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:9/17/2014)... The Food and Drug Administration (FDA) has ... consider: , 1. The appropriate indicated ... 2. The potential for adverse cardiovascular outcomes associated ... ongoing, an informally-organized litigation group subcommittee prepared a presentation ... therapy. Among others, ZKB attorney Michelle L. Kranz and ...
(Date:9/17/2014)... September 17, 2014 StartX , ... 12 companies raising rounds of funding at its Summer ... hundred investors and media, was the first such gathering ... next to the university. The presentations were delivered on ... to StartX-QB3 Labs, a 2,000 square foot life science ...
(Date:9/17/2014)... 2014 Cadiz Laser Spa offers ... procedures to clients throughout Central Texas. The newest ... Collagen Induction Therapy. Using the revolutionary Rejuvapen micro-needling ... help clients correct a wide variety of skin ... and Cadiz Laser Spa is currently offering a ...
(Date:9/17/2014)... News) -- Present-day Europeans are the descendants of ... to a new study. Previous research ... early European farmers. But, a new genetic analysis ... the descendants of Ancient North Eurasians. Nearly all ... ancestral group, researchers from Harvard Medical School said. ...
(Date:9/17/2014)... Steven Reinberg HealthDay Reporter ... uncovered a key factor to explain why antibiotic-resistant bacteria can ... DNA called plasmids appear to be the culprit. They can ... and some carry a gene that makes bacteria drug-resistant, a ... carry an antibiotic-resistant gene to a class of antibiotic called ...
Breaking Medicine News(10 mins):Health News:FDA Advisory Committee Holds Hearing on Testosterone Safety 2Health News:Stanford-affiliated StartX Showcases Startups, New HQ, and Growth of Stanford-StartX Fund 2Health News:Stanford-affiliated StartX Showcases Startups, New HQ, and Growth of Stanford-StartX Fund 3Health News:Stanford-affiliated StartX Showcases Startups, New HQ, and Growth of Stanford-StartX Fund 4Health News:Stanford-affiliated StartX Showcases Startups, New HQ, and Growth of Stanford-StartX Fund 5Health News:Stanford-affiliated StartX Showcases Startups, New HQ, and Growth of Stanford-StartX Fund 6Health News:Revolutionary Collagen Induction Therapy is Now Available at Cadiz Laser Spa 2Health News:Europeans Are Descendants of at Least 3 Ancient Human Groups: Study 2Health News:Europeans Are Descendants of at Least 3 Ancient Human Groups: Study 3Health News:Researchers Discover How Bacteria Resist Antibiotics in Hospitals 2Health News:Researchers Discover How Bacteria Resist Antibiotics in Hospitals 3
... new study has revealed that women diagnosed with breast ... exercise , then they should continue exercising, for ... ,Ohio State University researchers analysed 500 women, who had ... and more specifically the intensity and amount of physical ...
... smoking, by finding that regular smokers may have a higher ... never smoke. ,The study also found that while smokers ... in short run, this risk declines to the level of ... other words, both completely smoke-free life style and successful smoking ...
... is the biggest environmental issue no one's talking about," regrets ... founder of the Work Less Party, a Vancouver-based initiative aimed ... "As a society, we're working exponentially hard to decrease sustainability ... antidepressants are on the rise," he says. ,Americans ...
... it doesnt have to be that way always. ... that they have successfully managed to reduce wrinkles ... vitamin A. ,Not only did the cream ... people revealed it boosted levels of important skin repair ...
... an otherwise bleak healthcare scenario has emerged a heartening ... IM injection manufactured by the US based Institute for ... its Model List for Essential Medicines. ,Paromomycin ... (VL), the worlds second most deadly parasitic disease after ...
... prefer not to talk about, yet sufferers will go to ... overactive bladder (OAB) and it's characterized by a sudden ... ,Now, to reduce the symptoms of OAB, an Emory ... ankle to better help control the bladder. ,"Known ...
Cached Medicine News:Health News:Exercise may Help Breast Cancer Patients to Lead a Healthy Life 2Health News:Regular Smokers are at the Risk of Developing Depression 2Health News:Work Less to Sustain Planet Earth, Say Activists 2Health News:Work Less to Sustain Planet Earth, Say Activists 3Health News:Wrinkles can Be Really Ironed Out, Thanks to Vitamin A 2Health News:A Non-profit Drug Firms Injection to Fight Kala Azar Included in WHOs Model List 2Health News:A Non-profit Drug Firms Injection to Fight Kala Azar Included in WHOs Model List 3Health News:Stimulating the Ankle Can Help Patients With Overactive Bladder 2
(Date:9/17/2014)... OTEMR, Inc. , ONETOUCH EMR, 2.0 has achieved ONC ... the software is capable of supporting eligible providers with ... measures required to qualify for funding under the American ... certified on July 14, 2014 by ICSA Labs ... (ONC-ACB) and is compliant in accordance with applicable criteria ...
(Date:9/17/2014)... , Sept. 17, 2014  Members of ... and Interventional Associates announced today that the ... to enhance its image sharing capabilities and provide ... any network failures. In addition, the Dicom Systems ... navigate disparate PACS systems to more effectively deliver ...
(Date:9/17/2014)... , Sept. 17, 2014 Women everywhere ... infections are not only uncomfortable, they,re often also embarrassing ... plans. pH-D Feminine Health Support ( http://ph-defense.com ) is ... It is an all-natural, homeopathic product. ... common symptoms of vaginal infection. In many cases, the ...
Breaking Medicine Technology:OTEMR, Inc.'s ONETOUCH EMR Achieves ONC HIT 2014 Edition COMPLETE EHR Certification from ICSA Labs 2OTEMR, Inc.'s ONETOUCH EMR Achieves ONC HIT 2014 Edition COMPLETE EHR Certification from ICSA Labs 3Dicom Systems' Innovative Software Provides Enhanced Imaging Sharing Capabilities, as Well as Connection Reliability in the Case of Network Failure 2Dicom Systems' Innovative Software Provides Enhanced Imaging Sharing Capabilities, as Well as Connection Reliability in the Case of Network Failure 3New Product from Vireo Systems: pH-D Feminine Health Support 2
... The Vitros ECi brings true ... to immunodiagnostic testing. Highly sensitive assays ... oncology and bone metabolism testing are ... under development. The Vitros ECi can ...
... is a flexible system that ... environments small hospitals, backup ... satellite locations. The Vitros 250 ... can be automated or placed ...
... an effort to improve on the ... toxicology, abused drugs, and immunosuppressants tests, ... which incorporates random access capabilities. Although ... undergone several important changes in the ...
The IMx system is an automated analyzer designed to perform microparticle enzyme immunoassay (MEIA), fluorescence polarization immunoassay (FPIA) and ion capture technologies....
Medicine Products: