Friday, July 24, 2009

Pain Management Product Announcements & Warnings

Featured Items: acetaminophen drops, almotriptan malate (Axert), Bryan Cervical Disc device, diclofenac potassium (Zipsor), diclofenac + potassium bicarbonate (Cambia), fentanyl buccal (Onsolis), golimumab (Simponi), ibuprofen injectable (Caldolor), sumatriptan injection (Sumavel DosePro), tapentadol (Nycynta).
— All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.


Concentrated Acetaminophen Drops – Manufacturer Recall
The U.S. FDA and Brookstone Pharmaceuticals notified healthcare professionals and consumers of a July 2009 recall of all 16 oz. bulk containers of concentrated acetaminophen drops (NDC#42192-504-16). There is concern that the packaging, which was very similar to that used for regular strength liquid acetaminophen, could result in possible dosing errors. See FDA announcement.

Tapentadol (Nucynta™) Immediate Release Tablets – Now Available
Following approval last November, 2008, Nucynta has been given a controlled-substance Schedule II classification and is now available in 50 mg, 75 mg, and 100 mg strengths for patients aged 18 years and older. Tapentadol hydrochloride — a new analgesic option for the treatment of moderate to severe acute pain — combines two mechanisms of action, mu-opioid receptor agonism and inhibition of norepinephrine reuptake. See prescribing information.

Fentanyl Buccal Film (Onsolis®) – FDA Approval For Break-thru Cancer Pain
In July 2009 the FDA approved Onsolis, a new fentanyl formulation delivered through a dissolvable film that adheres to the inside of the user's cheek. It was developed for adult patients with cancer who are already on a regimen of opioid medication for persistent pain but also need a strong agent for severe breakthrough pain that is unresponsive to other analgesics. The product carries a “black box” warning and an associated REMS (Risk Evaluation and Mitigation Strategy) program. See our prior Update post for REMS details and access prescribing information.

Ibuprofen Injectable Formulation (Caldolor™) Approved
Cumberland Pharmaceuticals announced a June 2009 FDA approval of its injectable ibuprofen product for the treatment of pain and fever. This is the first ibuprofen injectable and is approved for hospital use in patients who are unable to take oral analgesic medications. To date, the manufacturer has not published full prescribing information but expects the product to be available before the end of 2009. See press release.

Diclofenac Potassium (Zipsor™) – Liquid NSAID Gets FDA Approval
In July 2009 the FDA approved Zipsor — diclofenac potassium liquid-filled soft gelatin capsules — for the relief of mild to moderate acute pain in adults. The manufacturer, Xanodyne, expects to have the product ready for market within a few months. See prescribing info.

Bryan Cervical Disc – FDA Approved for Disc Replacement
Medtronic received approval in May 2009 from the FDA for the Bryan Cervical Disc. This medical device is approved as a replacement disc for a diseased or bulging C3- to C7-level cervical disc that is causing radicular, intractable neck or arm pain. Adult patients with good bone quality who have not had pain relief after a minimum of 6 weeks of conservative therapy may be disc replacement candidates. More info is available at Medscape and in the draft package insert.

Subcutaneous Sumatriptan Injection (Sumavel™ DosePro™) Approved
Zogenix, Inc. received a July 2009 FDA approval of Sumavel DosePro — a needle-free delivery system for subcutaneous administration of sumatriptan for the treatment of cluster headaches and migraine headache, with or without aura. The product is designed for patient self-administration in 3 easy steps using a proprietary combination of sumatriptan and a prefilled drug-delivery system. See press release.

Diclofenac-Based NSAID + Potassium Bicarbonate (Cambia™) For Migraine
In June 2009 the FDA approved Cambia, a combination drug from Kowa Pharmaceuticals America for the treatment of acute adult migraine, with or without aura. In addition, Cambia was effective in providing relief from photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea associated with migraine. Studies demonstrated a more favorable safety profile than triptans currently on the market. Kowa is preparing to launch the product before year’s end — see package insert.

Almotriptan Malate (Axert®) – Approved for Migraine Relief in Adolescents
Axert, originally approved in 2001 for adult migraine pain relief, received a June 2009 FDA approval for acute treatment of migraine headache in adolescent patients aged 12 to 17 years, making it the first triptan to be approved for migraine therapy in adolescents. See prescribing information.

Golimumab (Simponi™) – First FDA-Approved Monthly RA Treatment
Centocor Ortho Biotech, Inc. announced an April 2009 FDA approval of Simponi for the treatment in adults of moderate to severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. This anti-TNF-alpha agent is the first once-monthly therapy of its kind, administered as a 50 mg subcutaneous injection alone or in combination with methotrexate. Caution should be observed regarding the potential risk of serious infections [see info] associated with TNF-alpha blockers. See prescribing information.