Merck Research Laboratories developed a new drug, called
taranabant, which helped people shed pounds, but taken in higher quantities can
lead to gastrointestinal distress and psychiatric problems, scientists said.
"It suppresses food intake and increases your metabolism,"
explained Dr. Steven Heymsfield, global director of scientific affairs,
obesity, for Merck Research.
The pill is currently being tested in a far larger
late-stage trial whose results are expected to be unveiled later this year.
Taranabant, as well as Sanofi-Aventis’s rejected ribonabant,
works by blocking cannabinoid receptors in the brain, which receptors make
people hungry when smoking marijuana.
"When you block the cannabinoid system with an antagonist
like taranabant, you suppress appetite," said Heymsfield.
The study included 553 obese patients, who were divided in more
groups, which were administered 0.5,2,4 or 6 milligrams daily. The last group
was given placebo. The patients were followed for a period of 12 weeks. They also
followed a reduced-calorie eating plan but no specific exercise plan.
"Those who took the 6-milligram dose every day for 12
weeks lost about 11 pounds," Heymsfield said.
Those on placebo lost only 2.6 pounds he added.
The researchers discovered that people who took the drug ate
20 percent fewer calories than those who were given placebo. The drug also
increased resting energy expenditure or metabolism by 5 percent. The bad part
of the study is that 30 percent of people who received taranabant reported
psychiatric-related adverse events including depression and anxiety, compared with
18 percent in the placebo group. Larger amounts also led to stomach upsets,
nausea and vomiting and caused patients to become more irritable.
Taranabant comes second after Sanofi-Aventis’ rimonabant(Acomplia)
which was rejected by the Food and Drug Administration in the United States due
to concerns about the risk of suicidal thoughts among some users. However,
rimonabant is on the European market, being available in some countries. Its manufacturer
is facing two class-action lawsuits filed by investors because Sanofi allegedly
released misleading information about the depressive effects of the drug.
"In doses we're studying, we believe the drug can be effective in
weight loss, yet be safe," said Merck spokesperson Amy Rose.
However, she added that the safety of the drug would be checked in a larger
Phase III trial, as "we need to wait for reliable data." Rose said that much
data from the actual study was presented in October at a medical meeting in New Orleans.
According to the Centers for Disease Control and Prevention,
two-thirds of the U.S.
population is overweight or obese.
Merck’s representative Ian McConnell said last month that it
expects to file for marketing approval of the drug by the end of 2008.
"Two hundred million people could be candidates to take this drug. I think
the FDA is being very, very careful," said Raj Padwal, an assistant professor
at the University
of Alberta.
The study was published on Tuesday issue of the Cell Metabolism.
Merck, based in Whitehouse Station,
New Jersey, rose $1.74, or 3
percent, to $59.66 at 4:05 p.m. in New York Stock Exchange composite trading,
the biggest increase since October. The stock has increased 35 percent in the
past 12 months.