Salzyme and selectobac dry mouth mouthwash (Orazyme) is a combination of six enzymes and other ingredients that has been FDA approved as a sugar-free rinse for the relief of xerostomia.11 The formulation also is meant to inhibit gram negative bacterial growth and improve oral health to relieve general xerostomia symptoms such as oral discomfort, difficulty masticating, a rough tongue, and for the relief of mouth sores.
Sequential compression comfort sleeve (Kendall SCD) is a recently FDA-approved device that was developed to reduce venous thromboembolism risk.12 It delivers sequential, gradient, circumferential compression mostly in nonambulatory patients and decreases patient discomfort, including sweating, heat, itchiness, pressure, and skin irritation.
Tacrolimus 5 mg capsules (generic Prograf) have garnered generic approval from the FDA.13
Tapentadol extended-release tablets are undergoing phase III clinical trials for the relief of pain in patients with knee OA.14 Compared to oxycodone, constipation, nausea and/or vomiting were significantly lower with tapentadol. Further studies are ongoing to more specifically delineate its adverse event profile.
Arbaclofen placarbil is undergoing phase III clinical trials for the potential indication of spasticity in multiple sclerosis. It is a prodrug of R-baclofen and a gamma amino-butyric acid agonist.
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Abatacept (Orencia) is under investigation as a subcutaneous (SC) injection and is being compared to the IV formulation.15 The newer version, given as a 150-mg dose, has performed well following an IV loading dose. Response rates were similar between both treatment groups. Injection-site reactions such as itching and erythema were more common with the SC injection, but the overall rate of injection site reactions was 1.1% and 2.5% for the SC and IV injections, respectively.
Arbaclofen placarbil (XP19986) is undergoing phase III clinical trials for the potential indication of spasticity in multiple sclerosis.16 It is a prodrug of R-baclofen and a gamma amino-butyric acid agonist.
Belimumab injection (Benlysta) was recommended for approval as a new treatment for systemic lupus erythematosus (SLE) by an FDA Advisory Panel.17 Belimumab is a monoclonal antibody that targets a protein known as the B-lymphocyte stimulator, or BLyS, which helps mediate the maturation of antibody-producing B cells. In studies, it was dosed as a 10-mg/kg injection every two weeks for the first three doses, then every four weeks thereafter. Belimumab was only slightly better than placebo in reducing lupus symptoms, but patients were also able to decrease the amount of steroids needed to control their disease.
Briakinumab, a potential new agent for treating psoriasis, has had its New Drug Application (NDA) filed with the FDA.18 It targets interleukin-12/23 and has been compared to methotrexate (MTX) and etanercept in phase III clinical trials. At 24 weeks, nearly 82% of patients using briakinumab achieved at least a 75% skin clearance rate compared with about 40% for those using MTX. Complete skin clearance was obtained in 46% of patients compared with 9% of MTX-treated patients. There were three cancers in the briakinumab-treated patients and four serious infections; there were three serious infections in the MTX-treated patients.