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Lorcaserin, a serotonin receptor agonist approved as a weight loss agent in 2012, has been scheduled as a schedule IV drug and is expected to be available within weeks, according to the manufacturer, Arena Pharmaceuticals.
The Drug Enforcement Administration (DEA) has placed lorcaserin (Belviq) in the schedule IV category of the Controlled Substances Act, which is for drugs with "a low potential for abuse and low risk of dependence." Other schedule IV drugs are alprazolam (Xanax), diazepam (Valium), and zolpidem (Ambien). Lorcaserin will be available 30 days after the final rule on the scheduling is published in the May 8th Federal Register, according to a May 7 statement issued by Arena.
The final rule in the Federal Register says that, on the basis of a review of the available data, the DEA determined that lorcaserin has a low potential for abuse relative to schedule III drugs, such as ketamine, and that the overall abuse potential of lorcaserin is comparable to schedule IV drugs, such a zolpidem. "Abuse of lorcaserin may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. This finding is based on the ability of lorcaserin to produce positive subjective effects at supratherapeutic doses," according to the final rule.
After two FDA advisory panel meetings, the FDA approved lorcaserin in June 2012 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of at least 30 kg/m2 (obese), or at least 27 kg/m2 (overweight) with at least one weight-related comorbid condition. The drug could not be marketed until the DEA finalized its decision regarding scheduling.
Because of concerns regarding the potential for valvulopathy associated with treatment, the company’s postmarketing commitments include conducting six studies, including a long-term cardiovascular outcomes trial. The prescribing information includes a recommendation to consider discontinuing treatment if patients develop signs to symptoms indicative of valvular heart disease and to evaluate patients for valvulopathy. Lorcaserin activates the serotonin 2C receptor, but at the approved dose of 10 mg twice a day, "does not appear to activate the serotonin 2B receptor," the FDA said in the June 27, 2012, approval announcement.
Weight-loss drugs fenfluramine and dexfenfluramine were taken off the market in 1997 after they were associated with valvular damage that was thought to be related to activation of the serotonin 2B receptor on cardiac tissue, according to the FDA.
Arena will be marketing lorcaserin as Belviq.
Lorcaserin, a serotonin receptor agonist approved as a weight loss agent in 2012, has been scheduled as a schedule IV drug and is expected to be available within weeks, according to the manufacturer, Arena Pharmaceuticals.
The Drug Enforcement Administration (DEA) has placed lorcaserin (Belviq) in the schedule IV category of the Controlled Substances Act, which is for drugs with "a low potential for abuse and low risk of dependence." Other schedule IV drugs are alprazolam (Xanax), diazepam (Valium), and zolpidem (Ambien). Lorcaserin will be available 30 days after the final rule on the scheduling is published in the May 8th Federal Register, according to a May 7 statement issued by Arena.
The final rule in the Federal Register says that, on the basis of a review of the available data, the DEA determined that lorcaserin has a low potential for abuse relative to schedule III drugs, such as ketamine, and that the overall abuse potential of lorcaserin is comparable to schedule IV drugs, such a zolpidem. "Abuse of lorcaserin may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. This finding is based on the ability of lorcaserin to produce positive subjective effects at supratherapeutic doses," according to the final rule.
After two FDA advisory panel meetings, the FDA approved lorcaserin in June 2012 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of at least 30 kg/m2 (obese), or at least 27 kg/m2 (overweight) with at least one weight-related comorbid condition. The drug could not be marketed until the DEA finalized its decision regarding scheduling.
Because of concerns regarding the potential for valvulopathy associated with treatment, the company’s postmarketing commitments include conducting six studies, including a long-term cardiovascular outcomes trial. The prescribing information includes a recommendation to consider discontinuing treatment if patients develop signs to symptoms indicative of valvular heart disease and to evaluate patients for valvulopathy. Lorcaserin activates the serotonin 2C receptor, but at the approved dose of 10 mg twice a day, "does not appear to activate the serotonin 2B receptor," the FDA said in the June 27, 2012, approval announcement.
Weight-loss drugs fenfluramine and dexfenfluramine were taken off the market in 1997 after they were associated with valvular damage that was thought to be related to activation of the serotonin 2B receptor on cardiac tissue, according to the FDA.
Arena will be marketing lorcaserin as Belviq.
Lorcaserin, a serotonin receptor agonist approved as a weight loss agent in 2012, has been scheduled as a schedule IV drug and is expected to be available within weeks, according to the manufacturer, Arena Pharmaceuticals.
The Drug Enforcement Administration (DEA) has placed lorcaserin (Belviq) in the schedule IV category of the Controlled Substances Act, which is for drugs with "a low potential for abuse and low risk of dependence." Other schedule IV drugs are alprazolam (Xanax), diazepam (Valium), and zolpidem (Ambien). Lorcaserin will be available 30 days after the final rule on the scheduling is published in the May 8th Federal Register, according to a May 7 statement issued by Arena.
The final rule in the Federal Register says that, on the basis of a review of the available data, the DEA determined that lorcaserin has a low potential for abuse relative to schedule III drugs, such as ketamine, and that the overall abuse potential of lorcaserin is comparable to schedule IV drugs, such a zolpidem. "Abuse of lorcaserin may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. This finding is based on the ability of lorcaserin to produce positive subjective effects at supratherapeutic doses," according to the final rule.
After two FDA advisory panel meetings, the FDA approved lorcaserin in June 2012 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of at least 30 kg/m2 (obese), or at least 27 kg/m2 (overweight) with at least one weight-related comorbid condition. The drug could not be marketed until the DEA finalized its decision regarding scheduling.
Because of concerns regarding the potential for valvulopathy associated with treatment, the company’s postmarketing commitments include conducting six studies, including a long-term cardiovascular outcomes trial. The prescribing information includes a recommendation to consider discontinuing treatment if patients develop signs to symptoms indicative of valvular heart disease and to evaluate patients for valvulopathy. Lorcaserin activates the serotonin 2C receptor, but at the approved dose of 10 mg twice a day, "does not appear to activate the serotonin 2B receptor," the FDA said in the June 27, 2012, approval announcement.
Weight-loss drugs fenfluramine and dexfenfluramine were taken off the market in 1997 after they were associated with valvular damage that was thought to be related to activation of the serotonin 2B receptor on cardiac tissue, according to the FDA.
Arena will be marketing lorcaserin as Belviq.