BETHESDA, MD 28 June 2012—FDA on Wednesday approved the marketing of lorcaserin hydrochloride, or Belviq, for chronic weight management in obese and certain overweight adults who are also reducing their caloric intake and increasing their physical activity.
By activating serotonin type 2C receptors in the brain, lorcaserin may help people eat less food and feel full after eating smaller amounts, the agency said.
The product's labeling (PDF) describes two populations of patients suitable for lorcaserin therapy:
- Adults with an initial body mass index of 30 kg/m2 or more who are not pregnant, and
- Adults with an initial body mass index of 27 kg/m2 or more who also have hypertension, dyslipidemia, type 2 diabetes mellitus, or another weight-related condition and are not pregnant.
For both populations of patients, the labeling recommends a lorcaserin hydrochloride dosage of one 10-mg tablet twice daily.
The labeling states that therapy with the drug should stop if, by week 12, patients have not lost at least 5% of their initial body weight. In the two studies of obese or overweight patients without type 2 diabetes, those who did not lose at least 5% of their body weight by week 12 were unlikely to achieve that milestone by week 52.
Because lorcaserin activates serotonin receptors in the brain, the labeling advises extreme caution in using that drug in combination with any other substance that may affect the serotonergic neurotransmitter systems.
FDA said the drug's most common adverse effects in patients without diabetes were headache, dizziness, fatigue, nausea, dry mouth, and constipation.
In patients with diabetes, FDA said, the drug's most common adverse effects were hypoglycemia, headache, back pain, cough, and fatigue.
The product will not become available until the Drug Enforcement Administration decides in which controlled-substance schedule the serotonin type 2C-receptor agonist belongs, Eisai Inc. and Arena Pharmaceuticals Inc. said.
According to Belviq's labeling, lorcaserin 40 and 60 mg produced hallucinations and sedation similar to zolpidem 15 and 30 mg and ketamine 100 mg in a study of recreational drug abusers.
Eisai will market Belviq, which is manufactured by Arena.