Curr Opin Invest Dr
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Curr Opin Invest Dr · Aug 2002
ReviewAntithrombotic drugs for the treatment of heparin-induced thrombocytopenia.
Because patients with heparin-induced thrombocytopenia (HIT) have an extremely high frequency of developing thrombosis, treatment options other than heparin are essential. Prophylaxis against thrombosis should also be considered. The current American College of Chest Physicians guidelines for the treatment of acute heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) include the use of danaparoid, lepirudin or argatroban, alone or in combination with warfarin. ⋯ HIT patients, in addition to needing anticoagulation to treat thrombosis, can require anticoagulation for non HIT-related events, such as for the treatment of myocardial infarction, unstable angina and long-term anticoagulation for heart valves or atrial fibrillation. For these situations, and if immediate anticoagulation is needed, the use of a direct thrombin inhibitor with switch-over to warfarin is a useful option. However, optimal dosing regimens have not been established in all cases.
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Inhale, in colaboration with Pfizer and Aventis Pharma (formerly Hoechst Marion Roussel; HMR), is developing an insulin formulation utilizing its pulmonary delivery technology for macromolecules for the potential treatment of type I and II diabetes. By July 2001, the phase III program had been completed and the companies had begun to assemble data for MAA and NDA filings; however, it was already clear at this time that additional data might be required for filing. By December 2001, it had been decided that the NDA should include an increased level of controlled, long-term pulmonary safety data in diabetic patients and a major study was planned to be completed in 2002, with the NDA filed thereafter (during 2002). ⋯ At this time, analysts at Credit Suisse predicted a launch of the product in 2003, with sales of $70 million in that year, rising to $550 million in 2005. By October 2001, Deutsche Bank predicted sales of $50 million in 2004 and $250 million in 2005. In September 2001, Morgan Stanley predicted sales of $500 million in 2002, rising to $1250 million in 2006.
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Thymosin alpha1 (Talpha1), a synthetic 28-amino acid peptide with multiple biological activities primarily directed towards immune response enhancement, was originally developed by Alpha 1 Biomedicals for the treatment of hepatitis B virus (HBV) infection. SciClone developed and launched Talpha1, under the trade name Zadaxin, for the treatment of HBV and hepatitis C virus (HCV) infections. The drug is also being developed for the treatment of non-small cell lung cancer (NSCLC), hepatocellular carcinoma, AIDS and malignant melanoma. ⋯ In August 2001, SciClone received a notice of allowance for patent protection in Japan covering the use of Talpha1. The patent, which extends until 2012, also covers the use of Talpha1 in combination with interferon-alpha for the treatment of HCV infection. SciClone was previously granted a Japanese patent for the use of Talpha1 in the treatment of HBV infection.
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Progenics is developing methylnaltrexone (MNTX), an opioid antagonist licensed from UR Labs and the University of Chicago, for the potential treatment of the side effects of opioid pain therapy, such as constipation and post-operative bowel dysfunction. MNTX was discovered at the University of Chicago and subsequently licensed by UR Labs. In October 2001, Progenics entered into an agreement with UR Labs to obtain exclusive worldwide rights to the drug [423791]. ⋯ In October 2001, a double-blind, randomized, phase II study evaluating sc MNTX in cancer patients for the treatment of opioid-induced constipation was initiated at the University of Chicago Medical Center [423791]. In December 2001, the company stated that it was preparing to initiate phase IIb trials of the compound in opioid-induced constipation and post-operative bowel dysfunction [423791], [432507]. These trials were initiated in February 2002 [440995].
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Neuropathic pain results from damage to the nervous system due to many diverse processes. It causes persistent, distressing pain that is reputedly unresponsive to conventional analgesics. ⋯ There is no single effective drug treatment and patients have been empirically treated with antidepressants and antiepileptics in the past. This review focuses on evidence from randomized controlled trials to assess the efficacy of the currently available drug treatments.