FDA approved orexigen / Takeda weight loss drug contract

According to the announcement, the drug is intended for adults with a BMI of more than 30 or an BMI of more than 27 with high blood pressure, type II diabetes or high cholesterol The contract clinical trial conducted by orexigen therapeutics Inc involved 4500 patients for one year The results showed that all patients who used contract lost 4.1% of their body weight after one year, 42% of them lost at least 5% of their body weight, far more than 17% of placebo patients The U.S FDA also issued a black box warning that doctors should be aware of the increased risk of suicide due to the presence of bupropion in contract In addition, patients with spasticity and hypertension should not use contract products
FDA Approves Co ntrave Weight Loss Drug From Orexigen And Takeda The FDA announced today that it had approved Contrave, the long-awaited and much-disputed weight loss drug  The drug is a combination of two drugs already approved for other indications: naltrexone hydrochloride, which is used to combat alcohol and opioid dependence, and bupropion, which is used to treat depression and seaso nal affective disorder and as an aid to smoking cessation treatment Co ntrave is manufactured by Orexigen and will be distributed by Takeda The FDA said that Co ntrave had been approved for use in obese adults (BMI of 30 or over) or overweight adults (BMI of 27 or over) with at least one weight-related co ndition such as high blood pressure, type 2 diabetes, or elevated cholesterol The  approval comes several years after the approval in 2012 of two competing weight loss drugs,  Arena’s Belviq and Vivus’s Qsymia Neither drug has achieved much success in the marketplace Orexigen had originally hoped for an even earlier approval but it’s hopes were dashed in 2011 when the FDA demanded that the company perform a safety study In one clinical trial significant weight loss– defined as the loss of at least 5% of body weight– was achieved by 42% of people who received Co ntrave  and 17% of people who received placebo In a trial of people with type 2 diabetes 36% of patients taking Co ntrave and 18% of patients taking placebo had a significant weight loss of at least 5% of body weight The FDA said that people taking Co ntrave should be e valuated after 12 weeks of treatment Patients who have failed to lose at least 5% of their body weight should disco ntinue the drug
Because Co ntrave co ntains buproprion, the label will include a boxed warning a lerting physicians and patients to the increased risk of of suicidal thoughts and behaviors associated with antidepressant drugs The drug can also cause seizures and is co ntraindicated in people with seizure disorders Co ntrave has also been found to increase blood pressure and should not be used in people with unco ntrolled hypertension The FDA is requiring Orexigen to perform a cardiovascular outcomes trial and two safety and efficacy trials in pediatric populations.