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:
Breaking Medicine Technology:Maxygen, Inc. Announces Extension of Dutch Auction Tender Offer 2Circassia Raises GBP15 Million ($25 Million) in Oversubscribed Investment Round 2Boston Scientific Announces Pricing of $2 Billion of Senior Notes 2Boston Scientific Announces Pricing of $2 Billion of Senior Notes 3FDNY Makes Largest First Responder Purchase of Masimo Rad 57 Pulse CO Oximeters to Improve Survival of Firefighters and Victims of Carbon Monoxide Poi 56362 1FDNY Makes Largest First Responder Purchase of Masimo Rad 57 Pulse CO Oximeters to Improve Survival of Firefighters and Victims of Carbon Monoxide Poi 56362 2FDNY Makes Largest First Responder Purchase of Masimo Rad 57 Pulse CO Oximeters to Improve Survival of Firefighters and Victims of Carbon Monoxide Poi 56362 3FDNY Makes Largest First Responder Purchase of Masimo Rad 57 Pulse CO Oximeters to Improve Survival of Firefighters and Victims of Carbon Monoxide Poi 56362 4Multiple Abstracts Related to KRYSTEXXA 28TM 29 Development and Treatment Failure Gout to be Presented at the 2009 ACR ARHP Annual Scientific Meeting 13887 1Multiple Abstracts Related to KRYSTEXXA 28TM 29 Development and Treatment Failure Gout to be Presented at the 2009 ACR ARHP Annual Scientific Meeting 13887 2Multiple Abstracts Related to KRYSTEXXA 28TM 29 Development and Treatment Failure Gout to be Presented at the 2009 ACR ARHP Annual Scientific Meeting 13887 3Multiple Abstracts Related to KRYSTEXXA 28TM 29 Development and Treatment Failure Gout to be Presented at the 2009 ACR ARHP Annual Scientific Meeting 13887 4Working Moms Vision Not Near Perfect 56357 1Working Moms Vision Not Near Perfect 56357 2Working Moms Vision Not Near Perfect 56357 3