Flurbiprofen lozenges, the first locally acting, non-steroidal anti-inflammatory treatment for sore throats, have been launched by Crookes Healthcare (see p615).
Dr David Lott (medical officer, Crookes Healthcare) told The Journal on October 5 that he believed the lozenges would be appropriate for pharmacy-only status but this was not currently possible because flurbiprofen was classified as a prescription only medicine. Any decision to change this would rest with the Medicines Control Agency, he said, but in the meantime, Crookes planned to collect safety data and to apply for pharmacy-only status in the future. Safety data would be mainly collated through feedback from GPs, although there was a possibility of a study run through pharmacies, he said.
Data to support use of the flurbiprofen lozenges were provided in four main clinical trials carried out by the company. The trials indicated that flurbiprofen 8.75mg lozenges were effective and well tolerated. According to Crookes, the lozenges provided significant pain relief for at least two hours. Significant reductions in throat soreness and swelling occurred within 30 minutes and were sustained for at least three hours.
The first trial showed that doses above 5mg provided effective pain relief. Other trials used an 8.75mg flurbiprofen lozenge and compared its safety and efficacy to both placebo (demulcent) and positive control (higher strength, 12.5mg dose) lozenges. Treatment with flurbiprofen 8.75mg lozenges was shown to be significantly superior to placebo in terms of reducing throat swelling and pain. In addition, treatment outcomes with flurbiprofen 12.5mg lozenges were not significantly different from those with doses of 8.75mg.
In terms of safety, there were no serious adverse drug reactions in any of the trials. The most common side effect was taste perversion, usually described as a tingling sensation in the mouth. This was seen in between 7 and 26 per cent of patients using the 8.75mg lozenges, although rates were higher with the 12.5mg dose.