Schering-Plough UK have announced the immediate availability of Suboxone® (buprenorphine hydrochloride / naloxone hydrochloride) sublingual tablets for maintenance treatment of opioid dependence, within a framework of medical, social and psychological treatment.
Current standard maintenance therapies in the UK are methadone and buprenorphine, both of which bind to the opioid receptors in the brain. Suboxone includes naloxone alongside buprenorphine which is designed to limit the potential for misuse and potentially lower the street value and the incentive for diversion.
Misuse and diversion of maintenance therapies remains a significant problem for individuals and the wider community. Some patients take their medication by a route other than that prescribed in order to increase its euphoric effect (misusing it), and others may try to sell on their prescriptions (diverting them) or take medication for which they have not been prescribed, sometimes with fatal consequences. In a recent survey, 76% of opioid dependent patients receiving treatment were aware of methadone diversion in their community, with 55% also being aware of buprenorphine diversion .
Suboxone may, in time, reduce the costly burden of supervising patients daily whilst they take their medication. When taken sublingually (as prescribed), the naloxone component of the treatment has no effect, owing to its poor bioavailability through this route. However if injected, the naloxone component will be activated, causing precipitated withdrawal symptoms which makes the drug unattractive for misuse.
“Opioid dependence is a chronic, relapsing medical condition that requires long-term treatment and patient support”, explained Gordon Coutts, General Manager, Schering Plough UK & Ireland. “Suboxone was expressly designed to combine the proven effectiveness and tolerability of buprenorphine with a lower potential for misuse, underlining our commitment to this therapy area,” he continued.
Drug dependence is an enduring issue in the UK, with over 281,000 problem users of opioids in England alone . Heroin is the most frequently reported illegal drug of misuse - over two-thirds (67%) of people seeking treatment for drug dependency list it as their problem drug . Currently, it is estimated that 55% of problem drug users are not being treated for their addiction2, . On top of the long-term health impact of illicit substance misuse, injecting drug use can lead to the transmission of serious blood-borne diseases such as HIV and Hepatitis C .
“The addition of new treatments for heroin addiction is welcomed by the patient community. More choice for people trying to control or stop using opioids can only be a good thing.”, explained Daren Garrett, Executive Director of The Alliance, a user led organisation which provides advocacy, training and helpline services to those currently in drug treatment, those who have accessed drug treatment in the past and those who may access drug treatment in the future.
EMEA approval of Suboxone in late 2006 was based primarily on results of a one-year clinical trial in opioid-dependent patients, comprising a 4-week randomised double-blind comparison of Suboxone, buprenorphine monotherapy and placebo tablets followed by a 48-week safety study of Suboxone6. The primary study comparison was to assess the efficacy of Suboxone and buprenorphine individually versus placebo. In the study, Suboxone demonstrated similar efficacy and safety to buprenorphine, with a significantly higher percentage of urine samples taken three times during a week testing negative for non-study opiates for both Suboxone versus placebo and buprenorphine versus placebo. The reported adverse events during the study for Suboxone were similar to those seen with buprenorphine monotherapy and were those generally seen with other opioid-agonist treatments (e.g., headache, withdrawal syndrome, insomnia).
In a recent meeting, a team of multidisciplinary professionals discussed the strengths and weaknesses of current management pathways. They underlined the need to tailor therapies to suit patient needs and circumstances. Dr Michael Farrell, consultant Psychologist at the National Addiction Centre explained: “There are many issues which affect the successful management of people, these include access to treatment, restrictions imposed by perceived safety and cost, supervision and the impact of treatment both on the individual being treated and on the health service. New treatment options which help address some of these issues will be welcomed by the medical community.”
For further information contact:
Chandler Chicco Agency
151 Shaftesbury Avenue
London WC2H 8AL
Tel: 020 7632 1839
Fax: 020 7632 1801