Delving into the Latest Updates on VIOKASE 16 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms-

Target-

Action-

Mechanism-

Therapeutic Areas

Nervous System DiseasesDigestive System DisordersEndocrinology and Metabolic Disease+ [1]

Active Indication-

Inactive Indication

Abdominal PainCerebral PalsyExocrine Pancreatic Insufficiency+ [2]

Originator Organization

Aptalis Pharma Export, Inc.

Active Organization-

Inactive Organization

Forest Laboratories, Inc.

AstraZeneca PLC

License Organization-

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. Our objective is to elucidate the role of Nexium in the control of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased ER visits and decreased hospital admissions for abdominal pain.

Start Date01 Feb 2009

Sponsor / Collaborator

University of Florida

[+1]

NCT00559052

/ CompletedPhase 2

An Open-Label Cross-over Study to Evaluate the Intraduodenal Delivery of Lipase, Protease and Amylase From Administration of VIOKASE16 in Chronic Pancreatitis Subjects With Exocrine Pancreatic Insufficiency (EPI).

EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI. The current treatment of EPI includes enzyme supplementation with porcine pancreatic enzyme concentrate, consisting mainly of lipase, amylase and protease. An enzyme preparation able to deliver appropriate enzyme levels to the duodenum instead of the mid gut or distal small bowel, would appear to be clinically efficacious for the treatment of steatorrhea in subjects with CP suffering from EPI.

Start Date01 Mar 2008

Sponsor / Collaborator

Axcan Pharma (Australia) Pty Ltd.

[+3]

100 Clinical Results associated with VIOKASE 16

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100 Translational Medicine associated with VIOKASE 16

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100 Patents (Medical) associated with VIOKASE 16

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100 Deals associated with VIOKASE 16

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cerebral Palsy	Phase 3	United States	Forest Laboratories, Inc.	30 Nov 2007
Cerebral Palsy	Phase 3	Canada	Forest Laboratories, Inc.	30 Nov 2007
Cerebral Palsy	Phase 3	Poland	Forest Laboratories, Inc.	30 Nov 2007
Cerebral Palsy	Phase 3	Slovakia	Forest Laboratories, Inc.	30 Nov 2007
Exocrine Pancreatic Insufficiency	Phase 3	United States	Forest Laboratories, Inc.	30 Nov 2007
Exocrine Pancreatic Insufficiency	Phase 3	Canada	Forest Laboratories, Inc.	30 Nov 2007
Exocrine Pancreatic Insufficiency	Phase 3	Poland	Forest Laboratories, Inc.	30 Nov 2007
Exocrine Pancreatic Insufficiency	Phase 3	Slovakia	Forest Laboratories, Inc.	30 Nov 2007
Pancreatitis, Chronic	Phase 3	United States	Forest Laboratories, Inc.	30 Nov 2007
Pancreatitis, Chronic	Phase 3	Canada	Forest Laboratories, Inc.	30 Nov 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01142128 (AZ, CTgov)	Phase 1	Abdominal Pain \| Pancreatitis, Chronic	12	esomeprazole magnesium (Nexium Alone)	ncusynkdjj(zqmncqeidj) = pxrbylojfc pgaurdykfz (nghmtnbyub, ncreqwsnbg - qpjljevrhh) View more	-	21 Feb 2013
				Placebo to Nexium (Placebo to Nexium, Alone)	ncusynkdjj(zqmncqeidj) = amnuxrkvyf pgaurdykfz (nghmtnbyub, updjvdnebj - zwpvfymypn) View more