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Validive (Clonidine Lauriad) Receives ‘Fast Track’ Designation for Prevention and Treatment of Oral Mucositis Induced by Anticancer Treatments

Mucoadhesive tablet delivers clonidine in the mouth (January 23)

Validive (clonidine Lauriad, BioAlliance Pharma) has received a “fast track” designation from the FDA for the prevention and treatment of oral mucositis induced by radiotherapy and/or chemotherapy in cancer patients.

The “fast track” procedure is designed to optimize the development time and review period for drugs investigated as treatments for serious or life-threatening diseases with a high unmet medical need.

Severe oral mucositis is a disabling condition induced by intensive radiochemotherapy protocols, which are particularly frequent in patients treated for head-and-neck cancers. At the severe stage, mucositis induces intense oral pain and eating disability requiring enteral or parenteral nutritional support. Hospitalization is needed in about 30% of patients, and symptoms can lead to anticancer treatment breaks or delays, which can affect the overall chance for successful treatment. No curative or preventive treatment is currently available.

Validive (clonidine Lauriad) is a mucoadhesive tablet that delivers high concentrations of an anti-inflammatory agent (clonidine) directly in the mouth, the site of irradiation in the treatment of head-and-neck cancers.

Source: BioAlliance Pharma; January 23, 2014.

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