will be continued abuse of these products regardless of their classification, but scheduling them to the next level does not help the patient. Not only that caregivers like myself have to spend countless hours of our time tracking prescriptions and maintaining care. This restricts the patient even more. We wanted to travel over Christmas and Thanksgiving, but cannot. Why? Because the scripts get filled on the 30th of each month and they won’t do early fills, so know we are restricted to staying close to home to get the scripts filled…. We can’t even leave the state to visit a 75yr old mother, because the next state won’t fill an out of state schedule II or III. Could you imagine doing this to all long term patients (Diabetes, Hi BP, etc etc etc)? Oh and just because the scripts are filled on the 30th, don’t think for one minute the doctor will take a call to write the script while their office is on vacation… so now what? And on and on and on….. The rescheduling of Hydrocodone is wrong, and does harm to the pain patient……

Coonhound said...

I would like to share the main reason WHY hydrocodone is one of the top prescribed medications. This is due to the fact that it IS a Schedule III medication and the most effective pain med a doctor can give w/out popping up on DEA radar(and no hassle using triplicate Rx).The FDA & PROP, would have us believe that nothing will change for patients who really need hydrocodone. That is rich, a real laugher. Most doctors are already living in fear of the DEA and tailor their prescribing practices around what schedule a medication is, and this behavior will NOT change. Most of those receiving Schedule III pain meds will soon receive an inferior medication such as tramadol, codeine (I'm allergic), or NSAID(which cause much more damage to the body).

We must also add in the COST of extra doctor appointments. Patients most affected are those on a fixed income for disability like myself.(systemic sarcoidosis & lupus/mctd overlap). It's one more roadblock for legitimate patients,those lucky enough to receive care.While these precautions are added to protect patients & prevent diversion, like we aren't adults, addicts will still get their hydrocodone. The cost will just rise and more crime committed.

Despite the current 'epidemic' I am not convinced that patient safety and diversion are the real reasons for the crackdown. Law enforcement officials,drug treatment beaurocrats, and correctional workers need a 'mission' to keep current funding at high levels. The ax falls on pain meds due in part to changing attitudes toward marijuana. They need a new boogeyman drug and opioids are it. Big pharm needs this war as well to ensure immense profits due to the 'need' for new pain meds with built in abuse deterrents; see the new Oxycontin/OPs. Its sad that hard working tax payers and patients w/ horrible unrelenting pain pay for this persecution.

*While everyone is celebrating the FDA's recent ruling on label changes,pharmacies and doctors are nevertheless changing the way CPP regardless of the laws, labels, or warnings. This is due fear and repression waged on (and by) the medical system and in the arena of public opinion.

I'm fortunate to have a long standing relationship with my pharmacy, allowing me to receive methadone every month w/out having to do the pharmacy crawl. One day when the regular pharmacist wasn't there, the one covering told me that I was the only customer that received or would receive this medication. This made me feel empathy for patients just starting opioids. This is THE cheapest and most effective pain med for nerve pain. It is virtually unavailable to most. When I first moved to the area I visited countless pharmacies trying to fill my RX, from a legit pain clinic located in a major medical center's complex, with no luck. Pharmacists were 'uncomfortable' with filling or just didn'tCARRY a medication LIKE THAT. While doctors and patients may win battles like the defeat of PROPs label changes, we are seriously losing major ground in the war for pain treatment. The saddest thing about this is the reversing of all the gains made by both groups in the last 15 yrs. If pharmacists are uncomfortable filling methadone, how uncomfortable is it for those who rely on it as a major component of a comprehensive CP Tx regimen. I was there when it the norm to be ignored despite having a known disease process causing the pain. I may well be one of the last patients in the country that received opioid medication BEFORE an actual diagnosis. Our family doctor since a small boy believed me when I told him I was in excruciating pain BEFORE the cause of it was determined. I feel for those with little known rare diseases that wait years for a diagnosis while treated as addicts/scum because they haven't had good fortune to currently have a 'label' like lupus or MS

Thank you doctor for all that you do in your efforts to help those with chronic pain.

Coonhound