Health Canada Approves Cuvposa to Treat Severe Drooling in Kids with Cerebral Palsy

Health Canada has approved Cuvposa (glycopyrrolate) to treat chronic severe drooling in children aged 3 to 18 years old with cerebral palsy (CP) and other neurological conditions.

Montreal-based Pediapharm developed Cuvposa to address excessive the saliva production — also known as sialorrhea — often found in children with CP, as well as in those with autism spectrum disorders, traumatic brain injuries or metabolic disorders.

An estimated 25 to 35 percent of kids with CP drool to varying degrees, and about 10 percent of them suffer from chronic severe drooling. Pediapharm says its total Canadian market for the drug — available as a 1 mg/5 ml cherry flavored oral solution — is about 5,000 patients.

Glycopyrrolate is a competitive inhibitor of acetylcholine muscarinic receptors located on peripheral tissues like salivary glands. The drug indirectly reduces the amount of saliva by inhibiting the stimulation of these receptors.

For Pierre Marois, pediatric physicist at Montreal’s Ste-Justine Hospital, excessive production of saliva is often underestimated and can have hurt the overall health of children with CP and other neurological conditions.

“Due to the limited treatment options available, sialorrhea is an all-too-often poorly managed condition in pediatric patients” Marois said in a press release. “Cuvposa is an important advancement in the treatment of chronic severe drooling in children with neurologic disorders.”

Merz North America, one of Pediapharm’s partners, acquired Cuvposa in 2012. Although Cuvposa already had U.S. approval, Merz succeeded in increasing awareness of the possibility to treat chronic drooling.

According to Great Britain’s first guideline on managing CP in children, adolescents and young adults, published earlier this year, managing feeding and drooling problems as well as supporting speech, language and communication are among the most important recommendations to guarantee that CP patients receive the care they need, so they can be as active and independent as possible.

The guideline, “Cerebral palsy in under 25s: assessment and management,” was published by the British government’s National Institute for Health and Care Excellence (NICE). The agency also plans a separate guideline on managing CP in adults for publication in early 2019.

“The approval of Cuvposa in Canada is another example of how we are guided by our mission to improve the health and well-being of Canadian children,” said Richard Labelle, Pediapharm’s vice-president of sales and marketing. ”Cuvposa represents a unique opportunity to introduce innovation for children with CP, many of whom are facing the burden of chronic severe drooling on a daily basis.”