Why we do double blind studies!!!
More fuel to the eldepryl (selegeline) fire.
Drug shows little benefit
Alzheimer's drug shows little
difference than placebo
November 3, 1997: 9:17 p.m. ET
TAMPA, Fla. (Reuters) - Alzheimer's patients treated
with
Somerset Pharmaceuticals' selegiline transdermal
system
showed little difference from those given a placebo,
according to preliminary analysis of Phase III
trials.
Somerset Pharmaceuticals Inc. is a joint
venture between
Watson Pharmaceuticals Inc. (WPI) and Mylan
Laboratories
Inc. (MYL).
"We are clearly disappointed with these
preliminary
results, especially in light of a worldwide clinical
database
that suggested the positive value of selegiline in
Alzheimer's
disease, and which motivated us to conduct this
study," Dr.
Melvin Sharoky, president of Somerset, said in a
statement
issued Monday evening.
The company completed a 48-week Phase III
clinical trial
involving 406 patients in which Somerset's patented
selegiline transdermal system (STS) with placebo
therapy.
Somerset said it will await a full audited analysis
of the data,
including evaluation of a number of secondary
endpoints,
before deciding what, if any, future efforts will be
taken in the
study of Alzheimer's disease.
"We will be evaluating our data over the next
several
months in an effort to determine if any particular
subset(s) of
patients may have responded positively to the STS
treatment," Sharoky said.
In other product-development efforts with the
STS,
Somerset said it was awaiting the results from its
Phase III
trial in depression and has a Phase III trial under
way in
Parkinson's disease.
Somerset also began a Phase II clinical trial
in patients
with attention-deficit hyperactivity disorder (ADHD)
associated with Tourette's syndrome and a Phase II
trial in
HIV patients with cognitive impairment.
The results of all those trials should be
available next
year, the company said.
--
CHARLES T. MEYER, M.D.
Middleton, WI
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