Drug Topics - January 2009 - (Page 27) NEW DRUGS Respiratory agents Respiratory drug development is focused on a wide range of potential combination therapies and will not see a new class of drugs for at least 3 to 5 years. With the (device) patent for fluticasone/salmeterol (Advair; GlaxoSmithKline) facing expiration in 2011, the company is now working on a once-daily formula. Novartis is developing indacaterol (Alacra; Skye- Pharma) an ultra-long-acting beta2 agonist inhaler, as monotherapy for chronic obstructive pulmonary disease (COPD) and combination therapy for asthma. NDA filing for aclidinium (Forest/Almirall), an inhaled muscarinic antagonist for COPD, is planned for 4Q 2009 or 1Q 2010. Tadalafil (Cialis; Lilly) is being evaluated for the treatment of pulmonary hypertension. Treprostinil (Viveta; United Therapeutics), a portable nebulizer formulation of Remodulin (also United Therapeutics), is also being evaluated. Pfizer is awaiting FDA approval for sitaxsentan (Thelin), an endothelin receptor antagonist for pulmonary arterial hypertension treatment. Diabetes treatments Only 7 percent of patients with diabetes achieve their target goals for blood glucose, cholesterol, and blood pressure, and many of these patients are under treated. Drugs in the pipeline are being developed to meet the needs of this population as the incidence of diabetes assumes epidemic proportions. Two new dipeptidyl peptidase (DPP-4) products, alogliptin (SYR-322; Takeda) and saxagliptin (Onglyza; Bristol-Myers Squibb/AstraZeneca), are completing phase 3 trials. Novo Nordisk submitted an NDA for liraglutide, a GLP-1 analog on May 23, 2008. Dapagliflozin (BMS/Astra-Zeneca), a highly selective inhibitor of sodium glucose co-transporter 2 (SGLT2), has a dose-dependent effect on HbA1c levels and fasting plasma glucose (FPG). In clinical trials the drug produced slight weight loss but was also associated with a higher incidence of urinary tract infections. MannKind is hoping to gain approval for a delivery system that administers a dry-powder insulin formulation through a palm-sized inhaler. Phase 3 trial data comparing this powder formulation with injected insulin have suggested similar efficacy. Editor’s note: The clinical information provided in this article is as current as possible. Due to regularly emerging data on developmental or newly approved drug therapies, this article included information published or presented and available up until press time. http://www.nasinetwork.com http://www.nasinetwork.com
Table of Contents Feed for the Digital Edition of Drug Topics - January 2009 Drug Topics - January 2009 Contents Letters Up Front Up Front in Depth Community Practice Drug Pipeline: What to Watch in 2009 OTC Community-Aquired MRSA Infections New Products Viewpoint Drug Topics - January 2009 Drug Topics - January 2009 - Drug Topics - January 2009 (Page Cover1) Drug Topics - January 2009 - Drug Topics - January 2009 (Page Cover2) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 1) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 2) Drug Topics - January 2009 - Drug Topics - January 2009 (Page 3) Drug Topics - January 2009 - Contents (Page 4) Drug Topics - January 2009 - Contents (Page 5) Drug Topics - January 2009 - Contents (Page 6) Drug Topics - January 2009 - Contents (Page 7) Drug Topics - January 2009 - Contents (Page 8) Drug Topics - January 2009 - Contents (Page 9) Drug Topics - January 2009 - Contents (Page 10) Drug Topics - January 2009 - Contents (Page 11) Drug Topics - January 2009 - Letters (Page 12) Drug Topics - January 2009 - Letters (Page H1) Drug Topics - January 2009 - Letters (Page H2) Drug Topics - January 2009 - Letters (Page H3) Drug Topics - January 2009 - Letters (Page H4) Drug Topics - January 2009 - Letters (Page H5) Drug Topics - January 2009 - Letters (Page H6) Drug Topics - January 2009 - Letters (Page H7) Drug Topics - January 2009 - Letters (Page H8) Drug Topics - January 2009 - Letters (Page 13) Drug Topics - January 2009 - Up Front (Page 14) Drug Topics - January 2009 - Up Front (Page 15) Drug Topics - January 2009 - Up Front (Page 16) Drug Topics - January 2009 - Up Front (Page 17) Drug Topics - January 2009 - Up Front in Depth (Page 18) Drug Topics - January 2009 - Up Front in Depth (Page 19) Drug Topics - January 2009 - Community Practice (Page 20) Drug Topics - January 2009 - Community Practice (Page 20a) Drug Topics - January 2009 - Community Practice (Page 20b) Drug Topics - January 2009 - Community Practice (Page 21) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 22) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 23) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 24) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 25) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 26) Drug Topics - January 2009 - Drug Pipeline: What to Watch in 2009 (Page 27) Drug Topics - January 2009 - OTC (Page 28) Drug Topics - January 2009 - OTC (Page 29) Drug Topics - January 2009 - OTC (Page 30) Drug Topics - January 2009 - OTC (Page 31) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 32) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 33) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 34) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 35) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 36) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 37) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 38) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 39) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 40) Drug Topics - January 2009 - Community-Aquired MRSA Infections (Page 41) Drug Topics - January 2009 - New Products (Page 42) Drug Topics - January 2009 - New Products (Page 43) Drug Topics - January 2009 - New Products (Page 44) Drug Topics - January 2009 - New Products (Page 45) Drug Topics - January 2009 - New Products (Page 46) Drug Topics - January 2009 - New Products (Page 47) Drug Topics - January 2009 - Viewpoint (Page 48) Drug Topics - January 2009 - Viewpoint (Page Cover3) Drug Topics - January 2009 - Viewpoint (Page Cover4)
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