Methodology of monitored release of a new preparation: buprenorphine.

The analgesic agent Temgesic (buprenorphine) was made available under monitored release regulations for one year, which yielded data from 1736 doctors on 9123 patients. An analysis of 17 120 administrations of the drug confirmed the results of the pre-licensing clinical studies encompassing data from nine British hospitals on 483 patients. No important new adverse effects attributable to the product were observed, and apart from giving reassurance, the usefulness of monitored release is questioned in the light of the relatively small amount of additional information arising from it.