There are a number of weight loss drugs on the horizon. This is a very busy year for the FDA. The drugs under review for approval include Lorcaserin (Arena Pharmaceutical), Contrave (Orexigen Therapeutics), and Qnexa (VIVUS).
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena’s most advanced drug candidate, lorcaserin, is intended for weight management, including weight loss and maintenance of weight loss, and has completed a pivotal Phase 3 clinical trial program. Arena submitted a New Drug Application for lorcaserin to the FDA in December 2009. Arena Home : Arena Pharmaceuticals
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. In addition to Contrave, the Company's second product, Empatic(TM), has completed Phase 2 clinical development. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. Orexigen Therapeutics.
VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes, obstructive sleep apnea and sexual health. The company’s lead product in clinical development, Qnexa®, has recently completed phase 3 clinical trials for the treatment of obesity; VIVUS filed an NDA with the U.S. FDA in December 2009. Vivus - Welcome
Arena Pharmaceuticals Receives PDUFA Date for Lorcaserin NDA
Arena Home : Arena Pharmaceuticals
FDA Assigns October 22, 2010, PDUFA Date -
SAN DIEGO, Feb. 26, 2010 /PRNewswire via COMTEX News Network/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of October 22, 2010, for the review of the lorcaserin New Drug Application (NDA). The acceptance of the lorcaserin NDA filing confirms that the application is sufficiently complete to permit a substantive review, and the PDUFA date is the goal date for the FDA to complete its review of the NDA.
Lorcaserin is Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss, and is intended for obese patients or overweight patients with at least one weight-related co-morbid condition.
Jack Lief, Arena's President and Chief Executive Officer, stated, "With an October PDUFA date for the lorcaserin NDA, we are another step closer to our goal of improving the treatment of obesity. We believe that lorcaserin, if approved, will be well positioned as first-line therapy to help patients achieve sustainable weight loss in a well-tolerated manner."
The NDA is based on a data package from lorcaserin's development program that includes 18 clinical trials totaling 8,576 patients. The pivotal Phase 3 clinical trial program, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), evaluated nearly 7,200 patients treated for up to two years. In both trials, lorcaserin produced statistically significant weight loss with excellent safety and tolerability.
Phase 3 Program Overview
BLOOM and BLOSSOM comprise the pivotal Phase 3 program and are the basis of the lorcaserin NDA. These double-blind, randomized, placebo-controlled trials evaluated obese patients, Body Mass Index (BMI) 30 to 45, with or without co-morbid conditions and overweight patients, BMI 27 to 29.9, with at least one co-morbid condition, such as hypertension, cardiovascular diseases or glucose intolerance.
In addition to the pivotal program, Arena is evaluating lorcaserin in obese and overweight patients with type 2 diabetes in its BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial. Arena plans to file the results of BLOOM-DM as a supplement to the NDA.
About Lorcaserin
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Orexigen(R) Therapeutics Submits Contrave(R) New Drug Application to FDA for the Treatment of Obesity
Orexigen Therapeutics
SAN DIEGO, March 31, 2010 /PRNewswire via COMTEX/ --Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX) today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave(R) (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.
"The COR program was designed to address all the elements of the FDA guidance for weight loss and weight maintenance in patients with obesity. We believe that if approved, Contrave has the potential to serve the diverse needs of obese patients who currently have few treatment options," said Mike Narachi, President and CEO of Orexigen. "I want to extend my appreciation to the Orexigen team as well as the investigators and patients who participated in the COR program, which provided the high quality data supporting the submission."
Below are highlights from the COR program reported previously:
Contrave clearly met the FDA efficacy benchmark: 48% and 56% of patients on Contrave32 lost at least 5% of their body weight in COR-I and COR-II on an intent-to-treat basis, as compared to 16% and 18% of placebo patients who lost at least 5%, respectively (p<0.001).
Significant improvements were observed in cardiometabolic risk factors such as waist circumference, visceral fat, C-reactive protein, HDL cholesterol and triglycerides.
In the COR-Diabetes trial, patients with type 2 diabetes experienced significant weight loss and demonstrated meaningful reductions in HBA1c. Specifically, 45% of patients on Contrave32 lost at least 5% of their body weight on an intent-to-treat basis, compared to 19% of patients on placebo (p<0.001). Contrave patients also showed a 0.6% reduction in hemoglobin A1c (HbA1c) from baseline, compared to a 0.1% reduction in placebo (p<0.001).
Patients treated with Contrave demonstrated statistically significant improvement in quality of life, and in self reported exploratory measures of control of eating.
The safety profile of Contrave(R) was found to be consistent with the safety of the two approved active ingredients. The most common adverse reactions (greater than or equal to 5% and at least twice the incidence of placebo patients) were nausea, constipation, vomiting, dizziness and dry mouth. Serious events were reported infrequently and included events of cholecystitis (NB 0.2%, PBO <0.1%), seizure (NB <0.1%, PBO 0%), and major cardiovascular events (NB <0.1%, PBO <0.1%).
