2 February 2003

Sugar-free methadone acceptable to a majority of patients

Byrne A. Methadone ‘solution’ (Biodone) survey. APSAD Annual Conference, Wesley Centre, Sydney. October 2001 p41 (published conference abstract)

METHADONE 'SOLUTION' (BIODONE) SURVEY

INTRODUCTION: In November 2000 a new formulation of methadone became available in Australia, a red coloured, solution without the sugars, preservative, gum and alcohol of the current syrup. Patient responses have shown a low level of satisfaction with the existing product and it is not necessarily safe from a dental point of view. Comments on the flavour such as 'disgusting' and 'foul' have been made.

In some patients, side effects such as dyspepsia, vomiting and reflux are given as reasons for patients either dropping out of treatment or taking inadequate doses to abolish cravings for 24 hours. Such patients may be assisted by an alternative formulation.

METHODS: We offered the new methadone 'solution' to 125 patients (31 female, 82 male) who had been receiving the 'syrup' prescribed at an inner city dependency practice. Most patients received their medication at the Redfern practice while 14 (11%) attended a variety of pharmacies and clinics. Patients were surveyed about whether it was preferred and if any changes were noted after taking the new preparation.

RESULTS: The new 'solution' was tried by 116 (93%) at least once. The preparation was preferred by 57 (46%) patients with a further 24 (19%) having no preference. Thirty five patients (28%) sought to return to the 'syrup' product, finding the solution unacceptable, largely because of the foul taste. Many patients described the taste as being unpleasant, but that it went away more rapidly than with the syrup.

For those on high dose (>150mg daily, n = 30) the acceptance rate was higher, 60% favouring the new formulation. For those on less than 80mg, the rates were almost evenly divided into thirds: (1) favouring the Biodone solution, (2) favouring the Glaxo syrup and (3) no preference.
Reports from 6 patients indicated that clinically significant side effects from the syrup were either completely or largely abolished with the solution. These included morning sickness, reflux, dyspepsia and a 'heavy' feeling in the upper abdomen after dosing.

Four patients (3%) reported that the new solution did not seem to last as long and withdrawal symptoms occurred prior to 24 hours. This was addressed by increased dose in one case, splitting doses in another, returning to the syrup in one case. The fourth case persevered with the symptoms which settled after a number of weeks.

DISCUSSION: It is possible that sorbitol, alcohol and the other constituents of the 'syrup' may impede absorption in some cases. The 'non-core' constituents may be responsible for reducing gastric emptying time, thus increasing the effective half-life. The simple 'solution' thus may be absorbed faster in some cases and its elimination slightly faster. The syrup is thought to induce nausea and vomiting in some cases since changing to the simple solution caused such symptoms to cease in several cases.

CONCLUSIONS: It is recommended that all patients who have symptoms from the current formulation are given access to the new water based solution ('Biodone Forte'). If experience proves positive in practice, the benefits of a sugar-free medicine should be a consideration for all patients.