Publication in Federal Register Tomorrow Moves BELVIQ® (lorcaserin HCl) Closer To Launch PR Newswire WOODCLIFF LAKE, N.J., May 7, 2013 WOODCLIFF LAKE, N.J., May 7, 2013 /PRNewswire/ --Eisai Inc. announced today that the U.S. Drug Enforcement Administration (DEA) has placed BELVIQ (pronounced BEL-VEEK) into Schedule IV of the Controlled Substances Act. This information is expected to be published in the Federal Register on May 8, with an effective date of June 7, 2013. Eisai will issue a public statement when BELVIQ is available in the U.S. BELVIQ was approved by the FDA on June 27, 2012 for chronic weight management in adults who are overweight with a comorbidity or obese. About BELVIQ (lorcaserin HCl) Tablets BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of BELVIQ is not known. BELVIQ is a federally controlled substance (CIV) because it may be abused or lead to drug dependence. Indications BELVIQ is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a: oBody mass index (BMI) of 30 kg/m^2 or greater (obese), or oBMI of 27 kg/m^2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. Limitations of Use: oThe safety and effectiveness of BELVIQ in combination with prescription, over-the-counter, and herbal weight loss products is not known. oIt is not known if BELVIQ changes the risk of heart problems or stroke, or death due to heart problems or stroke. Important Safety Information oPregnancy: Do not take BELVIQ if you are pregnant or planning to become pregnant. BELVIQ may harm your unborn baby, as weight loss offers no potential benefit to a pregnant woman. oSerotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions: Before using BELVIQ, tell your doctor about all the medicines you take, especially medicines that treat depression, migraines, mental problems, or the common cold. These medicines may cause serious or life-threatening side effects if taken with BELVIQ. Call your doctor right away if you experience agitation, hallucinations, confusion, or other changes in mental status; coordination problems; uncontrolled muscle spasms; muscle twitching; restlessness; racing or fast heartbeat; high or low blood pressure; sweating; fever; nausea; vomiting; diarrhea; or stiff muscles. oValvular heart disease: Some people taking medicines like BELVIQ have had heart valve problems. Call your doctor right away if you experience trouble breathing; swelling of the arms, legs, ankles, or feet; dizziness, fatigue, or weakness that will not go away; or fast or irregular heartbeat. Before taking BELVIQ, tell your doctor if you have or have had heart problems. oChanges in attention or memory: BELVIQ may slow your thinking. You should not drive a car or operate heavy equipment until you know how BELVIQ affects you. oMental problems: Taking too much BELVIQ may cause hallucinations, feeling high or in a very good mood, or feelings of standing outside of your body. oDepression or thoughts of suicide: Call your doctor right away if you notice any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings, or if you have depression or thoughts of suicide. oLow blood sugar: Weight loss can cause low blood sugar in people taking medicines for type 2 diabetes, such as insulin or sulfonylureas. Blood sugar levels should be checked before and while taking BELVIQ. Changes to diabetes medication may be needed if low blood sugar develops. oPainful erections: If you have an erection lasting more than 4 hours while on BELVIQ, stop using BELVIQ and call your doctor or go to the nearest emergency room right away. oSlow heart beat: BELVIQ may cause your heart to beat slower. oDecreases in blood cell count: BELVIQ may cause your red and white blood cell count to decrease. oIncrease in prolactin: BELVIQ may increase the amount of a hormone called prolactin. Tell your doctor if your breasts begin to make milk or a milky fluid or if you are a male and your breasts begin to increase in size. oMost common side effects in patients without diabetes: Headache, dizziness, fatigue, nausea, dry mouth, and constipation. oMost common side effects in patients with diabetes: Low blood sugar, headache, back pain, cough, and fatigue. oNursing: BELVIQ should not be taken while breastfeeding. oDrug Interactions: Before taking BELVIQ, tell your doctor if you take medicines for depression, migraines or other medical conditions such as: triptans, medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or antipsychotics; cabergoline; linezolid (an antibiotic), tramadol, dextromethorphan (an over-the-counter (OTC) common cold/cough medicine), OTC supplements such as tryptophan or St. John's Wort, or erectile dysfunction medicines. For more information about BELVIQ, click here for the full Product Information or visit www.BELVIQ.com. Eisai Inc. At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US. Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs. BELVIQ^® is a registered trademark of Arena Pharmaceuticals GmbH. Media Inquiries Investor Inquiries Marcia Diljak Alex Scott Eisai Inc. Eisai Inc. (201) 746-2236 (201) 746-2177 SOURCE Eisai Inc. Website: http://www.eisai.com
Publication in Federal Register Tomorrow Moves BELVIQ® (lorcaserin HCl) Closer To Launch
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