Mucomel

Mucomel (SP13004) is a high-dose melatonin mucoadhesive oral gel developed by Spherium Biomed (now part of Ferrer) for the prevention and treatment of oral mucositis in cancer patients receiving chemo-radiotherapy or bio-radiotherapy. The drug works through a disease-modifying mechanism that restores the natural defense mechanism of mucosal integrity by protecting cells from oxidative stress and inflammation. It was developed under an exclusive license from the University of Granada, based on research identifying melatonin's protective role against mucosal damage. Clinical Phase I/IIa trials in head and neck cancer patients demonstrated that Mucomel significantly reduced the incidence and duration of severe oral mucositis. The formulation is designed to adhere to the oral mucosa, providing a local protective barrier and delivering the active ingredient directly to the affected tissue.