Validive® (clonidine HCl MBT) is a novel mucobuccal tablet (MBT) formulation of clonidine. The mucobuccal tablet provides for prolonged local delivery of clonidine to the regions of oral mucosal radiation damage in oropharyngeal cancer (OPC) patients. The tablet is self-administered once daily in the patient’s home setting with the patient placing it under the upper lip where it adheres to the gums and dissolves over several hours, continuously releasing clonidine into the saliva. Clonidine agonizes the alpha-2 adrenergic receptor on macrophages (white blood cells present in the immune tissues of the oropharynx), decreasing the release of the destructive cytokines that are produced by macrophages in response to radiotherapy. A completed double-blind, randomized, placebo-controlled Phase 2 clinical trial showed:
- 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).