"Having achieved this important milestone, we can now focus for the remainder of 2010 on managing the review and approval process for Contrave with the FDA, preparing for the launch of Contrave, and partnership," said Mike Narachi.
About the COR Phase 3 Program
All four trials in the COR Phase 3 program (COR-I, COR-II, COR-BMOD and COR- Diabetes) were randomized, double-blind, placebo-controlled trials, including a four week titration period. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo. These endpoints were calculated based on intent-to-treat (ITT) last observation carried forward (LOCF) analyses of all randomized patients who had at least one post-baseline observation while on study drug. Secondary endpoints included multiple measures of cardiometabolic risk, quality of life, and control of eating, as well as HbA1c in the COR-Diabetes trial.
About Contrave
Contrave is an investigational combination therapy believed to address both physiological and behavioral drivers of obesity. The two components of this combination therapy act in a complementary manner in the central nervous system. The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behavior. In clinical trials Contrave was shown to help obese patients initiate and sustain significant weight loss, improve important markers of cardiometabolic risk and increase ability to control eating.
VIVUS Announces Date of FDA Advisory Committee Review of Qnexa(R) for the Treatment of Obesity
http://ir.vivus.com/releasedetail.cfm?ReleaseID=454859 (VIVUS, Inc. - VIVUS Announces Date of FDA Advisory Committee Review of Qnexa(R) for the Treatment of Obesity)
Endocrinologic and Metabolic Drugs Advisory Committee Meeting Tentatively Scheduled for July 15, 2010
MOUNTAIN VIEW, Calif., March 26, 2010 /PRNewswire via COMTEX News Network/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is tentatively scheduled to review the Company's New Drug Application (NDA) for Qnexa(R) for the treatment of obesity on July 15, 2010. VIVUS submitted its NDA on December 28, 2009 seeking approval to market Qnexa in the United States; on March 1, 2010, the FDA accepted the NDA filing for review. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010.
"Review by the Advisory Committee represents a critical milestone for Qnexa and for VIVUS. We believe Qnexa, if approved, could become a treatment option for obese patients," stated Leland Wilson, chief executive officer of VIVUS. "We look forward to discussing the efficacy and safety data of Qnexa with the members of the Endocrinologic and Metabolic Drugs Advisory Committee."
The FDA will publish the final meeting date in the Federal Register FDA Federal Registers (FR) .
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena’s most advanced drug candidate, lorcaserin, is intended for weight management, including weight loss and maintenance of weight loss, and has completed a pivotal Phase 3 clinical trial program. Arena submitted a New Drug Application for lorcaserin to the FDA in December 2009. Arena Home : Arena Pharmaceuticals
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. In addition to Contrave, the Company's second product, Empatic(TM), has completed Phase 2 clinical development. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. Orexigen Therapeutics.
VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes, obstructive sleep apnea and sexual health. The company’s lead product in clinical development, Qnexa®, has recently completed phase 3 clinical trials for the treatment of obesity; VIVUS filed an NDA with the U.S. FDA in December 2009. Vivus - Welcome
Arena Pharmaceuticals Receives PDUFA Date for Lorcaserin NDA
Arena Home : Arena Pharmaceuticals
FDA Assigns October 22, 2010, PDUFA Date -
SAN DIEGO, Feb. 26, 2010 /PRNewswire via COMTEX News Network/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of October 22, 2010, for the review of the lorcaserin New Drug Application (NDA). The acceptance of the lorcaserin NDA filing confirms that the application is sufficiently complete to permit a substantive review, and the PDUFA date is the goal date for the FDA to complete its review of the NDA.
Lorcaserin is Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss, and is intended for obese patients or overweight patients with at least one weight-related co-morbid condition.
Jack Lief, Arena's President and Chief Executive Officer, stated, "With an October PDUFA date for the lorcaserin NDA, we are another step closer to our goal of improving the treatment of obesity. We believe that lorcaserin, if approved, will be well positioned as first-line therapy to help patients achieve sustainable weight loss in a well-tolerated manner."
The NDA is based on a data package from lorcaserin's development program that includes 18 clinical trials totaling 8,576 patients. The pivotal Phase 3 clinical trial program, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), evaluated nearly 7,200 patients treated for up to two years. In both trials, lorcaserin produced statistically significant weight loss with excellent safety and tolerability.
Phase 3 Program Overview
BLOOM and BLOSSOM comprise the pivotal Phase 3 program and are the basis of the lorcaserin NDA. These double-blind, randomized, placebo-controlled trials evaluated obese patients, Body Mass Index (BMI) 30 to 45, with or without co-morbid conditions and overweight patients, BMI 27 to 29.9, with at least one co-morbid condition, such as hypertension, cardiovascular diseases or glucose intolerance.
