Navigation Links
Essentialis to Submit SPA for Hypertriglyceridemia
Date:8/11/2009

CARLSBAD, Calif., Aug. 11 /PRNewswire/ -- Essentialis, Inc., a clinical stage pharmaceutical company, announced today its intention to file a Special Protocol Assessment (SPA) with the FDA for the pivotal study to support the NDA filing on its lead drug, DCCR, for the treatment of very high triglycerides. The proposed study would include 280 randomized subjects with the primary efficacy endpoint assessed at 12 weeks. This decision followed a productive Type C meeting with the FDA on July 30th, where the overall development plan for DCCR and the non-clinical package supporting the NDA were reviewed and discussed. Commenting on this development, Essentialis President and CEO Iain Dukes stated, "The submission of the SPA will bring us one step closer towards filing for approval of DCCR for the treatment of patients with very high triglycerides. This development, along with positive Phase 2 study results and the recent issuance of a US patent providing extensive protection to DCCR, underscores the tremendous clinical and commercial potential of this drug worldwide."

About DCCR

DCCR, diazoxide choline controlled release tablet, is an ATP-sensitive potassium channel agonist which has potential therapeutic utility in several cardiovascular and metabolic diseases. Extensive Phase 1 testing has demonstrated the drug's potential to lower triglycerides (TG), non-HDL cholesterol and LDL-cholesterol (LDL-C) while raising HDL-cholesterol. In addition, weight loss has been demonstrated in 2 investigator sponsored studies. A Phase 2, 8-week, placebo-controlled, double-blind study involving 90 patients, which was powered to be pivotal, demonstrated statistically significant reductions in triglycerides, without impacting LDL-C. In subjects with elevated LDL-C at baseline, DCCR reduced LDL-C levels. DCCR was generally well tolerated, and most AEs were mild to moderate, resolving without sequelae. US patent 7,57
'/>"/>

SOURCE Essentialis, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Essentialis Meets Primary Endpoint in Phase 2b Trial of DCCR for Treatment of Hypertriglyceridemia and is Granted Extensive Patent Coverage in the US
2. Essentialis Completes Patient Enrollment in Phase 2 Trial of DDCR for Treatment of Dyslipidemia
3. Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA
4. Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder
5. PharmAthene Submits Proposal to BARDA in Response to Broad Agency Announcement for Advanced Research and Development for Valortim(R)
6. PharmAthene Submits SparVax(TM) Regulatory Strategy to FDA
7. Human Genome Sciences Submits Biologics License Application to FDA for ABthrax(TM)
8. Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever
9. D-Pharm Submits Investigational New Drug Application and Special Protocol Assessment to the FDA for Phase III Trial of DP-b99 in Acute Stroke Patients
10. AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product
11. U.S. Naval Medical Research Center Resubmits IND Application for Proposed RESUS Clinical Trial in Trauma Patients in the Out-of-Hospital Setting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... Ill., July 25, 2014 NOT FOR ... OR INDIRECTLY, IN, INTO OR FROM ANY JURISDICTION WHERE TO ... OR REGULATIONS OF SUCH JURISDICTION AbbVie (NYSE: ABBV ... June 30, 2014. "This was another very ... per share above our original guidance and announced plans to ...
(Date:7/24/2014)... , July 24, 2014  Parnell Pharmaceuticals Holdings ... that will be added to Parnell,s already extensive ... Pty Ltd, a biotechnology company. The compounds now ... shown promise in bone regeneration and dermal regeneration, ... the compounds for the veterinary market with the ...
(Date:7/24/2014)... and MARSEILLE, France , July 24, ... global license from University of Tokyo enables development of ... gene panels, for blood cancers  Mutations of ... favorable prognosis for patients with bone marrow disorders known ... developing companion diagnostics to guide treatment with new anti-cancer ...
