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(This story has been revised to indicate that Belvic is the first of three new weight-loss drugs, the second to hit the market).
Diet Pills Contrave
San Diego-based Orexigen’s long-awaited and controversial weight-loss drug Contrav has been approved by the U.S. Food and Drug Administration, the U.S. Food and Drug Administration announced Wednesday.
The Weight May Be Over: New Diet Drug Approved
The drug is bupropion, which is included in the antidepressant Wellbutrin. and naltrexone; An opioid blocker used to stop alcohol and opioid addiction.
Contrav, the third weight-loss drug approved by the FDA in recent years, has long been shelved because of phen-phen weight-loss deaths.
Mountain View-based Vivus’ first Qsymia went on sale in September 2012. A second Belviq, manufactured by San Diego’s Arena Pharmaceuticals, went on sale in June 2013. Belviq was actually approved before Qsymia. However, Belvic’s sale was delayed until the Drug Abuse Administration rated it for abuse potential.
For years, the three companies competed in a horse race to get the first permit. But Vivas didn’t enjoy the marketing boost it first received with its approval. Qsymia and Belviq did not generate particularly strong sales. This makes Orexigen’s subsequent approval less of a hurdle. Instead, Companies face the same problem: convincing doctors and patients that drugs are worth trying.
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Contrave was rejected by the FDA in 2011, which said it was concerned about the drug’s cardiovascular risks. Belvic and Cusmia were rejected in 2010 before the FDA finally granted approval after Orexigen completed the additional safety studies it did for Contra.
Further trials of the “fen-phen” scare emerged in the late 1990s among users of Fen-phen’s combination of the appetite suppressants fenfluramine and phentermine, causing heart-related deaths and injuries.
But as the obesity epidemic continues, the FDA has reassessed the situation, deciding that not allowing new drugs on the market could also be dangerous.
About 79 million American adults were obese in 2008, worth $147 billion, according to the Centers for Disease Control and Prevention. About 12.7 million children and adolescents between the ages of 2 and 19 are obese.
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“Obesity continues to be a major public health concern,” Dr. Jean-Marc Guettier of the FDA’s Center for Drug Evaluation and Research said in an agency statement. “When used in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrav provides an alternative option for chronic weight management for people who are overweight or obese.”
Contrav has been studied in several clinical trials involving approximately 4,500 overweight and obese patients. All patients were placed on a reduced calorie diet and moderate physical activity.
Patients without diabetes lost an average of 4.1 percent more weight than those treated with placebo, measured at one year.
In this trial, 42 percent of patients given Contrav lost at least 5 percent of their body weight, compared with 17 percent of patients treated with placebo. Another clinical trial in type 2 diabetes patients found that patients given Contrav lost 2 percent more of their body weight than those given a placebo over a year. In addition, 36 percent of patients treated with Contrav lost at least 5 percent of their weight, compared with 18 percent of patients given placebo.
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Patients using the drug should be evaluated after 12 weeks to determine if the treatment is working, the FDA said in a statement. If the patient does not lose at least 5 percent of baseline weight during that time, Contrav should be discontinued because the patient is unlikely to achieve and maintain meaningful weight loss, the agency said.
The drug is bupropion; There are warnings associated with antidepressants that may increase the risk of suicidal thoughts and seizures. Contrave also carries the risk of raising blood pressure and is not approved for patients with uncontrolled high blood pressure, the FDA said.
Adding Contrav to the list of weight-loss drugs is good for patients and good for Arena, said Craig Audet, Arena’s senior vice president of operations. Patients who do not benefit from one drug may benefit from another; That’s why interest in options should grow, Audet says. Audette said only a small percentage of people who could benefit from drugs are using them.
Wells Fargo & Co. Contrav’s U.S. sales could total $634 million by 2020, analyst Matthew Andrews said in a report.
Anti Obesity Medication
Government programs such as Medicare and Medicaid do not pay for weight-loss drugs; About 50 percent of those with private insurance have coverage for diet pills, Piper Jaffray analyst Charles Duncan said in a telephone interview.
Many insurers cover the third tier of drugs they cover, meaning patients pay large amounts out of pocket. Orexigen’s addition of drugs could expand coverage, Duncan said.
Belvic covers more than 60 percent of them with private insurance, Audet said in an email. Arena’s marketing partner, Japan’s Isai, said it aims to reach 70 percent coverage by the end of March 2015.
Eisai launched a national television advertising campaign for Belviq in mid-April, and the number of prescriptions filled in the second quarter of this year totaled more than 110,000, a 43 percent increase from the previous quarter, he said.
Contrave Product Training
Andrews said Belvic is expected to generate $808 million in U.S. obesity sales by 2020. Eisai reported drug sales of $25 million for the year ended March 31.
Orexigen is also pursuing the drug as a diabetes treatment, which could boost sales to $1.2 billion by 2020, Andrews said.
Three weight loss pills are not on the European market. Orexigen’s drug became the first to be sold in 2015. Suicidal thoughts or actions: One of its ingredients is bupropion. Bupropion can cause suicidal thoughts or unusual changes in behavior or behavior in some people, whether or not they are taking medications used to treat depression. Bupropion may be used in children, adolescents, and adults during the first few months of treatment. It may increase the risk of suicidal thoughts or actions in teenagers and young adults. If you have depression or other mental illnesses; Bupropion may make things worse, especially during the first few months of treatment.
A weight loss drug that may help some adults with a body mass index (BMI) of 30 kg/m
Fda Approves New Weight Loss Pill
Or high blood pressure; high cholesterol or have at least one weight-related medical problem, such as type 2 diabetes (obesity); Lose weight and avoid.
While ordering, You or your family members make changes; especially sudden changes; state of mind behavior Thoughts or feelings should be paid attention to. This is especially important when starting medication or when your dose changes.
Especially if you or your family members notice any of the following symptoms: Especially if they are new, worse or if you have anxiety – thoughts of suicide or death; attempted suicide; depression; Anxiety, tremors, or restlessness; panic attacks; itching; aggression anger or violence; acting on dangerous emotions; extreme increase in movement and speech; other unusual changes in behavior or mood; Sleep problems
Do not take if you have uncontrolled high blood pressure. Those who attended WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, Use other medicines that contain bupropion, such as APLENZIN and ZYBAN. have or have had an eating disorder called anorexia or bulimia; being dependent on opioid pain relievers or using medications to help stop opioid use; After drinking a lot of alcohol, suddenly stop drinking. or use sedatives (they make you sleepy); suddenly stop using benzodiazepines or anticonvulsants; taking medicines called monoamine oxidase inhibitors (MAOIs) in the past 14 days; or allergic to any ingredient.
Contrave Review (update: 2021)
Tell your healthcare provider about all medical conditions you have, including depression or other mental illnesses. suicide attempt; convulsions; head injury; brain or spinal cord tumors or infections; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack heart problems or stroke; eating disorders drink a lot of alcohol; prescription drug or street drug abuse; 65 or older; diabetes; pregnant or planning to become pregnant; or breastfeeding.
Its most common side effects are nausea; Constipation headache Vomiting dizziness Insomnia Includes dry mouth and diarrhea. These are not all possible side effects.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
It’s not known whether it changes your risk of heart problems or stroke or death from heart problems or stroke.
What You Need To Know About The New Weight Loss Medication Contrave
It is not known whether it is safe.
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