In addition to the pivotal program, Arena is evaluating lorcaserin in obese and overweight patients with type 2 diabetes in its BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial. Arena plans to file the results of BLOOM-DM as a supplement to the NDA.
About Lorcaserin
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Orexigen(R) Therapeutics Submits Contrave(R) New Drug Application to FDA for the Treatment of Obesity
Orexigen Therapeutics
SAN DIEGO, March 31, 2010 /PRNewswire via COMTEX/ --Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX) today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave(R) (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.
"The COR program was designed to address all the elements of the FDA guidance for weight loss and weight maintenance in patients with obesity. We believe that if approved, Contrave has the potential to serve the diverse needs of obese patients who currently have few treatment options," said Mike Narachi, President and CEO of Orexigen. "I want to extend my appreciation to the Orexigen team as well as the investigators and patients who participated in the COR program, which provided the high quality data supporting the submission."
Below are highlights from the COR program reported previously:
Contrave clearly met the FDA efficacy benchmark: 48% and 56% of patients on Contrave32 lost at least 5% of their body weight in COR-I and COR-II on an intent-to-treat basis, as compared to 16% and 18% of placebo patients who lost at least 5%, respectively (p<0.001).
Significant improvements were observed in cardiometabolic risk factors such as waist circumference, visceral fat, C-reactive protein, HDL cholesterol and triglycerides.
In the COR-Diabetes trial, patients with type 2 diabetes experienced significant weight loss and demonstrated meaningful reductions in HBA1c. Specifically, 45% of patients on Contrave32 lost at least 5% of their body weight on an intent-to-treat basis, compared to 19% of patients on placebo (p<0.001). Contrave patients also showed a 0.6% reduction in hemoglobin A1c (HbA1c) from baseline, compared to a 0.1% reduction in placebo (p<0.001).
Patients treated with Contrave demonstrated statistically significant improvement in quality of life, and in self reported exploratory measures of control of eating.
The safety profile of Contrave(R) was found to be consistent with the safety of the two approved active ingredients. The most common adverse reactions (greater than or equal to 5% and at least twice the incidence of placebo patients) were nausea, constipation, vomiting, dizziness and dry mouth. Serious events were reported infrequently and included events of cholecystitis (NB 0.2%, PBO <0.1%), seizure (NB <0.1%, PBO 0%), and major cardiovascular events (NB <0.1%, PBO <0.1%).
"Having achieved this important milestone, we can now focus for the remainder of 2010 on managing the review and approval process for Contrave with the FDA, preparing for the launch of Contrave, and partnership," said Mike Narachi.
About the COR Phase 3 Program
All four trials in the COR Phase 3 program (COR-I, COR-II, COR-BMOD and COR- Diabetes) were randomized, double-blind, placebo-controlled trials, including a four week titration period. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo. These endpoints were calculated based on intent-to-treat (ITT) last observation carried forward (LOCF) analyses of all randomized patients who had at least one post-baseline observation while on study drug. Secondary endpoints included multiple measures of cardiometabolic risk, quality of life, and control of eating, as well as HbA1c in the COR-Diabetes trial.
About Contrave
Contrave is an investigational combination therapy believed to address both physiological and behavioral drivers of obesity. The two components of this combination therapy act in a complementary manner in the central nervous system. The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behavior. In clinical trials Contrave was shown to help obese patients initiate and sustain significant weight loss, improve important markers of cardiometabolic risk and increase ability to control eating.
VIVUS Announces Date of FDA Advisory Committee Review of Qnexa(R) for the Treatment of Obesity
http://ir.vivus.com/releasedetail.cfm?ReleaseID=454859 (VIVUS, Inc. - VIVUS Announces Date of FDA Advisory Committee Review of Qnexa(R) for the Treatment of Obesity)
Endocrinologic and Metabolic Drugs Advisory Committee Meeting Tentatively Scheduled for July 15, 2010
MOUNTAIN VIEW, Calif., March 26, 2010 /PRNewswire via COMTEX News Network/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is tentatively scheduled to review the Company's New Drug Application (NDA) for Qnexa(R) for the treatment of obesity on July 15, 2010. VIVUS submitted its NDA on December 28, 2009 seeking approval to market Qnexa in the United States; on March 1, 2010, the FDA accepted the NDA filing for review. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010.
"Review by the Advisory Committee represents a critical milestone for Qnexa and for VIVUS. We believe Qnexa, if approved, could become a treatment option for obese patients," stated Leland Wilson, chief executive officer of VIVUS. "We look forward to discussing the efficacy and safety data of Qnexa with the members of the Endocrinologic and Metabolic Drugs Advisory Committee."
The FDA will publish the final meeting date in the Federal Register FDA Federal Registers (FR) .
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