Eisai and Arena Pharmaceuticals Announce Presentation of BELVIQ® (lorcaserin HCl) Data at 2016 Annual Obesity Week Meeting
Presentations of note include:
Effects of Lorcaserin on Lipid Parameters in Patients With Overweight or Obesity and Dyslipidemia
- Oral Presentation Number: T-OR-2070
- Session: Energy Balance: Causes and Consequences
- Presentation: 11/3/16;
3:45 pm- 5:15 pm
Ernest N. Morial Convention Center; Room 206-207
A post-hoc analysis that evaluated triglycerides (TG) and non-high-density lipoprotein cholesterol (non-HDL-C) after treatment with lorcaserin in a subset of patients without T2DM and with dyslipidemia at baseline (defined as: Fasting TG ≥200 mg/dL and/or non-HDL-C ≥160 mg/dL)
Health-Related Quality of Life in Randomized Controlled Trials of lorcaserin for Obesity Management: What Mediates Improvement?
- Poster Number: T-P3478
- Session: Pharmacological and Surgical Treatment of Obesity and Others
- Presentation: 11/4/16;
12:00 pm- 1:30 pm
Ernest N. Morial Convention Center; Exhibit Hall
A pooled analysis from three lorcaserin Phase 3 trials (BLOOM, BLOSSOM and BLOOM DM) to determine whether lorcaserin is associated with greater improvements in health-related quality of life and whether these improvements are solely attributable to weight loss.
This release discusses an investigational use for an
INDICATION FOR BELVIQ® (lorcaserin HCl) CIV
BELVIQ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obese), or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes).
Limitations of Use
- The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss, including prescription drugs (eg, phentermine), over-the-counter drugs, and herbal preparations, have not been established.
- The effect of BELVIQ on cardiovascular morbidity and mortality has not been established.
IMPORTANT SAFETY INFORMATION
- BELVIQ should not be taken during pregnancy or by women who are planning to become pregnant.
Warnings and Precautions
- BELVIQ is a serotonergic drug. The development of potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported during use of serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors, and selective serotonin reuptake inhibitors, tricyclic antidepressants, bupropion, triptans, dietary supplements such as St. John's Wort and tryptophan, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors), dextromethorphan, lithium, tramadol, antipsychotics or other dopamine antagonists, particularly when used in combination. Patients should be monitored for the emergence of serotonin syndrome symptoms or NMS-like reactions, including agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea, and muscle rigidity. Treatment with BELVIQ and any concomitant serotonergic or antidopaminergic agents should be discontinued immediately if the above events occur, and supportive symptomatic treatment should be initiated.
- Patients should not take BELVIQ in combination with drugs that have been associated with valvular heart disease (eg, cabergoline). In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of patients taking placebo developed valvular regurgitation: none of these patients were symptomatic. BELVIQ should be used with caution in patients with congestive heart failure (CHF). Patients who develop signs and symptoms of valvular heart disease, including dyspnea, dependent edema, CHF, or a new cardiac murmur, should be evaluated and discontinuation of BELVIQ should be considered.
- Impairment in attention, memory, somnolence, confusion, and fatigue, have been reported in patients taking BELVIQ. Patients should not drive a car or operate heavy machinery until they know how BELVIQ affects them.
- The recommended dose of 10 mg twice daily should not be exceeded, as higher doses may cause euphoria, hallucination, and dissociation. Monitor patients for the development or worsening of depression, suicidal thoughts or behaviors, and/or any changes in mood. Discontinue BELVIQ in patients who develop suicidal thoughts or behaviors.
- Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus who are being treated with antidiabetic medications, so measurement of blood sugar levels before and during treatment with BELVIQ is recommended. Decreases in doses of antidiabetic medications or changes in medication regimen should be considered.
- Men who experience priapism should immediately discontinue BELVIQ and seek emergency medical attention. BELVIQ should be used with caution with erectile dysfunction medications. BELVIQ should be used with caution in men who have conditions that might predispose them to priapism (eg, sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, or Peyronie's disease).
- Because BELVIQ may cause a slow heartbeat, it should be used with caution in patients with a history of bradycardia or heart block greater than first degree.
- Consider monitoring for CBC changes, prolactin excess, and pulmonary hypertension.
Most Common Adverse Reactions ( > 5% and more common than placebo)
- In patients without diabetes: headache (17%), dizziness (9%), fatigue (7%), nausea (8%), dry mouth (5%), and constipation (6%).
- In patients with diabetes: hypoglycemia (29%), headache (15%), back pain (12%), cough (8%), and fatigue (7%).
- BELVIQ should not be taken by women who are nursing.
BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to dependence.
For more information about BELVIQ, see full Prescribing Information.
We are a biopharmaceutical company focused on developing novel, small molecule drugs across a range of therapeutic areas. We have three primary proprietary investigational clinical programs: etrasimod (APD334) in Phase 2 evaluation for ulcerative colitis, APD371 entering Phase 2 evaluation for the treatment of pain associated with Crohn's disease, and ralinepag (APD811) in Phase 2 evaluation for pulmonary arterial hypertension (PAH). Additionally, we have collaborations with the following pharmaceutical companies:
Our US operations are located in
BELVIQ® is a registered trademarks of
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the therapeutic potential of BELVIQ; the need to address obesity;
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