The five-year clinical efficacy, radiographic and safety findings of subcutaneous golimumab (Simponi) in treating adults with active psoriatic arthritis were recently reported.9 ACR20 responses after Week 252 occurred in 63–70% of patients that received once weekly 50 mg or 100 mg subcutaneous golimumab with or without methotrexate. Additionally, there was a greater than or equal to 75% improvement in the Psoriasis Area and Severity Index scores for 61–72% of patients with at least 3% of body surface area involvement. ACR50 responses were obtained in 43–51% of patients, and ACR70 responses were seen in 31–36% of patients. Among 267 patients who received methotrexate and had both baseline and five-year radiographs obtained, progression (radiographic) appeared to be slightly reduced. No new safety signals were identified.
Although the controversy around hydrocodone bitartrate extended-release (Zohydro ER) continues, a new hydrocodone bitartrate product with abuse-deterrent features moves closer to obtaining regulatory approval.10 Purdue Pharma’s hydrocodone bitartrate tablet is hard to crush and snort or inject, but Zohydro ER has no abuse-deterrent features. The not-yet-FDA-approved product is being investigated to treat low back pain, and it would likely be used for other types of pain if needed (off-label) once gaining approval. Hydrocodone-based products are some of the most widely prescribed drugs in the U.S. The FDA continues to tighten prescribing restrictions on opioid analgesics to help curb abuse, diversion and addiction.
If you were thinking, “Do we need another NSAID or a new formulation for one?” think again. The newest product is a lower dose indomethacin capsule, Tivorbex, in 20 mg and 40 mg strengths.11 It is approved for treating mild to moderate acute pain in adults and carries the same warnings as other NSAIDs, as well as the same adverse effects of other indomethacin products.
The generic of Aciphex 20 mg tablets, rabeprazole sodium delayed-release tablets, is now available.12
The generic of Evista 60 mg tablets, raloxifene tablets, is now available.13 Teva Pharmaceuticals has market exclusivity until September 2014. At that time, additional generics should become available, and the price should decrease.
Drug Safety
Epidural corticosteroid injections, including betamethasone, dexamethasone, hydrocortisone, methylprednisolone, triamcinolone and others, carry the risk of rare, but serious neurologic problems.14
This new FDA warning, although not related, brings back unfortunate memories of the 2012–2013 New England Compounding Center debacle related to cases of meningitis and patient deaths due to contaminated corticosteroid injections. The FDA warns that epidural corticosteroid injections may result in rare but serious adverse events, including paralysis, vision loss, stroke and death. The FDA states that the effectiveness and safety of epidural corticosteroid administration has not been established and is not FDA approved for this indication. New information is now required in the Warnings section of drug labels for injectable corticosteroids describing these risks.
