Navigation Links
FDA Approves SOMA(R) (carisoprodol) 250 mg
Date:9/17/2007

ick, President & Chief Executive Officer of MedPointe Pharmaceuticals. "While SOMA has a long history in the treatment of discomfort associated with acute, painful musculoskeletal conditions with nearly 50 years on the market, we are pleased to provide a new recommended dose that provides a proven clinical benefit to help relieve the burden of these conditions."

Clinical Trials Demonstrate SOMA 250 mg Efficacy and Favorable Tolerability Profile

FDA approval of SOMA 250 mg was based on the results from two randomized, double-blind, placebo-controlled, multi-site parallel group studies (MP502 and MP505) which included more than 1,300 patients aged 18 to 65 who suffered from acute painful muscle spasm of the lower back. Results from both studies showed that SOMA 250 mg provided significant and rapid relief of back pain compared to placebo (P = 0.0001) with efficacy comparable to SOMA 350 mg.

Results from the studies also showed that SOMA 250 mg provided efficacy comparable to SOMA 350 mg with a more favorable tolerability profile, resulting in fewer discontinuations due to treatment-related adverse events. In the studies, the discontinuation rate due to adverse events for SOMA 250 mg was comparable to placebo and lower than that for SOMA 350 mg (2% versus 2.7% versus 5.4% respectively). The most common side effects associated with SOMA 250 mg in clinical trials included drowsiness (13%), dizziness (8%) and headache (5%). The most common side effects for SOMA 350 mg included drowsiness (17%), dizziness (7%) and headache (3%).

This new recommended dose of SOMA is 250 mg three times a day and at bedtime.

Important Information

SOMA (carisoprodol) is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. SOMA should be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful mu
'/>"/>

SOURCE MedPointe Pharmaceuticals
Copyright©2007 PR Newswire.
All rights reserved

3

GOOD

Page: 1 2 3

Related medicine news :

