Lorcaserin in the treatment of cocaine use disorder the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Initially, fda considered lorcaserin as a low risk for adverse events, in view of its specificity for binding to 5ht2c and low potency binding to 5ht2b. Health care professionals should stop prescribing and dispensing lorcaserin to patients. The fda approved lorcaserin belviq lorcaserin hcl buy belviq. Lorcaserin is one of the last three drugs approved by the fda to treat adult people who are really suffering from excess fat.
Your requirements under prea for pmrs 19003 and 19004, as stated in the approval letter for nda 022529 for belviq lorcaserin hydrochloride tablets, 10 mg, dated june 27, 2012, also apply to nda 208524 for belviq xr lorcaserin hydrochloride extended release tablets, 20 mg. Fda issues complete response letter for lorcaserin new. The effect of lorcaserin in geriatric populations is unknown, as most patients in the three published clinical trials were 65 years of age or younger. Persons with disabilities having problems accessing the pdf files below may call 301. Side effects have been the key issue for antiobesity drugs previously withdrawn from the market. The fda approved lorcaserin belviq lorcaserin hcl buy. It reduces appetite by activating a type of serotonin receptor known as the 5ht 2c receptor in a region of the brain called the hypothalamus, which is known to control appetite. Lorcaserin was initially rejected in october 2010 concerning cancer signals detected in animal studies. Study synopsis and perspective the second trip before the food and drug administration appears to have done the trick.
They are indicated as an adjunct to a reducedcalorie diet and. Demonstrate significant weight loss, in the initial 12. Fda issues complete response letter for lorcaserin new drug. Dose adjustment is not required in mild renal impairment. Lorcaserin belviq national drug monograph june 20 va pharmacy benefits management services, medical advisory panel, and visn pharmacist executives. Health care professionals should stop prescribing and dispensing lorcaserin. Review of submitted epidemiologic analyses of lorcaserin abuse. The recommended dose of belviq is 10 mg administered orally twice daily. Lorcaserin, marketed under the brand name belviq is a weightloss drug developed by arena pharmaceuticals. Describe the staged implementation schedule for the. The use of lorcaserin in patients with severe renal impairment or endstage renal failure is not recommended.
The effect of lorcaserin on cardiovascular morbidity and mortality has not been established. Arena will meet with the fda to obtain further clarity on the approval path and timeline. Lorcaserin hcl was approved by the food and drug administration fda on june 27, 2012, as an addition to a reducedcalorie diet and exercise, for chronic weight management and it will be marketed under the trade name belviqsupreg. Unlike to the food and drug administration fda approved lorcaserin as an obesity treatment, european medicines agency ema believes that lorcaserin advantages do not exceed it potential risks. These documents will be updated when new clinical data warrant additional. Lorcaserin belviq is a selective serotonin 2c agonist labeled for chronic weight management in adults who are obese body mass index bmi.
The fda has approved lorcaserin for chronic weight loss management in adults as an adjunct to diet and exercise. Lorcaserin dosage does not depend on the age and sex of patients. Lorcaserin in the treatment of cocaine use disorder full. Find patient medical information for lorcaserin oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. A total of 604 patients were enrolled and were randomly assigned, in a 1. Describe the history of the drug labeling initiative. Fda approved indications belviq and belviq xr are indicated as an adjunct to a reducedcalorie diet and increased.
No dose adjustment of belviqbelviq xr is required in patients with mild renal impairment. Belviq lorcaserin is a serotonin 2c receptor agonist indicated for chronic weight management in adults who are obese, or overweight and who have at least one weightrelated condition such as high blood pressure, type 2 diabetes, or high cholesterol. Do not start, stop, or change the dose of any drug without checking with your doctor. Very few drugs are available for treatment of obesity, last drug approved by food and drug administration fda in 1999 was orlistat, after years a new prescription drug lorcaserin was approved in june 2012 by the fda. Lorcaserin hcl was approved by the food and drug administration fda on june 27, 2012, as an addition to a reducedcalorie diet and exercise, for chronic weight management and it will be marketed under the trade name belviq. The webpage contains the most recent drug safety communications from fda as. Lorcaserin is effective for weight loss in obese patients with and without type 2 diabetes, although its specific role in the management of obesity is unclear at this time. The phase ii and phase iii studies of lorcaserin for the treatment of obesity indicate weight loss both alone and in combination with a lifestyle modification targeting a 600 kcalday caloric deficit program. This is an important step for us toward the fda s approval of lorcaserin, said jack lief, arenas president and chief executive officer.
