A supplemental biologics license agreement has been submitted for infliximab injection (Remicade) for the treatment of moderately to severely active ulcerative colitis in pediatric patients who have not had an adequate response to conventional therapy.9 The data on which this study is based evaluated patients six to 17 years of age who had an inadequate response to agents such as 6-mercaptopurine, azathioprine, corticosteroids, and 5-aminosalycylic acid.
The new drug application (NDA) for oxycodone tablets (Remoxy) was recently resubmitted to the FDA.10 This agent is a twice-daily, long-acting formulation of the opioid oxycodone to treat continuous, around-the-clock, moderate to severe pain. This formulation consists of a high-viscosity liquid formulation in a hard gelatin capsule designed to provide steady pain relief while resisting common methods of tampering intended to result in rapid oxycodone release.
The NDA for oxycodone tablets (Acurox) has been submitted to the FDA.11 This agent is an immediate release tablet containing oxycodone for treating moderate to severe pain. This formulation also utilizes Acura’s Aversion Technology designed to deter opioid abuse by intravenous injection of dissolved tablets and snorting of crushed tablets.
Endo Pharmaceuticals has received a complete response letter from the FDA for a new crush-resistant formulation of oxymorphone hydrochloride extended-release tablets (Opana ER).12 The letter did not request additional clinical studies be conducted for approval. The manufacturer has begun to address the issues in the letter and expects to respond to the FDA by mid-2011. The current formulation of oxymorphone hydrochloride extended-release tablets are FDA-approved for relieving moderate to severe pain in patients that require continuous, around-the-clock opioid treatment for an extended period of time.13
RDEA594, a selective URAT1 inhibitor, is currently undergoing phase II clinical trials for the treatment of gout and hyperuricemia.14,15 Preliminary results from a phase IIb study of RDEA594 in combination with allopurinol showed a statistically significant improvement of 89% in reducing serum uric acid (sUA) levels after four weeks of treatment, compared with allopurinol monotherapy. Additionally, the secondary efficacy endpoint of achieving a reduction in the sUA below the clinically relevant target of less than 6 mg/mL after four weeks of combination therapy was also statistically significant compared with the combination of allopurinol and placebo. The study was a multicenter, double-blind, randomized, placebo-controlled, 28-day dose-response safety and urate-lowering efficacy trial.
The Sandoz generic division of Novartis has begun trials of their biosimilar version of Roche’s monoclonal antibody rituximab (Rituxan/MabThera), for the treatment of RA.16 When the FDA develops new biosimilar rules, companies expect they will include shortened clinical testing of products.17