Cpmp

Basic trial design to show efficacy

Study subjects

Definition of weight loss

Randomized, double-blind, and placebo-controlled. Study subjects (both placebo and drug) should be given similar instructions in diet, exercise, behavior modification, and other lifestyle changes Moderately to markedly obese with a body mass index (BMI) of >30 for otherwise healthy individuals and BMI >27 for those with comorbid conditions 1. Demonstration that the drug effect is significantly greater than the placebo effect and the mean drug-associated weight loss exceeds the mean placebo weight loss by at least 5%

Randomized, double-blind, and placebo-controlled

BMI of >30 for otherwise healthy males and females; BMI > 27 for those with comorbid conditions 'Demonstration of a significant degree of weight loss of at least 10% of baseline which is also statistically greater than that associated with placebo'

2. Demonstration that the proportion of subjects who reach and maintain a loss of at least 5% of their initial body weight is significantly greater in subjects on drug than in those on placebo

The majority of drugs that have been approved over the years for the treatment of obesity have been the so-called anorexiants (also called anorectics or anorexigenics), i.e., compounds that decrease food intake. Most of these drugs have been structural variants of phenylethylamine and produce their anorexic effects by modulating one or more of the monoamine neurotransmitter systems, serotonin (5-HT), norepinephrine (NE), and/or dopamine (DA). The earliest of these compounds to be associated with weight loss was amphetamine sulfate (Benzedrine).4'5

6.18.6.2 Antiobesity Drugs that Act through Central Nervous System (CNS) Mechanisms

6.18.6.2.1 Currently marketed compounds

Safety concerns that have arisen for antiobesity drugs in recent years have resulted in a steadily diminishing number of approved compounds. Currently, in the US seven anorexiant drugs are approved/marketed for the treatment of obesity. These are summarized in Table 4. The structure of the prototypical compound phenylethylamine is included for comparison.

Table 4 Chemical structures of approved anorectic drugs

Generic name

Structure

Controlled substance class

US trade names

Year approved in US

Phenylethylamine

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