Breaking Medicine Technology:AbbVie Reports Second-Quarter 2014 Financial Results 2AbbVie Reports Second-Quarter 2014 Financial Results 3AbbVie Reports Second-Quarter 2014 Financial Results 4AbbVie Reports Second-Quarter 2014 Financial Results 5AbbVie Reports Second-Quarter 2014 Financial Results 6AbbVie Reports Second-Quarter 2014 Financial Results 7AbbVie Reports Second-Quarter 2014 Financial Results 8AbbVie Reports Second-Quarter 2014 Financial Results 9AbbVie Reports Second-Quarter 2014 Financial Results 10AbbVie Reports Second-Quarter 2014 Financial Results 11AbbVie Reports Second-Quarter 2014 Financial Results 12AbbVie Reports Second-Quarter 2014 Financial Results 13AbbVie Reports Second-Quarter 2014 Financial Results 14AbbVie Reports Second-Quarter 2014 Financial Results 15AbbVie Reports Second-Quarter 2014 Financial Results 16AbbVie Reports Second-Quarter 2014 Financial Results 17AbbVie Reports Second-Quarter 2014 Financial Results 18AbbVie Reports Second-Quarter 2014 Financial Results 19AbbVie Reports Second-Quarter 2014 Financial Results 20AbbVie Reports Second-Quarter 2014 Financial Results 21AbbVie Reports Second-Quarter 2014 Financial Results 22AbbVie Reports Second-Quarter 2014 Financial Results 23AbbVie Reports Second-Quarter 2014 Financial Results 24AbbVie Reports Second-Quarter 2014 Financial Results 25AbbVie Reports Second-Quarter 2014 Financial Results 26AbbVie Reports Second-Quarter 2014 Financial Results 27AbbVie Reports Second-Quarter 2014 Financial Results 28AbbVie Reports Second-Quarter 2014 Financial Results 29AbbVie Reports Second-Quarter 2014 Financial Results 30AbbVie Reports Second-Quarter 2014 Financial Results 31AbbVie Reports Second-Quarter 2014 Financial Results 32AbbVie Reports Second-Quarter 2014 Financial Results 33AbbVie Reports Second-Quarter 2014 Financial Results 34AbbVie Reports Second-Quarter 2014 Financial Results 35AbbVie Reports Second-Quarter 2014 Financial Results 36
... SAN DIEGO, Oct. 29 NuVasive, Inc. (Nasdaq: ... products for minimally disruptive surgical treatments for the spine, ... Executive Vice President, will present at the Oppenheimer 20th ... New York, New York, on Tuesday, November 3, 2009. ...
... , This holiday season, settle your stomach, relieve your wallet ... for the holidays, when many of us may suffer from occasional ... Health finds that you probably don,t need an expensive drug ... new report uses comparative effectiveness research to identify "Best Buys" based ...
Cached Medicine Technology:NuVasive to Present at the Oppenheimer 20th Annual Healthcare Conference 2NuVasive to Present at the Oppenheimer 20th Annual Healthcare Conference 3Consumer Reports Health: Americans With Heartburn Paying Too Much Green For Nexium's 'Purple Pill' 2Consumer Reports Health: Americans With Heartburn Paying Too Much Green For Nexium's 'Purple Pill' 3
(Date:7/25/2014)... 25, 2014 SF Cable, internet distributor ... in stock and custom-made, delivered at the lowest prices ... announce the availability of its exclusive line of ... angle cables and adapters provide connectivity in the most ... Male A, Male B, Female and Mini 5pin. , ...
(Date:7/25/2014)... July 25, 2014 (HealthDay News) -- Twins, genes may ... environment, according to a new study. Researchers ... putting words together and grammar, were largely inherited. ... the "twinning effect" (a lower level of language performance ... twins than non-identical twins. "This finding disputes hypotheses ...
(Date:7/25/2014)... (PRWEB) July 25, 2014 The Europe ... solutions market in Europe with analysis and forecast of ... $13.53 billion in 2014 to $19.07 billion by 2019, ... , Browse through the TOC of the Europe Cyber ... in-depth analysis provided. It also provides a glimpse of ...
