Lesinurad is a once-daily oral inhibitor of uric acid transporter 1 that is currently in phase 2 trials to treat hyperuricemia and gout.13,14 At the May European League Against Rheumatism (EULAR) meeting in London, results of the phase 2 clinical trials were reported. Over one month, 87% of patients that received combination therapy with allopurinol and lesinurad 600 mg once daily had a rapid and sustained serum urate level lowering to below 6 mg/dL. In addition, patients that received allopurinol in combination with lower doses of lesinurad, 400 mg once daily and 200 mg once daily, had 76% and 71% reductions, respectively, compared with allopurinol monotherapy (28% reduction). The results were both clinically and statistically significant (P<0.001).
The manufacturer of oxycodone (Remoxy) has reported results of a clinical trial in individuals with a history of “getting high” from prescription pain medications and found that Remoxy is more difficult to abuse than OxyContin and OxyIR.15 This twice-daily, long-acting oxycodone formulation to treat moderate-to-severe pain contains a very thick liquid in a hard gelatin capsule intended to resist tampering that would lead to rapid oxycodone release. Patients were unable to chew it for more than 48 seconds even though they were allowed to chew it for up to 90 seconds. This was due to its unpleasant taste and texture. As reported in the March issue of The Rheumatologist, the NDA for this drug was resubmitted in late December 2010.16 The FDA is scheduled to make a decision on this agent by June 23.
A subcutaneous monoclonal anti–TNF-α nanobody, ozoralizumab (ATN-103), for treating active RA has completed phase 2 proof-of-concept trials.17 In the trials, it was administered as three different doses once monthly and two different doses every two months versus placebo. The highest dose of 80 mg, administered every four weeks, resulted in statistically significant improvements in ACR20 responses versus placebo at Week 16. Improvements in clinical scores, ACR50, ACR70, Disease Activity Score (DAS) 28, and EULAR response at this dose were seen at Week 16, as well. An open-label safety extension trial was also started and is expected to be completed in early 2012.
Evaluated results of pooled data from phase 3 clinical trials to treat fibromyalgia with sodium oxybate (JZP-6) were reported at the May American Pain Society Annual Meeting.18 The investigators concluded that these analyses showed that in fibromyalgia patients, the drug demonstrated efficacy for pain reduction whether or not disease severity was moderate or severe at baseline. There was a greater than or equal to 30% reduction in pain with sodium oxybate dosed at 4.5 gm and 6 gm (versus placebo-treated patients) in a greater proportion of patients with moderate and severe pain and moderate and severe disease activity. Sodium oxybate is not currently FDA approved for treating this condition, but is still an active pharmaceutical pipeline agent for this use.19