Flupirtine: the first Italian experience.
This paper reports the results of five single-dose short-term, controlled clinical trials conducted in Italy with the structurally new analgesic flupirtine. A total of 200 patients were enrolled in the trials. One hundred and two patients received flupirtine, 61 were treated with reference drugs (suprofen and paracetamol) and 37 were on placebo. Analgesic efficacy was evaluated in post-episiotomy pain (2 studies and 70 patients), post-traumatic pain (2 studies and 100 patients) and in 30 post-operative patients. Flupirtine was given as a single dose of 100 mg (one capsule) or as a single day's treatment (100 mg t.i.d.). For suprofen and paracetamol, oral doses of 200 mg and 500 mg respectively were used. A semi-quantitative four- or five-point scale or a linear analogue scale was used to determine the degree of pain. In post-episiotomy pain, the time required to achieve a reduction of 50% of the initial pain was also used. In post-operative pain, flupirtine induced a 69% reduction in the pain score 6 hours after administration, compared with 26% in the placebo group. In post-episiotomy pain and pain due to sport injury, flupirtine showed greater efficacy as judged by the number of patients reporting good and acceptable pain relief, and a faster onset of pain relief than suprofen (episiotomy) or paracetamol plus massage (sport injury). The adverse reaction, nausea, was complained of once only during treatment with flupirtine.