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Depomed
begins phase III trial for Metformin
Menlo
Park, Calif.
DEPOMed Inc announced the opening of the investigators’ meeting
for the company’s phase III clinical trial of Metformin GR.
The kickoff meeting for the trial is being held last week, just
prior to the annual meeting of the American Diabetes Association;
both meetings are being held in Philadelphia.
Metformin GR is DepoMed’s once-daily Metformin product for
type II diabetes which uses the Company’s proprietary gastric
retention technology. The phase III trial will be held at 60 sites,
all in the United States. Enrollment for the trial is expected to
begin in July 2001. Endpoints for the study will be safety and efficacy.
‘‘We are very excited to be moving ahead with the clinical
trials of our Metformin GR product, said John W Fara, Ph D, president
& CEO of DepoMed. ‘‘With our strengthened balance
sheet from the recent financing, DepoMed will be able to accelerate
clinical trials for its other products.’’
Data from the phase II trial of Metformin GR are undergoing final
analysis and are expected to be released in July. Positive interim
phase II results were previously announced in April 2001. DepoMed’s
Gastric Retention (GR) System is a patented oral drug delivery technology
designed specifically for drugs preferentially absorbed high in
the gastrointestinal tract.
Using normal physiological processes by which the stomach retains
large objects for further digestion, the GR System swells following
ingestion and is retained in the stomach for a number of hours,
while it continuously releases the incorporated drug at a controlled
rate to absorption sites in the upper intestinal tract. The controlled
release of the drug at the preferred absorption site optimises delivery
of the drug and potentially maximises its therapeutic benefits.
Upon completion of drug delivery, the GR System dissolves and is
completely and safely eliminated through the intestine.
DepoMed Inc, a development stage company, is applying its innovative
oral drug delivery systems to the development of novel oral products
and improved formulations of existing oral drugs.
BW HealthWire
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