Validive (clonidine MBT) is a mucobuccal tablet (MBT) of clonidine based on the Lauriad® mucoadhesive technology. The Lauriad® technology was developed for oral transmucosal drug delivery and significantly increases the mucous and salivary concentrations of the active ingredient it contains with decreased systemic absorption. The tablet is placed under the patient's upper lip where it adheres to the gums for several hours, releasing the active ingredient into the saliva.
Validive is designed to deliver high local concentrations of the active pharmaceutical ingredient, clonidine, an agonist of alpha-2 adrenergic receptors (α2AR), to the oropharynx, the site of irradiation in the treatment of oropharyngeal cancer. In the oropharynx, α2AR are expressed on macrophages, a type of immune cell that produces cytokines, which are molecules that are responsible for the development of severe oral mucositis (SOM). A randomized, double-blinded Phase 2 trial confirmed Validive's mechanism of action and demonstrated:
- reduced incidence and duration of SOM
- improvement of oral mucositis-related symptoms
- decreased radiotherapy-related adverse events
- a safety profile similar to placebo
- strong compliance to treatment
Severe Oral Mucositis
Learn more about Severe Oral Mucositis (SOM).