An evaluation of the anorectic activity in man of a sustained release formulation of tiflorex.

1 The effects of a slow release form of tiflorex (TFX-SR, formerly known as flutiorex), a new anorectic drug. on subjective measures of hunger, arousal, and mood, and on objective measures of food intake, critical flicker fusion, pupil diameter, pulse rate and blood pressure, were observed in a two-phase placebo-controlled, double-blind trial using six healthy female volunteers. 2 In Phase I of the trial a reduction in hunger after TFX-SR, significant compared with pre-drug values, was observed some five to seven hours after administration; no significant reduction in hunger occurred after placebo. In Phase II, a significant reduction in food intake occurred at a time corresponding to, and slightly later than, the subjective anorectic effect noted in Phase I. 3 TFX-SR produced no effect on pulse rate or blood pressure; it did produce some mydriasis. 4 There was no evidence of CNS stimulation after TFX-SR; the drug had no influence either on critical flicker fusion frequency or psychomotor performance. A reduction in subjective arousal was observed after three hours, but tiflorex caused no other significant change in subjective measures of arousal or mood. 5 Only slight sleep disturbance was reported; subjective reports of headache were more frequent after drug administration than after placebo occurring in seven out of twelve active drug exposures. Side effects were noted on eleven occasions after TFX-SR compared to five occasions after placebo.