The Buckinghamshire, UK-based drugmaker is set to relaunch its methadone oral solution back onto the Norwegian, Swedish and Finnish markets over the next few weeks, through its commercialisation partner Unimedic AB.
The product, an opioid substitution therapy (OST), was withdrawn from the markets in 2014 following a recommendation by the European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) concerning the use of products containing high molecular weight povidone, a polymer added to the antiseptic ingredient in such drugs.
The Committee was concerned that if oral products were misused and injected by the patient, povidone could accumulate inside the cells of vital organs and cause serious harm.
“A number of products on the market were affected by this decision,” Michael Clark, Chief Marketing Officer at Martindale Pharma, told in-Pharmatechnologist.com. “[Our] product was impacted in Norway, Sweden and Finland and so we had to re-formulate, which we are very pleased to say has been achieved.”
Povidone is used as a suspending and dispersing agent in in oral solutions, and according to the firm the main alternative “contains ethanol at the concentration of 24 mg/ml meaning it is particularly unsuitable for individuals with a history of alcohol dependency or who wish to avoid consuming alcohol on a daily basis.”
The reformulated product is a 2mg/ml, orange flavoured, sugar-free oral liquid but Clark did not say what excipient replaces povidone.
Martindale Pharma’s methadone product in the UK, Physeptone, has a different formula and was not impacted by the suspension. According to labelling information, Physephtone contains Lycasin(r) 80/55, potassium sorbate, purified water and colours, along with the active ingredient.
The new formulation will be available from April 1 in Norway and Sweden and May 1 in Finland.