Navigation Links
Napo Obtains Special Protocol Assessment Agreement From FDA for Crofelemer

Napo Pharmaceuticals, Inc., which focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners , today announced that under the Special Protocol Assessment (SPA) process it has obtained agreement with the United States Food and Drug Administration (FDA) for the design of its pivotal study protocol for crofelemer for the treatment of chronic diarrhea in people with HIV/AIDS (CRO-HIV).

The study, also referred to as the ADVENT trial, will be carried out under an FDA Fast Track designation. On Jan. 16, 2007, Napo met with the FDA under the Special Protocol Assessment Process on this adaptive design of its ADVENT trial. On March 14, 2007, Napo announced it had received approval from the principal independent review board (IRB) overseeing the ADVENT trial.

The ADVENT trial -- (Anti-Diarrhea therapy in HIV disease-Emerging treatmeNT concepts) is a randomized, double-blind, parallel-group, placebo- controlled, two-stage, adaptive design study to assess the efficacy and safety of crofelemer at 125mg, 250 mg and 500 mg oral doses twice daily (p.o.b.i.d) for the treatment of HIV-Associated Diarrhea.

The 'adaptive design' of the ADVENT trial -- Adaptive trial design has been advocated by the FDA to improve efficiency of clinical trials. The ADVENT trial will be executed in two stages. Stage I represents a dose selection stage and Stage II, a dose assessment stage. Four dose groups (placebo, 125 mg, 250 mg, and 500 mg) will be assessed in Stage I. When 50 subjects per group complete the initial efficacy dosing period (28 days), an interim analysis will be conducted to select an optimal single dose of crofelemer for Stage II. Stage II will continue until an additional 75 subjects are randomized both to this dose of crofelemer and the placebo, providing for 125 patients on placebo and 125 patients the selected crofelemer dose. The primary study analysis is
'"/>




Page: 1 2

Related medicine news :

