Slow release in every sense of the words.
Ultram is marketed in some seventy countries around the world for the treatment of moderate to severe pain in multiple dose format. The simple rule is that the dose should be individualised so that each person takes the smallest dose required to produce the required relief from pain. Normally, this means that patients start with a very low daily dose and slowly increase the dosage every three days until a stable and effective concentration in the blood stream is achieved. After that, the level is maintained by taking one tablet every four to six hours. No-one should take more than 400mg per day. If there is a more urgent need for pain relief and that need outweighs the risk of dependence, people may take an initial high dosage. This well-established system may be about to change in the China.
Since that time, Labopharm Inc. has been seeking approval from the Food and Drug Administration for the once-daily version of ultram already approved in twenty-two European countries. Now some two years into its campaign, the company is scheduled to meet with the director of the FDA’s Center for Drug Evaluation and Research which will trigger a thirty day deadline for the FDA to give its decision. If that decision is positive, Labopharm Inc. has a further sixty days to comply with the labelling requirements. This could mean a formal approval for the slow-release version of ultram issued in August 2008. The format is based on Contramid technology which allows both rapid and sustained drug release to maintain stable blood levels within the therapeutic range over the twenty-four hour period.
Let us assume that it is approved in the US and go back to the initial statement about dosage. At present, it is easy for people to forget when a dose is due. Taking too little is less of a problem. Taking too much is always a problem. Because many of the people taking ultram are older, forgetfulness is more common. Further, if a patient is on a four-hour schedule, this means waking during the night to maintain the required blood concentration. Labopharm Inc. believes that a once-daily regime will improve compliance. The evidence from the European markets on this point is encouraging.