If you want to discuss an alternative approach, contact the office of generic drugs. Lorcaserin can be used throughout a day before, during or with meals. It was approved by the fda in 2012 for weight management in conjunction with lifestyle modification and has been marketed in the us as belviq. Lorcaserin lorcaserin, a selective serotonin 2c agonist thought to decrease appetite and increase satiety, was approved by the fda in june 2012 for adults with a bmi of 30 kgm2 or greater or with a bmi of 27. Lorcaserin is an fda approved medication for weight management in overweight or obese patients which also provides a noticeable benefit in treating drug dependence. Fdas analysis compared lorcaserin, which targets 5ht2c in the brain, with fenfluramine, which targets 5ht2b. Lorcaserin is a serotonin receptor agonist, at the 5ht2c and 5ht2a receptor subtypes. Belviq xr lorcaserin hydrochloride extendedrelease tablets fda. The original nda submission included two sets of studies which addressed the binding affinity and receptor activation kinetics for lorcaserin against the human 5ht2a, 2b, and 2c receptors. Refer to the offlabel use policy for the relevant line of business if diagnosis is not specifically listed under section iii diagnosesindications for which coverage is.
The development of pharmacotherapy for the management of obesity is still at the infancy stage. Portable document format specifications food and drug. Federal register schedules of controlled substances. Belviq is tablets containing 10mg of active substance, called lorcaserin hydrochloride. The panel of experts voted 9 to 5 to urge the fda not to approve lorcaserin. Draft guidance on lorcaserin hydrochloride recommended mar 2015 this draft guidance, once finalized, will represent the food and drug administration s fdas current thinking on this topic. The effect of belviq on cardiovascular morbidity and mortality has not been established. Placement of lorcaserin into schedule iv on december 19, 2012. Lorcaserin belviq is a drug that promotes weight loss by affecting the brains hypothalamus. Belviq lorcaserin hydrochloride tablets, for oral use, civ. Welcome to lecom point, a drug information source that is direct and to the point special topics. While the complete response letter provides us with. Lorcaserin belviq, belviq xr is a serotonin 2c receptor agonist. A bmi chart for height in inches and weight in pounds is provided below.
Belviq lorcaserin hydrochloride dose, indications, adverse. The drug may be used in this setting in patients with a bmi of more than 30 kgm 2 or a bmi of more than 27 kgm 2 in the presence of 1 or more weightrelated comorbidities such as hypertension, dyslipidemia, or type 2 diabetes. Lorcaserin must be used along with a reduced calorie diet and an exercise plan. No dose adjustment of belviq is required in patients with. You can use an alternative approach if the approach satisfies the requirements. This drug is lorcaserin, which was discovered and developed by arena pharmaceuticals. What are some things i need to know or do while i take lorcaserin tablets. Cardiovascular safety of lorcaserin in overweight or obese. Belviq is indicated as an adjunct to a reducedcalorie diet and increased physical activity for chronic weight. Serotonin receptor selectivity profile of lorcaserin background. Lorcaserin is a selective serotonin agonist that is approved as a weight loss agent. Do not breastfeed while you take this medicine lorcaserin tablets. Phentermine and fenfluramine, components of the weight loss combination.
The use of lorcaserin in the management of obesity. The purpose of va pbm services drug monographs is to provide a comprehensive drug. Analyzing the results of clinical trials, ema paid attention to the fact that longterm use of lorcaserin. The new drug, lorcaserin, is made by arena pharmaceuticals and claims to control appetite through receptors in the brain. To reduce the food intake, it is recommended to take 1 belviq pill twice daily. Approval of this submission by fda is not required before the labeling is used. Many drug companies are pursuing pharmacological treatments because of the rising incidence of obesity, which affects more than 35% of u. This draft guidance, when finalized, will represent the.
In this trial of 12,000 participants over 5 years, more patients taking lorcaserin. Lorcaserin was previously shown to be efficacious for weight loss, which led to approval by the fda for longterm weight management in obese or overweight patients who had at least one weight. About lorcaserin nda new drug application the lorcaserin new drug application is based on a data package from lorcaserin s development program that includes 18 clinical trials totaling 8,576 patients. Draft guidance on lorcaserin hydrochloride food and drug. Medwatch the fda safety information and adverse event reporting program. Jun 27, 2012 fda approval history for belviq lorcaserin used to treat obesity. Lorcaserin is a novel drug acting selectively as a 5ht 2c receptor agonist in the hypothalamus with a functional selectivity of 15 times higher affinity for 5ht 2c than for 5ht 2a.