1. FDA approves Phase 0 trial which tests experimental drugs on humans
2. FDA Approves Contraceptive Ring
3. FDA approves new device to treat womens bleeding disorder
4. FDA Approves New HIV Drug, Viread
5. FDA Approves Birth Control Skin Patch
6. FDA approves surgical gel
7. FDA Approves New Arthritis Drug, Bextra
8. FDA Approves Elidel Cream for Eczema
9. FDA approves drug for rare liver disease
10. FDA approves first pocket-sized EKG machine
11. FDA Approves New Anti-Clotting Drug
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/16/2009)... Dec. 16 Medical travel facilitator Companion ... in Puerto Rico into its network of international ... lower than those at mainland U.S. facilities. ,, ... medical travel assistance and preferred pricing for its ... treatment at either HIMA San Pablo Bayamon or ...
(Date:12/16/2009)... MassMutual,s Retirement Services Division has announced plans to ... Q2 2010. The new platform will include a ... materials in a variety of themes. Plan sponsors ... menu of creative options to support the theme ... new RetireSmart participant engagement platform will be phased ...
(Date:12/16/2009)... century shrouded man found in a tomb on the edge ... proven case of leprosy. Details of the research will be ... , The molecular investigation was undertaken by Prof. Mark Spigelman ... Center for the Study of Infectious and Tropical Diseases at ... Kim Vernon of Lakehead University, Canada, Prof. Azriel Gorski of ...
(Date:12/16/2009)... methionine, an amino acid typically found in red ... and seeds, can possibly increase the risk of ... Temple researchers. , The researchers published their findings, ... in a mouse model of Alzheimer,s disease," in ... "When methionine reaches too high a level, our ...
(Date:12/16/2009)... and Global Market Expansion , ... Ramat-Gan, Israel (PRWEB) ... Analytics to Web sites and companies, today announced a record year ... Since its launch on July 2008, Kampyle has processed more ... amassed more than 30,000 customers in 191 countries., , ,Kampyle pioneered ...
Breaking Medicine News(10 mins):Health News:Hospitals in Puerto Rico Join Companion Global Healthcare's Network 2Health News:MassMutual to Launch New RetireSmart(SM) Participant Engagement Platform 2Health News:MassMutual to Launch New RetireSmart(SM) Participant Engagement Platform 3Health News:MassMutual to Launch New RetireSmart(SM) Participant Engagement Platform 4Health News:MassMutual to Launch New RetireSmart(SM) Participant Engagement Platform 5Health News:DNA of Jesus-era shrouded man in Jerusalem reveals earliest case of leprosy 2Health News:DNA of Jesus-era shrouded man in Jerusalem reveals earliest case of leprosy 3Health News:Diet high in methionine could increase risk of Alzheimer's 2Health News:Kampyle Experiences Record Growth in 2009 with 25,000 New Customers 2Health News:Kampyle Experiences Record Growth in 2009 with 25,000 New Customers 3Health News:Kampyle Experiences Record Growth in 2009 with 25,000 New Customers 4Health News:Kampyle Experiences Record Growth in 2009 with 25,000 New Customers 5
... and groups across the country and around the globe are ... period. The purpose of Men,s Health Month is to ... detection and treatment of disease among men and boys. The ... the week ending on Father,s Day, a special awareness period ...
... new study is the first to show that there ... liver disease in the general U.S. adult population. This ... disease in highly-exposed chemical workers. The study is being ... ), the largest international gathering of physicians and ...
... Advance Health Care Investment OpportunitiesCHICAGO, May 29 ... private equity firm focused exclusively on the health care ... to join the firm as a partner, effective July ... Mr. Womsley, 45, will work with Water Street,s team ...
... the immune system,s response, study with mice shows , , FRIDAY, ... that drugs that affect the immune system might one day ... swine flu that,s currently circulating around the globe. , ... that were treated with the rheumatoid arthritis drug abatacept (Orencia) ...
... 29 VION PHARMACEUTICALS, INC. ... of clinical data of its lead anticancer agent Onrigin ... presented in a poster at the 2009 American Society ... poster (Abstract #7050) entitled "Comorbidity Description Using the Hematopoietic ...
... and Treatment for Patients with Shorter Recovery Time -DALLAS, ... first revolutionary AccuraScope(TM) Discectomy and Neural Decompression ... back pain in Dallas this week. North American ... procedure in the Dallas/Fort Worth area. The surgery is ...
Other Medicine News:Health News:Join Men's Health Network in Celebration of Men's Health Month 2Health News:Join Men's Health Network in Celebration of Men's Health Month 3Health News:Environmental pollution increases the risk of liver disease 2Health News:Citi Private Equity Executive Joins Water Street Healthcare Partners 2Health News:Citi Private Equity Executive Joins Water Street Healthcare Partners 3Health News:Rheumatoid Arthritis Drug Might Fight Swine Flu 2Health News:Rheumatoid Arthritis Drug Might Fight Swine Flu 3Health News:Vion Pharmaceuticals to Present Data on Onrigin(TM)at the ASCO(R) Annual Meeting 2Health News:Vion Pharmaceuticals to Present Data on Onrigin(TM)at the ASCO(R) Annual Meeting 3Health News:Kenneth L. Reed, M.D. Performs First State of the Art AccuraScope(TM) Procedure in Dallas 2
(Date:12/16/2009)... Ill., Dec. 16 Naurex Inc., a ... depression and other CNS disorders based on its ... data presented at a major medical meeting showed ... and anxiolytic-like activity with no signs of the ... the NMDA receptor(1). The studies also showed ...
(Date:12/16/2009)... ChemoCentryx, Inc. today announced that it ... clinical trial of CCX354, an orally-bioavailable, novel, small ... chemokine receptor for the treatment of rheumatoid arthritis ... and selective antagonist of CCR1, a chemokine receptor ... as monocytes and macrophages, associated with the inflammation ...
(Date:12/15/2009)... Wis., Dec. 16 Cellular ... commercial launch of iCell(TM) Cardiomyocytes for use in ... industry. These human heart cells are designed ... of drug compound efficacy and toxicity screens, weeding ... the pharmaceutical pipeline process before significant time and ...
Breaking Medicine Technology:Naurex Inc. Announces Presentation of Preclinical Data Showing its Novel Mechanism NMDA Modulator Exhibits Robust and Rapid-Onset Antidepressant Activity With No Signs of Classic NMDA-Associated Side Effects 2Naurex Inc. Announces Presentation of Preclinical Data Showing its Novel Mechanism NMDA Modulator Exhibits Robust and Rapid-Onset Antidepressant Activity With No Signs of Classic NMDA-Associated Side Effects 3Naurex Inc. Announces Presentation of Preclinical Data Showing its Novel Mechanism NMDA Modulator Exhibits Robust and Rapid-Onset Antidepressant Activity With No Signs of Classic NMDA-Associated Side Effects 4Naurex Inc. Announces Presentation of Preclinical Data Showing its Novel Mechanism NMDA Modulator Exhibits Robust and Rapid-Onset Antidepressant Activity With No Signs of Classic NMDA-Associated Side Effects 5Naurex Inc. Announces Presentation of Preclinical Data Showing its Novel Mechanism NMDA Modulator Exhibits Robust and Rapid-Onset Antidepressant Activity With No Signs of Classic NMDA-Associated Side Effects 6ChemoCentryx Initiates Phase 2 Clinical Trial of CCX354 for the Treatment of Rheumatoid Arthritis 2ChemoCentryx Initiates Phase 2 Clinical Trial of CCX354 for the Treatment of Rheumatoid Arthritis 3ChemoCentryx Initiates Phase 2 Clinical Trial of CCX354 for the Treatment of Rheumatoid Arthritis 4ChemoCentryx Initiates Phase 2 Clinical Trial of CCX354 for the Treatment of Rheumatoid Arthritis 5Cellular Dynamics Announces Commercial Launch of iCell(TM) Cardiomyocytes for Drug Candidate Toxicity Screening 2Cellular Dynamics Announces Commercial Launch of iCell(TM) Cardiomyocytes for Drug Candidate Toxicity Screening 3Cellular Dynamics Announces Commercial Launch of iCell(TM) Cardiomyocytes for Drug Candidate Toxicity Screening 4Type 1 diabetes linked to immune response to wheat 54951 1Type 1 diabetes linked to immune response to wheat 54951 2Swine Flu Vaccine Delay Manageable Experts Say 54949 1Swine Flu Vaccine Delay Manageable Experts Say 54949 2Swine Flu Vaccine Delay Manageable Experts Say 54949 3MN Community Measurement Launches First Of Its Kind Quality Measure For Depression Care 54948 1MN Community Measurement Launches First Of Its Kind Quality Measure For Depression Care 54948 2MN Community Measurement Launches First Of Its Kind Quality Measure For Depression Care 54948 3
... The STA is a fully-automated, ... chromogenic and immunological assays in true ... method of sample management offers high ... samples without the need to interrupt ...
The ACL 9000 together with an extensive test menu and superior technology is backed by high-quality service to keep the lab running efficiently....
HemoSite meter can be used to measure the effects of transfusion or the treatment of deficiency states. It is fast, easy, convenient and discrete....
... The D-10 Hemoglobin Testing System delivers ... provides a fully automated system which combines ... single platform. Programs for rapid HbA1c or ... and can be easily integrated into your ...
Medicine Products: