FDA Panel Backs Approval Of GW's Remifentanil

On April 30, Glaxo Wellcome's new opioid analgesic Ultiva (remifentanil hydrochloride) was recommended for approval by the US Food and Drug Administration's Anesthetic and Life Support Drugs Advisory Committee.

After a day-long review of the application dossier, the panel agreed that the new drug should be approved for marketing as a new pain-killing agent for use "during anesthesia and monitored anesthesia care." They reviewed the clinical data as well as discussing the company's proposed labelling, including indications and the company's educational plans for anesthesia practitioners.

Remifentanil is an agonist at the mu opioid receptor, and is the first of this class of drugs, called esterase-metabolized opioids, to win through to this stage of development. The fact that remifentanil can be broken down by non-specific esterases found throughout the body means that the drug has a very short duration of action. Other opioid analgesics used in anesthesia are often metabolized in specific organ systems, and as a result their effects last longer. At first glance, a longer-acting painkiller may seem to be desirable. However, these drugs depress respiratory function, especially at the doses used to provide analgesia in the anesthetic setting, so a short duration of action is desirable for some procedures.