After numerous rejections, large pharmas have shied away from anti-obesity R&D. The FDA has not approved a new prescription anti-obesity drug since 1999 when it opened the U.S. market to Roche's Xenical.
Yet at least three smaller U.S. biopharmaceutical companies have new anti-obesity drugs in clinical trials or are awaiting FDA approval in 2011.
Qnexa, a formulation of low dose phentermine and topiramate developed by Vivus Pharmaceuticals, has been responding to FDA inquiries into safety as part of its application process. The company is making "continued progress" toward approval, according to Vivus CEO Leland Wilson.
FDA panels responded more positively to Orexigen Therapeutics' Contrave (bupropion SR and naltrexone SR) trial data. The agency continues its reviews and the company hopes for an early 2011 approval.
Orexigen's Empatic (zonisamide SR/bupropion SR) and Alizyme's Cetilistat, are in clinical trials. Both Orexigen Therapeutics and Alizyme have partnered with Japan's Takeda Pharmaceuticals on their drug discoveries.
One large company, Denmark's Novo Nordisk, is in early U.S. trials of its weight-loss medication -- compound '2-0453 -- on obese men and women.
Sources:
"Obesity and the Economics of Prevention: Fit not Fat - United States Key Facts."
Organisation for European Economic Cooperation (OEEC).
http://www.oecd.org/document/57/0,3343,en_2649_33929_46038969_1_1_1_1,00.html
Accessed: December 18, 2010.
"Anti-Obesity - Drug Pipeline Analysis and Market Forecasts to 2016."
GlobalData Press Release, January 10, 2010. Accessed: December 18, 2010.
http://tinyurl.com/2aklvns
World Health Organization: Obesity and Overweight
Accessed: December 18, 2010. http://www.who.int/hpr/NPH/docs/gs_obesity.pdf
"Anti-Obesity - Drug Pipeline Analysis and Market Forecasts to 2016,"
GlobalData Press Release, January 10, 2010. Accessed: December 18, 2010.
http://tinyurl.com/2aklvns
David S. Weigle, "Pharmacological Therapy of Obesity: Past, Present, and Future."
The Journal of Clinical Endocrinology & Metabolism Vol. 88, No. 6 2462-2469.
Accessed: December 18, 2010. http://jcem.endojournals.org/cgi/content/full/88/6/2462
