Tuesday, December 1, 2009

Dec2009 – Pain Product Announcements & Warnings

AnnouncementsFeatured Items: generic fentanyl citrate approval, capsaicin skin patch (Qutenza) approval, diclofenac sodium topical (Pennsaid) approved for knee OA, generic tramadol hydrochloride approval.
— All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Generic Oral Transmucosal Fentanyl Citrate (OTFC) — Receives FDA Approval
Mallinckrodt (subsidiary of Covidien) and Barr Laboratories each reported a November 2009 approval of fentanyl citrate, a generic version of Actiq, the pain-relieving lollipop made by Cephalon. This oral transmucosal fentanyl formulation — indicated for the management of breakthrough cancer pain in opioid-tolerant patients 16 years of age and older — is an opioid analgesic Class II controlled substance. The product will be produced by both companies in 6 dosing strengths and is expected to be launched in early 2010. Since oral transmucosal fentanyl citrate can be abused in a manner similar to other opioid agonists, it is important to read the Risk Minimization Plan and the patient Medication Guide for complete safety information.

Capsaicin Skin Patch (Qutenza™ 8%) — Receives FDA Approval for Postherpetic Neuralgia Pain
In November 2009, the FDA approved Qutenza — a novel medicated skin patch that delivers a synthetic form of capsaicin, a compound found in chili peppers that provides heat sensation — to treat pain due to postherpetic neuralgia (PHN). Unlike systemic analgesics, Qutenza targets the regional nerve pain of PHN (a condition that sometimes occurs following shingles) which can be excruciating and affect quality of life. Clinical trials reported up to 12 weeks of pain reduction following a single one-hour dermal application. Patches are applied by a healthcare professional and can be cut or combined (up to 4 patches) to cover any pain-affected skin area. The most common adverse effects were transient and included application site redness, itching, skin pain, and a moderate increase in blood pressure. Episodes of drowsiness or drug-drug interaction are reported to be unlikely. To learn more, see the full prescribing information.

Diclofenac Sodium Topical Solution (Pennsaid®) — FDA-Approved to Treat Symptoms of OA
Covidien and Nuvo Research announced the November 2009 FDA approval of Pennsaid — a topical, transdermal non-steroidal anti-inflammatory drug (NSAID) — developed to treat the symptoms of knee osteoarthritis (OA). The product was developed using innovative, combination drug-delivery technology to provide site-specific analgesia via the skin, thereby limiting potential systemic complications. Clinical trials enrolling more than 2,500 patients showed results comparable to oral diclofenac for effective symptom-relief of pain and stiffness. For more information on administration and safety, see the Pennsaid prescribing information and the medication guide for NSAIDs.

Generic Tramadol Hydrochloride — FDA Approved
In November 2009, the FDA approved Par Pharmaceutical Industries’ application for a generic version of Johnson & Johnson’s chronic pain drug, Ultram® ER. The extended-release pain reliever is approved to manage moderate to moderately severe chronic pain in adults who require continuous treatment for an extended period of time. Par plans to begin shipping the product immediately and will offer 100 mg and 200 mg strengths.