Drug delivery company Monosol Rx and partner Reckitt Benckiser Pharmaceuticals have received US Food and Drug Administration (FDA) clearance to market a sublingual film formulation of the opioid dependence treatment Suboxone.
The product uses Monool’s PharmFilm technology to deliver the drug actives, buprenorphine and naloxone, through the lining of the mouth in a way that Reckitt Benckiser spokeswoman Harriet Ullman claimed “helps patients stay in treatment and reduce illicit opioid use by suppressing opioid withdrawal symptoms and reducing cravings.”
Ullman told in-pharmatechnologist that product, which will be available in US pharmacies from October 2010, is clinically interchangeable with Suboxone tablets, adding that patients in a recently completed clinical trial indicated they preferred the film formulation.
Monosol, which will manufacture the newly-approved film formulation on Reckitt’s behalf, claimed that the technology is “more stable, durable and quicker dissolving [under the tongue] than conventional dosage forms.”
Reckitt will market the drug to physicians across the US as part of a complete treatment plan for opioid dependence that includes counselling and psychosocial support.
MonoSol claim that its film technology, which is a similar size and thickness to a postage stamp, can carry both low doses of prescription products as well as larger doses of up to 80mg.
This, it claimed, improves dosing accuracy when administering drugs to paediatric, geriatric and neurodegenerative disease patients where precise dosing can pose a challenge.
MonoSol CEO Mark Schobel lauded the collaboration with Reckitt as example of the success of his firm’s partnering model, explaining that: “the value PharmFilm technology delivers to leading pharmaceutical companies further validates the commercial potential of film drug delivery for this industry.”
Ullman agreed, telling in-pharmatechnologist that: “Our expectations for the future are to continue working with healthcare providers to meet the clinical needs of individuals dependent on opioids.”
PharmaFilm is already the subject of a number of collaboration deals, the most recent of which, its deal with Applied Pharma Research, sees the firms team on developing film formulations of a number of existing drug products.