UK-based speciality pharmaceutical company Sinclair Pharma announced today the company's US marketing and distribution partner for the product, OraPharma, had decided to explore adding a preservative to the US product "to make the formulation more robust" .
The move comes at a time when Decapinol (delmopinol hydrochloride), a new chemical entity for the treatment of gingivitis, is in the middle of its US launch, which now delays the launch in the US until at least 2008.
Speaking to in-PharmaTechnologist.com, Sinclair spokeswoman Zoe McDougall said the decision to add a preservative was a "precautionary measure" by OraPharma "to protect against things not normally seen" ; details of which were undisclosed.
"There are no problems with the product . . .
The existing standard of the product is fine, but they want to improve it from the existing standard . . .
It's a precautionary, not a necessary [decision]" she said.
"It's [the US] a very litigious, conscious society."
Decapinol was approved for the US in 2005 as a treatment for gingivitis (gum inflammation) and dental plaque, and for the prevention of periodontitis (a severe form of gum disease).
The product has had much hype, as it is the first new product class to enter the gingivitis market, worth more than $600m in the US, for 30 years, according to Sinclair.
The product is registered as a medical device because the molecule delmopinol is not an active pharmaceutical ingredient per se because of its unique action, which works by preventing bacteria from being able to stick to things, such as the tooth surface.
By interfering with glucans, molecules that form scaffolding on tooth surfaces which enhance bacterial colonisation, Decapinol creates a barrier on the teeth and gums, preventing the adhesion of bacteria.
At the same time, the product promotes a healthy balance of "good" bacteria in the mouth by having a low antimicrobial action, unlike conventional mouthwashes which indiscriminately kill all or most of the oral bacteria.
The Decapinol product currently marketed in Italy and Israel contains no preservative.
The US reformulation would not affect Decapinol in these jurisdictions at this point.
Both parties would be collaborating closely on the project .
The new formulation and preservative could not be disclosed.
In a statement, Sinclair chief executive Dr Michael Flynn said: "We are disappointed by this delay to the final stage of the launch process for the US.
However, we are confident of OraPharma's continuing commitment to Decapinol and the precautionary measures they are taking in reformulating the product."