Drug therapy guidelines appetite suppressants anorexiants. Lorcaserin belviq for weight loss steps american family. Lorcaserin belviq is indicated for peroral use with a glassful of water. Elderly patients with normal renal function should require no dose adjustment. This draft guidance, when finalized, will represent the current thinking of the food and drug administration fda, or the agency on this topic. Lorcaserin approved for weight loss the food and drug administration recently approved the first drug for weight loss in more than ten years. Dec 15, 2014 lorcaserin belviq is a selective serotonin 2c agonist labeled for chronic weight management in adults who are obese body mass index bmi. It is the policy of health plans affiliated with envolve pharmacy solutions that belviq and belviq xr are medically necessary. Clinical trials involving patients over 65 years old did not reveal the need to change the dosage based only on the patients age. Documents in pdf format require the adobe acrobat reader. Lorcaserin will be marketed by arena pharmaceuticals as the brand name, belviq.
In october 2010, the fda rejected lorcaserin because of concerns about a cancer signal detected in preclinical animal studies and asked for more data, including results from the bloomdm trial, a. For more information, see fda drug safety communication. Your fda gateway for clinically important safety information and reporting serious problems with human medical products. Do not exceed recommended dose see warnings and precautions 5. Bmi is calculated by dividing weight in kg by height in meters squared.
It is the policy of health plans affiliated with envolve pharmacy solutions that belviq and belviq. Nov 01, 2011 the manufacturer of lorcaserin is pursuing fda approval of the drug in 10mg tablets. Fda briefing document nda 22529 lorcaserin hydrochloride. This new drug application provides for the use of belviq xr lorcaserin hydrochloride extendedrelease. State medical board of ohio state of ohio medical board. The pivotal phase iii clinical trial program, bloom behavioral modification and lorcaserin. Persons with disabilities having problems accessing the pdf. Pdf type 2 diabetes and obesity commonly occur together. Requirements to use preferred alternative agents apply only when such requirements align with the health plan approved formulary. In the midst of controversy over the weight loss drug qnexa, a new drug has entered the arena of consideration after it was approved by an fda advisory panel on thursday. A month ago, vivus said that the fda had pushed back its target date.
Belviq xr lorcaserin hydrochloride extendedrelease tablets. May 08, 2012 the fda has posted briefing documents for thursdays meeting of the endocrinologic and metabolic drugs advisory committee to reconsider the new drug application for lorcaserin lorqess, arena. Lorcaserin is a prescription medication used to help adults who are obese or who are overweight and have weightrelated medical problems to lose weight and keep from gaining back that weight. Panel advises fda to approve lorcaserin obesity pill cbs news. May 11, 2012 if the fda agrees with the panels recommendation, lorcaserin could be the first obesity pill of the trio to hit the market. However, only one such drug has been approved for clinical use. Side effects, drug interactions, and use during pregnancy. Department of health and human services silver spring md 20993. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Accordingly, your requirements under prea are as follows. In clinical trials, participants taking lorcaserin lost only 3. To discuss an alternative approach, contact the office of generic drugs. Lorcaserin has been in clinical use for a short time only, but has not been linked to serum enzyme elevations during therapy or to instances of clinically apparent liver injury.
It is an important step for arena and eisai toward the fdas approval of lorcaserin. Tell all of your health care providers that you take this medicine lorcaserin. The fda approved lorcaserin lorcaserin is one of the last three drugs approved by the fda to treat adult people who are really suffering from excess fat. No dose adjustment of belviq xr is required in patients. In july 2011, martin shkreli sent crew a powerpoint presentation on arena arna pharmaceuticals weight loss drug lorcaserin that he had also sent to the fda. Food and drug administration fda reports that safety data from a lorcaserin clinical trial shows a possible increased risk of cancer. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind fda or the public. On 27 june 2012, the fda officially approved lorcaserin for use in the treatment of obesity for adults with a bmi equal to or greater than 30 or adults with a bmi of 27 or greater who have at least one weight. This is not a list of all drugs or health problems that interact with this medicine lorcaserin tablets.
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