Hi friends, yesterday i read news about acomplia weight loss drugs. It was suggested that
Merck & Co., which is developing a diet
drug that works by blocking the CB-1 receptor like Sanofi's diet pill
Acomplia (rimonabant), has begun a Phase III trial of its drug based on
a dosage far lower than what Sanofi is trying to get approved by the
U.S. Food and Drug Administration.
While
Sanofi is seeking approval of a 20 mg dose of rimonabant, and Pfizer is
testing a CB-1 receptor antagonist that seems to work best at a 15 mg
dosage, the highest dosage being tested in Merck's phase III trial is 2
mg. Merck, in three Phase II
studies still underway of the drug it now calls MK-0364, has been
testing 2 mg, 4 mg and 6 mg dosages of the diet drug against a placebo
with more than 5,600 participants.
It
now has launched a Phase IIb/III trial involving about 1,000
participants -- 400 of whom are getting the 2 mg dose, with 200 getting
a 1 mg dose, 200 getting a .5 mg dose, and 200 getting a placebo --
suggesting it has concluded that lower may be better. Merck,
which has had nothing to say publicly abouts its CB-1 receptor
antagonist, was shown a copy of this story and declined comment.
But
the consent forms Merck has had patients sign to participate in the
Phase III trial state that dosages of MK-0364 ranging from .5 mg to 600
mg or a placebo have been given in various trials to more than 6,000
participants. While most of these
participants were in Phase II trials as short as 12 weeks and as long
as two years, the number of patients involved in these studies gives
Merck a body of experience with CB-1 receptor antagonists -- and their
possible side-effects -- that rivals the clinical trial experience of
Sanofi.
With Acomplia stalled at
the FDA for reasons widely believed to be centered on concern over side
effects, it is interesting to note that many of the side-effects for
MK-0364 cited in the Merck consent form were similar to those reported
for rimonabant -- nausea, mood-swings, anxiety and depression.
But several other side-effects reported by Merck are worth noting.
One
patient, who as part of a dosing study apparently was given a single
100 mg dose of MK-0364, developed "a severe rash and itching, which are
symptoms of Stevens-Johnson syndrome (severe rash with blister-like
areas). This patient fully recovered after treatment with
corticosteroid therapy. . ."
In the three ongoing studies of the 2 mg, 4 mg and 6 mg dosages of MK-0364, Merck said:
- "Four
participants were diagnosed with depression and suicidal thoughts. The
study doctors considered these diagnoses serious, severe, and related
to the study drug."
- "Three
participants had seizures. One of these participants had a history of
surgery for a brain tumor; another participant had a history of
seizures, and the third participant had no history of seizures."
- "Two
participants have died. One participant died suddenly, and researchers
believe an abnormal heart rhythm played a part in the death. The study
doctor thought the death was 'possibly drug related.' The second
participant died from a severe blood infection, which the study doctor
thought was 'definitely not drug related.' "
