Buprenorphine BioErodible MucoAdhesive (BEMA) will soon be in phase III clinical trials as a treatment for moderate to severe chronic pain.19 The BEMA formulation delivers the medication through a dissolvable patch that is applied inside the cheek. If patient enrollment goes as planned, the NDA may be filed in the beginning of 2012.
Epratuzumab in combination with immunosuppressants is undergoing phase II clinical trials for the treatment of SLE. Epratuzumab is a humanized anti-CD22 monoclonal antibody.20
Filgrastim injection (Neupogen) is FDA approved to treat neutropenia.21 Teva has applied for a generic version of this agent, and the FDA has issued a complete response letter. The letter states that no additional clinical trials are necessary, but several items were called into question. The proposed brand name is Neutroval. It has been available in the European Union since September 2008 under the brand name TevaGrastim. If approved, Amgen patents on the innovator product are set to expire in 2013.
Golimumab (Simponi) has had its NDA filed for treating patients with active psoriatic arthritis.22 Johnson & Johnson is hoping to gain approval for the indication of inhibiting the progression of structural damage and maintaining improvement in the signs and symptoms of psoriatic arthritis and improvements in physical functioning in patients with the disease.
Tasocitinib, an investigational oral JAK inhibitor, is currently undergoing phase III clinical trials as a monotherapy treatment to reduce the signs and symptoms of rheumatoid arthritis.23 Two of three primary endpoints were met in a recent study at the end of three months of treatment.
Tiagabine hydrochloride tablets (Gabitril) have had a REMS approved to inform patients about the increased risk of suicidal behavior and thoughts associated with this class of antiepileptic agents.24 The current label already contains a warning including this risk. The REMS is in the form of a medication guide.
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Safety
Leflunomide tablets (Arava) have had changes to their boxed warning and warnings sections of the safety label. The changes relate to liver function test (LFT) abnormalities.25 The boxed warnings and a new hepatotoxicity warning state that if alanine amino transferase (ALT) increases above three times the upper limit of normal, then leflunomide should be discontinued, and the cause of the ALT elevation should be evaluated. If the elevation is likely related to leflunomide, then use of the cholestyramine washout should be started with weekly LFT testing until the tests have normalized. If liver injury is unlikely due to the agent, than therapy can be resumed.