Adalimumab (Humira) may soon be used to treat ulcerative colitis because studies have shown that patients taking it had a higher remission rate than placebo-treated patients.5 The FDA is expected to rule in on this use toward the end of this year or in early 2012. It is also being investigated to treat uveitis, hidradenitis suppurativa, and other conditions. Adalimumab faces competition from oral agents for RA and other oral agents for similar immune-mediated diseases. Abbott is also planning to apply for FDA approval to sell adalimumab with a thinner needle to try to reduce patient discomfort. The manufacturer plans to have the smaller needle packaged with the pen devices and with the prefilled syringes.
Explore This IssueSeptember 2011
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The first ceramic-on-metal total artificial hip implant for treating patients with osteoarthritis (OA) was recently FDA approved.6 It is known as the Pinnacle CoMplete Acetabular Hip System and is the first to combine a ceramic ball and a metal socket. Prior approved devices have used combinations of metal, ceramic, and polyethylene plastic. This approval was provided subsequent to a two-year, randomized clinical trial that compared 194 patients who received the new hip implant to 196 patients who received a metal-on-metal hip implant. Two patients who received the Pinnacle CoMplete system required a second surgery to replace their new implant compared with three patients who required a second surgery in the control group. Clinically there were differences between the groups following the hip surgery. Contingent on their approval, the manufacturer is required to conduct a postmarketing study for adverse event and metal ion blood concentrations.
Oxycodone (Oxecta) has been approved by the FDA to treat patients with acute and chronic moderate-to-severe pain where the use of an opioid analgesic is appropriate.7 This agent is the first oxycodone immediate-release formulation that is designed to discourage common methods of tampering such as crushing or dissolving, which are associated with opioid abuse and misuse. This oxycodone also causes nasal irritation if snorted. The manufacturer is being required to conduct a study to determine whether this analgesic decreases consequences of abuse and misuse. It is expected to be available before the end of 2011.
Rivaroxaban has been FDA approved for the prevention of deep vein thrombosis in patients undergoing hip or knee replacement surgery.8 It is currently the only new oral anticoagulant for venous thromboembolism prophylaxis in patients undergoing knee or hip replacement surgery. In clinical trials, rivaroxaban was more effective than enoxaparin and placebo, with a similar safety profile compared to enoxaparin as well as lower major bleeding rates. Approval is also being sought for stroke prevention in AF.