(Date:7/25/2014)... (PRWEB) July 25, 2014 “You have a ... than 500 people and their loved ones across the U.S. ... a brain tumor diagnosis is typically met with confusion and ... new and difficult vocabulary, and make critical decisions about a ... tumor diagnosis is accompanied by a sense of isolation and ...
(Date:7/25/2014)... The North America Artificial lift market report defines and segments ... forecast of revenue. The artificial lift market in North America ... to around $7 billion by 2018, at a CAGR of ... TOC of North America artificial lift market report, to get ... glimpse of the segmentation in North America Artificial lift market, ...
Breaking Medicine News(10 mins):Health News:SF Cable Presents Exclusive Custom 90° Angle USB Cables and Adaptors 2Health News:Genes May Be Key to Language Delay in Kids 2Health News:Europe Cyber Security Market is Expected to Reach $19 billion in 2019 - New Report by MicroMarket Monitor 2Health News:Europe Cyber Security Market is Expected to Reach $19 billion in 2019 - New Report by MicroMarket Monitor 3Health News:Europe Cyber Security Market is Expected to Reach $19 billion in 2019 - New Report by MicroMarket Monitor 4Health News:American Brain Tumor Association to Expand Service Reach with Launch of Nationwide Volunteer Network 2Health News:American Brain Tumor Association to Expand Service Reach with Launch of Nationwide Volunteer Network 3Health News:North America Artificial Lift Services Market is Expected to Reach $7 Billion in 2018 - New Report by MicroMarket Monitor 2Health News:North America Artificial Lift Services Market is Expected to Reach $7 Billion in 2018 - New Report by MicroMarket Monitor 3Health News:North America Artificial Lift Services Market is Expected to Reach $7 Billion in 2018 - New Report by MicroMarket Monitor 4
... Funnel Cancer Research to ... ... medical practices in Nevada and SW Utah will benefit from a,new ... Institute (NVCI). The new partnership,will provide resources to help local physicians ...
... new study in the Journal of Communication reveals that ... more than simply providing a list of URLs to accredited sites. ... the second leading cause of cancer death among women. Led by ... out to examine what type of access to internet resources would ...
... WORTH, Texas, July 15 Wound Management,Technologies, Inc., ... a new 510K on a new wound management ... new product (patent pending) will combine the hydrolyzed ... and,will initially be available in gel form. Hydrolyzed ...
... an association between certain past diagnostic radiation procedures and ... rare form of prostate cancer which affects about 10 ... , The study, the first of its kind to ... diagnostic procedures and the risk of prostate cancer, was ...
... Provides consistent information and streamlines service delivery to ... ... Lagan, a provider of enterprise,case management solutions that streamline the delivery ... Lagan Human Services(TM) to support the county,s e-Government,initiative for its Human ...
... survival, study finds , , TUESDAY, July 15 (HealthDay News) ... brain tumors called glioblastoma multiforme (GBM) may help boost ... new report says. , An article in the ... this would mark the first time a tumor-altering therapeutic ...
Cached Medicine News:Health News:Physicians Practice and Nevada Cancer Institute Partner to Improve Patient Care 2Health News:Physicians Practice and Nevada Cancer Institute Partner to Improve Patient Care 3Health News:Focused Internet services provide better support to breast cancer patients 2Health News:Wound Management Technologies, Inc. Announces Filing of a 510K 2Health News:Possible link found between X-rays and prostate cancer 2Health News:Hennepin County, Minnesota Selects Lagan Human Services(TM) to Support Human Services and Public Health Department e-Government Initiative 2Health News:Hennepin County, Minnesota Selects Lagan Human Services(TM) to Support Human Services and Public Health Department e-Government Initiative 3Health News:Brain Cancer Vaccine's Immune Response Key to Outcomes 2
Opti-One multi-purpose solution with citrate protein removal and advanced surfactant combination....
Light weight adjustable trial frame, adult...
Classic Trial Frames UB3 that has long set the standard....
Non Sterile surgical blade....
Medicine Products: