Swallowing bad news is never easy, but the latest development involving Decapinol, a widely touted ‘next generation’ mouthwash designed to tackle gingivitis, is making execs at Sinclair Pharma choke.

The US launch has stalled because its marketing and distribution partner, OraPharma, wants to add a preservative “to make the formulation more robust.” This is described by Mike Flynn, Sinclair’s ceo, as a “precautionary measure,” but he mysteriously offers no further detail. As a result, the launch won’t occur until next year.

A Sinclair spokeswoman Zoe McDougall, tells in-Pharmatechnologist the decision to add a preservative was taken “to protect against things not normally seen.” Such as? Sorry, wouldn’t say. But one can only imagine.

However, she insists, “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)… “(The US) is a very litigious-conscious society.”

“We are disappointed by this delay to the final stage of the launch process for the US,” Flynn says. “However, we are confident of OraPharma’s continuing commitment to Decapinol and the precautionary measures they are taking in reformulating the product, and we will be working with them to bring the new formulation to the market.”

Decapinol was approved in the US two years ago to treat gingivitis, dental plaque, and for the prevention of periodontitis, which is a severe form of gum disease. The product has been hype, as in-Pharmatechnologist notes, because it’s the first new product class in 30 years to enter the gingivitis market, which Sinclair argues is worth more than $600 million.

The product is registered as a medical device because the molecule delmopinol is not an active pharmaceutical ingredient because of its unique action, which works by preventing bacteria from being able to stick to things, such as the tooth surface, in-Pharmatechnologist explains. 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. Reformulation of the product was already underway as a joint project between the two companies, McDougall adds.