Navigation Links
Arena Pharmaceuticals' Lorcaserin for Obesity Passes Major Safety Milestone
Date:3/17/2008

- Month-12 Independent Echocardiographic Data Safety Monitoring Board Review Strengthens Lorcaserin's Emerging Cardiovascular Safety Profile -

SAN DIEGO, March 17 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today that following a planned review by an independent Echocardiographic Data Safety Monitoring Board (EDSMB) it is continuing BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), a pivotal trial evaluating the efficacy and safety of lorcaserin hydrochloride for the treatment of obesity. The EDSMB's review of unblinded echocardiographic data performed after patients completed 12 months of dosing in the trial confirmed that differences, if any, in the rates of Food and Drug Administration (FDA)-defined valvulopathy in patients treated with lorcaserin and in the control group did not meet the EDSMB's predetermined stopping criteria. Based on the EDSMB's review of the rate of FDA-defined valvulopathy, Arena has been able to confirm that the statistical power calculations used in the design of the Phase 3 trial program to monitor patients for increased risk of developing valvulopathy are justified. The findings from the month-12 review build on the EDSMB's September 2007 review that evaluated echocardiograms after 6 months of dosing.

"This critical milestone assessing month-12 echocardiographic data strongly supports lorcaserin's cardiovascular safety profile. We believe that this exposure duration, even under a conservative interpretation of the literature, would have been sufficient to observe a fenfluramine like effect on heart valves if present. BLOOM's primary echo endpoint is based on the month-12 data," said Jack Lief, Arena's President and Chief Exe
'/>"/>

SOURCE Arena Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

2

GOOD

Page: 1 2 3 4 5 6

Related medicine news :

1. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
2. Arena Pharmaceuticals Announces Public Offering of Common Stock
3. Arena Pharmaceuticals to Present at the BIOCOM Investor Conference
4. Arena Pharmaceuticals Announces Pricing of Public Offering of Common Stock
5. Arena Pharmaceuticals to Present at the Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference
6. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
7. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
8. Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
9. Vista Partners Updates Coverage on Tapestry Pharmaceuticals
10. Transcept Pharmaceuticals, Inc. to Present at UBS 2007 Global Life Sciences Conference
11. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Tapestry Pharmaceuticals, Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2013)... York (PRWEB) May 25, 2013 Pradaxa ... suffered serious, life-threatening episodes of internal bleeding while using the ... in U.S. District Court, Southern District of Illinois, Bernstein Liebhard ... website, 818 Pradaxa side effect claims had been ... That’s up from 705 claims reported by the Court on ...
(Date:5/25/2013)... York, NY (PRWEB) May 25, 2013 ... dedicated to brain cancer research and advocacy, comments on ... Extraterrestrial Physics, that shows incorporating cold atmospheric plasma into ... cells. , According to a Science Daily ... Extraterrestrial Physics (MPE), biologists and physicians demonstrated the “synergistic ...
(Date:5/25/2013)... 25, 2013 Dr. Farooq Ashraf, founder ... in Dubai, has announced his practice’s adoption of The ... only FDA-cleared femtosecond laser proven with more than 10 ... precision of LASIK. , “We are happy to announce ... Laser at our Dubai LASIK practice,” Ashraf said Thursday. ...
(Date:5/25/2013)... 2013 The Slim Weight Patch has been ... This is due to the highly sought after ingredients that ... patch offers an extra 2 months supply & premium membership ... get the body you desire faster than ever. , ... , With Slim weight patch consumers can observe instant results ...
(Date:5/25/2013)... Texas (PRWEB) May 25, 2013 ... stressful than finals week. Increasingly, they are turning ... stay awake and study. For more on this, ... a drug treatment facility, warns that students who ... finals” are at risk for developing a physical ...
Breaking Medicine News(10 mins):Health News:Pradaxa Lawsuits Mount, as Filings in Federal Pradaxa Side Effect Litigation Exceed 800, Bernstein Liebhard LLP Reports 2Health News:Pradaxa Lawsuits Mount, as Filings in Federal Pradaxa Side Effect Litigation Exceed 800, Bernstein Liebhard LLP Reports 3Health News:Voices Against Brain Cancer Comments on Study that Shows Cold Plasma’s Success Against Brain Cancer Cells 2Health News:Atlanta Vision Clinic Acquires the Latest in Blade-Free Lasik Technology Bringing Dubai Patients the Intralase Method 2Health News:Slim Weight Patch Advanced Weight Loss System Offers Extra Two Month Supply and Membership for Maximum Weight Loss 2Health News:Addiction and Drug Abuse: Study Drug Adderall Abuse Spikes During Finals 2
... (NYSE: SCI ) announced it expects to issue a press release ... 2009, after the market closes. A conference call will be hosted ... conference call are as follows: , , ... Conference Call, ...
... ... , ... 2, 2009 -- Life Care Centers of America recently named Michael Lops as ... Life Care, succeeds Sharon Coleman in the position. His appointment is based on “his extensive ...
... visit questionnaire led to screening in high-risk study patients ... questionnaire can identify patients at high risk for lung ... in 2001 with 1,000 people in Colorado who were ... patients were asked to complete a five-minute questionnaire that ...
... ... become a certifying body upon the release of the Office of the National Coordinator for ... Group has been approached recently by numerous EHR software and services companies that need to ... Fort Worth, ...
... Nov. 2 What do sipping cocoa, snuggling under blankets ... more common during the cold winter months. , According ... 1,200 Americans die annually from a heart attack or similar ... is often the trigger. To help create awareness, work to ...
... 2 /PRNewswire-Asia-FirstCall/ -- China Medical Technologies,Inc. (the "Company") (Nasdaq: ... develops, manufactures and markets advanced in-vitro diagnostic,products, today announced ... second fiscal quarter ended September 30, 2009 ("2Q FY2009") ... The Company,s 2009 fiscal year,ends on March 31, 2010. ...
Cached Medicine News:Health News:Service Corporation International Announces Schedule for Its Third Quarter 2009 Earnings Release and Conference Call 2Health News:Lops named Life Care's New Chief Compliance Officer 2Health News:Drummond Group Plans to Certify Electronic Health Records 2Health News:Drummond Group Plans to Certify Electronic Health Records 3Health News:MTD Joins Forces with the AHA to Promote Heart Health 2Health News:China Medical Technologies to Announce Unaudited Financial Results for the Second Fiscal Quarter Ended September 30, 2009 on November 19, 2009 2
(Date:5/24/2013)... -- The potential of the pulmonary route ... agents has been receiving undeniable attention with the recent ... The crucial formulation considerations for orally inhaled products together ... role in the efficiency of pulmonary delivery, and great ... formulation techniques and devices in recent years. ...
(Date:5/23/2013)... PARÍS, 24 de mayo de 2013  Volcano ... desarrollador y fabricante de herramientas de precisión para ... tratamiento de la enfermedad vascular periférica y coronaria, ... ( Ad enosine V asodilator I ... durante la sesión de ensayo clínico hot line ...
(Date:5/23/2013)... Nephros, Inc. (OTC Bulletin Board: ... develops and sells high performance liquid purification ultrafilters, announced ... addition, the concurrent temporary reduction in exercise price for ... 2013. Nephros estimates that it will receive ... A portion of the proceeds will be used for ...
Breaking Medicine Technology:Inhalaltion Drug Delivery: 11-12 September - Berlin, Germany 2Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 2Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 3Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 4Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 5Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 6Nephros Announces Completion of Rights Offering 2Nephros Announces Completion of Rights Offering 3Nephros Announces Completion of Rights Offering 4
... 18, 2012 UCB, Inc., a leading biopharmaceutical company ... severe central nervous system and immunological disorders, is marking ... reinforcing its commitment to improving the lives of patients ... this year,s DDW meeting. "DDW is ...
... The new arthroscopy simulator ArthroS trains orthopedic surgeons for ... The Swiss company VirtaMed AG is launching ArthroS™, a ... get the chance to practice different operations numerous times ... as pilots improve their skills on flight simulators. ArthroS™ ...
Cached Medicine Technology:UCB Proudly Reinforces Long-Standing Commitment to Crohn's Disease Community at Digestive Disease Week 2012 2UCB Proudly Reinforces Long-Standing Commitment to Crohn's Disease Community at Digestive Disease Week 2012 3UCB Proudly Reinforces Long-Standing Commitment to Crohn's Disease Community at Digestive Disease Week 2012 4Swiss Engineering for Surgical Perfection 2Swiss Engineering for Surgical Perfection 3
... a new standard in QPCR with the ... system offers superior performance, more flexibility, and ... system - with Windows 98SE and Pentium ... Premier Sound Speakers, Surge Protector (US only), ...
... The LightCycler System is the ... The LightCycler System enables you to ... 30 min, and simultaneously quantify and ... during amplification. The unique Melting Curve ...
... ABI PRISM 7900HT Sequence Detection System ... that detects and quantitates nucleic acid ... 384-well plate capability make the 7900HT ... high-throughput requirements of todays drug discovery ...
Sealing Mat for 96-well, 2.0ml, Deep Well, Square Available Sterile...
Medicine Products: