On 12 March 2010, Orexigen entered into an exclusive manufacturing agreement with Patheon for the development of Contrave and future formulations of Orexigen products. Takeda plans to launch Contrave in the North American market in Fall 2014 and in the European market in early 2015. In September 2010, Orexigen sold the US, Mexico and Canada marketing rights of the experimental Contrave drug to Japan-based company Takeda Pharmaceutical for $50m. The marketing authorisation in Europe will be based on the outcome of the LIGHT study. The primary endpoint of the study is to evaluate the rate of major adverse cardiovascular events in overweight and obese adults with cardiovascular risk factors and receiving Contrave.
FREE CLINICAL TRIALS FOR WEIGHT LOSS TRIAL
The clinical trial programme also includes an ongoing study called LIGHT, which is a double-blind, placebo-controlled cardiovascular study that has enrolled 8,900 patients. The results of the four studies showed that non-diabetics treated with Contrave showed an average weight loss of 4.1% over treatment with placebo at one year. The studies were conducted on 4,536 patients who were randomised to Contrave or placebo to evaluate the effectiveness of Contrave for one year. The FDA approval for the Contrave was based on the results obtained from four Phase III clinical trials named COR-I, COR-II, COR-BMOD and COR-Diabetes. The results showed a 7.5% weight loss compared to just 2.5% weight loss observed in the placebo-administered patient group.ĭata from the Ambulatory Blood Pressure Monitoring sub-study also showed weight loss and improvements in markers of cardiometabolic risk.
It was observed that the patients maintained a normal circadian pattern of blood pressure variation over one year of the treatment. The results of the trial were released in April 2011. In December 2007, Orexigen started COR-II Phase III clinical trial which is a 56-week study designed to assess the safety and efficacy of Contrave. The results from the COR-I trials showed that the drug has made significant improvements over placebo in insulin resistance, HDL cholesterol and cardiometabolic risk. The key objective of COR (Contrave Obesity Research) was to evaluate the impact of weight loss on markers of cardiovascular and metabolic risk. The study showed that the patients who were administered with Contrave have lost body weight up to 5% to 10% when compared with placebo on both completers and intent-to-treat basis. In July 2010, the company revealed the results from its 58-week COR-I Phase III trials. In October 2007, Orexigen started COR-I Phase III clinical trial on Contrave to assess its safety and efficacy in healthy, nondiabetic, obese patients. "Contrave is an anti-obesity drug which reduces appetite or inhibits fat absorption." The study was initiated in 51 centres and enrolled 505 patients. In May 2007, a COR-Diabetes Phase III clinical trial focused on assessing the safety and efficacy of Contrave in obese subjects who also have been diagnosed with Type II diabetes. This trial enrolled 800 patients across nine centres. In April 2007, the company initiated a 56-week COR-BMOD Phase III clinical trial to evaluate the safety and efficacy of Contrave alone. Orexigen has initiated four Phase III clinical trials on Contrave for the treatment of obesity. The study enrolled 410 patients with the purpose of determining the safety and efficacy of the drug by using three different combinations of the drugs such with different doses and a placebo.
Orexigen conducted Phase II clinical trials on Contrave from April 2005 to March 2007.
The drug is available in tablet form for oral administration. The drug was tested with different combinations but the most effective combination so far has been 360mg of bupropion with 32mg of naltrexone.Ĭontrave is an anti-obesity drug which reduces appetite or inhibits fat absorption. The two drugs used in Contrave combination are Bupropion, which is used for smoking cessation, and naltrexone, which is used against drug addictions.
"Contrave is a combination of two previously approved drugs for other ailments." Contrave’s mechanism of actionĬontrave is a combination of two previously approved drugs for other ailments.
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