WOODCLIFF LAKE, N.J. and SAN DIEGO, Oct. 28, 2014 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ:
) today announced top-line results of a pilot study to assess the safety of lorcaserin HCl, a serotonin 2C receptor agonist, when coadministered with phentermine HCl. The results of the investigational study demonstrate that the short-term combination of lorcaserin plus phentermine does not appear to be associated with an exacerbation in the proportion of pre-specified adverse events compared to therapy with lorcaserin alone.
The coadministration of lorcaserin and phentermine for weight management is investigational. The efficacy and safety of coadministration of lorcaserin and other weight loss products such as phentermine have not been established.
The randomized, double-blind pilot study of 12-weeks duration in overweight and obese adults evaluated whether short-term treatment with lorcaserin 10 mg twice daily (BID) plus two doses of immediate-release phentermine, 15 mg once daily (QD) or 15 mg BID, is associated with exacerbation of potential serotonergic adverse events compared to lorcaserin alone. In the trial, 238 subjects were randomized to one of the three treatment arms in a 1:1:1 ratio and received standardized weight-loss counseling during the trial.
"The results of this investigational study provide us with additional safety data that enhance the body of knowledge we have for lorcaserin," said Gary Palmer, MD, Eisai's Chief Medical Officer. "We look forward to sharing the detailed results with the medical community at The Obesity Society's Annual Scientific Meeting during ObesityWeek taking place November 2-7 in Boston."
The primary endpoint of the trial assessed the proportion of subjects reporting at least one of nine common potential serotonergic adverse events (headache, dizziness, nausea, fatigue, dry mouth, diarrhea, vomiting, insomnia, and/or anxiety) from baseline to the end of treatment. As a safety study, the arms were compared based on descriptive statistics.
The most common adverse events in the study overall were dry mouth, headache, constipation, fatigue and dizziness.
About BELVIQ® (lorcaserin HCl) CIV
Lorcaserin is marketed in the United States under the brand name BELVIQ. The prescribing information for BELVIQ contains a limitation of use for coadministration of lorcaserin and phentermine. BELVIQ is a serotonin 2C receptor agonist approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes the risk of heart problems or stroke, or death due to heart problems or stroke.
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.
IMPORTANT SAFETY INFORMATION
Contraindication
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 (e.g., cabergoline). In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of patients taking placebo developed valvular regurgitation: none of these patients was 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 (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., 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
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%).
Nursing Mothers
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 drug dependence.
For more information about BELVIQ,
for the full US FDA-approved Product Information or visit .
Eisai is responsible for the marketing and distribution of BELVIQ in most territories worldwide under its agreement with Arena. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena's internally discovered drug, BELVIQ® (lorcaserin HCl), is approved in the United States, and Arena is focused on discovering, developing and commercializing additional drugs to address unmet medical needs. Arena's US operations are located in San Diego, California, and its operations outside of the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arena's website at .
Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc.
About Eisai Inc.
At Eisai Inc., human health care is our goal. Eisai gives its first thoughts to patients and their families, and helping to increase the benefits health care provides. As the US pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., Eisai has a passionate commitment to patient care that is the driving force behind Eisai's efforts to help address unmet medical needs. Eisai is 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 .
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
vascular, inflammatory and im and antibody-based programs.
Forward-Looking Statements
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 advancement, therapeutic indication, use, safety, efficacy, mechanism of action, and potential of BELVIQ or lorcaserin, including with respect to coadministrat significance of the top-line results of the pilot study assessing the safety of lorcaserin when coadministered with phentermine, including providing additional safety data that enhances the body of know future presentation
rights, obligations and activities under the marketing and supply agreement among Arena and E embracing the challenge seeking to bring innovative m and Arena's focus, plans, goals, strategy, expectations, research and development programs, and ability to discover and develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: top-line results are not comprehensive and are based on a preliminary analysis of then available data, and findings and conclusions related to the trial are subject to change following a more comprehensiv risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and the availability and use of BELVIQ; cash and revenues generated from BELVIQ, including the i Arena's revenues will be based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena's guidance or previou the timing and outcome of regulatory review is uncertain, and BELVIQ may not be approved for marketing when expected or ever in combination with another drug, for another indication or using a different formulation or in any other territor regulatory decisions in one territory may impact other regulatory decisions and Arena' government and commercial reimbursement a risks related to relying on collab the timing and receipt of payments and fees, if any, the entry into or modification or termination of collab unexpected or
nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements befo data and other information related to any of Arena's research and development may not meet regulatory requirements or otherwise be sufficient for (or Arena or a collaborator may not pursue) further research and development, regulatory review or approval or Arena's ability to obtai the timing, success and cost of Arena's rese results of clinical trials and other studies are subject to different interpretations and may not be predicti clinical trials and other studies may not proceed at the time or in the manne h and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Contacts: Eisai Inc.
Investor Inquiries: 
Media Inquiries:
Alex Scott 
Laurie Landau
201.746.2177
201.746.2510
Contact: Arena Pharmaceuticals, Inc. 
Craig M. Audet, Ph.D., Senior Vice President,
David Schull, President
Operations & Head of Global Regulatory Affairs
Russo Partners
858.453.7200, ext. 1612
858.717.2310
Arena Pharmaceuticals, Inc.; Eisai Inc.
RELATED LINKS
Journalists and Bloggers
The news you need, when you need it.
to access all of the free services designated to make your job easier.
In need of subject matter experts for your story?
and find the sources you need.
LEARN MORE
Looking to send a news release with PR Newswire?
Take advantage of the world's leading distribution platform.
Have an account?
Searching for your content...
Share this articleArena怎么把报告导入word_百度知道
色情、暴力
我们会通过消息、邮箱等方式尽快将举报结果通知您。
Arena怎么把报告导入word
转Excel和PDF都可以，word就不行，怎么回事啊？？
我有更好的答案
为您推荐：
其他类似问题
您可能关注的内容
arena的相关知识
换一换
回答问题，赢新手礼包君，已阅读到文档的结尾了呢~~
扫扫二维码，随身浏览文档
手机或平板扫扫即可继续访问
Arena讲解(一)
举报该文档为侵权文档。
举报该文档含有违规或不良信息。
反馈该文档无法正常浏览。
举报该文档为重复文档。
推荐理由：
将文档分享至：
分享完整地址
文档地址：
粘贴到BBS或博客
flash地址：
支持嵌入FLASH地址的网站使用
html代码：
&embed src='/DocinViewer-4.swf' width='100%' height='600' type=application/x-shockwave-flash ALLOWFULLSCREEN='true' ALLOWSCRIPTACCESS='always'&&/embed&
450px*300px480px*400px650px*490px
支持嵌入HTML代码的网站使用
您的内容已经提交成功
您所提交的内容需要审核后才能发布，请您等待！
3秒自动关闭窗口}