1. Special proteins to fight TB identified
2. Special proteins to fight TB identified
3. Specialist care convalesces intensive care survival
4. Specialist surgeon not imperative in melanoma
5. Treating Dental Problems Of Abused Children Need Special Care
6. Specialized Clinics For Manipurs AIDS Patients
7. Credentials Of Specialists Need To Be Checked
8. All Specialty Care Treatments Will Be Offered At Belle Vue.
9. Details of Cosmetic Surgery in a Special Website.
10. Omega-3 May Help Special Children
11. Inhospitable Response Curtail Growth Of Specialty Hospitals: United States
Post Your Comments:
(Date:7/30/2014)... ... ... ... , UCLA researchers interviewed people with diverticulitis and confirmed that many suffer psychological and physical symptoms ... Research , a UCLA team led by Dr. Brennan Spiegel interviewed patients in great detail about the symptoms they experience weeks, months ...
(Date:7/30/2014)... 2014 Over 630 doctors worldwide are ... the revolutionary minimally invasive treatment for gum recession. Santa ... of his peers to be the “father of microsurgery” ... recent Chao Pinhole Surgical Technique® training course at the ... the recipient of the American Academy of Periodontics (AAP) ...
(Date:7/30/2014)... 30, 2014 The American Telemedicine ... Sens. Thad Cochran (R-MS) and Roger Wicker (R-MS) ... telemedicine coverage under Medicare, Medicaid and Federal Communications ... Mississippi Republicans, introduced the Telehealth Enhancement Act as ... version, H.R. 3306, introduced by Rep. Gregg Harper ...
(Date:7/30/2014)... (PRWEB) July 30, 2014 The Institute ... is pleased to announce that Arianna Huffington has joined as ... of the Health Coach Training Program . , Arianna ... Post, a world-renowned news and blogging site that won a ... author of fourteen books and was included on the Forbes ...
(Date:7/30/2014)... (PRWEB) July 30, 2014 Frozen shoulder (Adhesive ... more likely to develop this nasty condition which occurs most ... and can last up to two and half years if ... frozen shoulder, and with good reason: it can render your ... — that is, if you aren't in too much pain ...
Breaking Medicine News(10 mins):Health News:Diverticulitis patients reveal psychological, physical symptoms long after acute attacks 2Health News:Diverticulitis patients reveal psychological, physical symptoms long after acute attacks 3Health News:Periodontist Dr. Dennis Shanelec Comments On The Chao Pinhole Surgical Technique® Training Course 2Health News:ATA Applauds Senators’ Push for Federal Telemedicine Improvements 2Health News:Arianna Huffington Joins Integrative Nutrition as a Guest Speaker 2Health News:Arianna Huffington Joins Integrative Nutrition as a Guest Speaker 3Health News:Good News for Diabetics Suffering from Frozen Shoulder 2Health News:Good News for Diabetics Suffering from Frozen Shoulder 3Health News:Good News for Diabetics Suffering from Frozen Shoulder 4
... CITY, Mo., June 19 President Emeritus of The Joint Commission, ... of Directors at the June 2009 meeting. , , ... Individual Achievement for his outstanding work during his tenure as President ... to have Dr. O,Leary join our Board of Directors," said TMC ...
... After recent ... as Reloxin, as a procedure on their website. , ... Houston, TX (PRWEB) June 19, 2009 -- Dysport (TM), a ... recently gained FDA approval and is expected to start hitting physicians, shelves in July, 2009. ...
... ... the 26th Annual ASMBS scheduled for June 21-26 in Dallas, TX. , ... Irvine, CA (PRWEB) June 19, 2009 -- Bariatric ... Annual ASMBS scheduled for June 21-26 in Dallas, TX. "The new products have been ...
... End of Health Coverage , , OAKLAND, Calif., ... National Nurses Organizing Committee/California Nurses Association -- which is ... reaction to the release of the GOP health proposal, ... health coverage, and force them into the individual market ...
... private corporations and average citizens sending money to their ... funding, according to a new study by the Institute ... of Washington. The research shows that funding for ... two decades from $5.6 billion in 1990 to ...
... of exotic animals like reptiles and birds need to be ... humans, according to a Kansas State University veterinarian. ... in K-State,s College of Veterinary Medicine, said exotic animals can ... factors to consider before owning one. , , West ...
Cached Medicine News:Health News:Joint Commission President Emeritus Joins Truman Medical Centers' Board of Directors 2Health News:Joint Commission President Emeritus Joins Truman Medical Centers' Board of Directors 3Health News:Dysport Added as a Procedure on AmericanHealthandBeauty.com: Let the Wrinkle Wars Begin 2Health News:Dysport Added as a Procedure on AmericanHealthandBeauty.com: Let the Wrinkle Wars Begin 3Health News:Bariatric Advantage to Introduce Ten (10) New Products at ASMBS 2Health News:Global health funding soars, boosted by unprecedented private giving 2Health News:Global health funding soars, boosted by unprecedented private giving 3Health News:K-State Veterinarian Says Although Exotic Pets Can Be Great Companions, There Are Health Factors That Can Affect Both the Animal and Humans 2Health News:K-State Veterinarian Says Although Exotic Pets Can Be Great Companions, There Are Health Factors That Can Affect Both the Animal and Humans 3
(Date:7/30/2014)... ARBOR, Mich. , July 30, 2014 Advanced ... first quarter (ending June 27, 2014) financial results on Monday, ... will be released after the close of the market and ... discuss the results at 4:30 p.m. EDT on the same ... Richard Kurtz (CEO and Director), Rob Risser ...
(Date:7/30/2014)... , July 30, 2014 In conjunction with ... 2014 financial results press release, you are invited to ... live over the internet on Thursday, August 7, 2014 ... A live audio webcast of the presentation ... http://www.durect.com and clicking "Investor Relations."  If you are ...
(Date:7/30/2014)... July 30, 2014 Research and Markets has ... - Forecasts to 2019" report to their offering. ... estimated to grow at a lower CAGR in developed countries; however, ... as China , India , ... The growth of the hematology analyzers and reagents market ...
Breaking Medicine Technology:Advanced Photonix to Webcast Fiscal 2015 First Quarter Earnings 2DURECT Corporation Invites You to Join its Second Quarter 2014 Earnings Conference Call 2Hematology Analyzers & Reagents Market - Forecasts to 2019 2
... interventional cardiology, accurate lesion assessment ... in determining the appropriate stent ... Cardiac 3-D (IC3D), a highly ... clinicians are now able to ...
... versatile solution designed to optimize the workflow ... to diagnosis and therapy, for both diagnostic ... your cath lab becomes an integral part ... free to concentrate on what really matters: ...
... FC is a floor-mounted, single ... system architecture for vascular and ... flexible and ergonomic system architecture ... the system configuration to focus ...
The ACUSON Sequoia C512 system elevates imaging and Doppler performance through new, high-density acoustic sampling, precise control of the transmitted acoustic waveform, and new transducer technolog...
Medicine Products: