FDA APPROVES CESAMET TO TREAT NAUSEA AND VOMITING ASSOCIATED WITH CANCER CHEMOTHERAPY

Story Summary:

Valeant Pharmaceuticals International announced that the U.S. Food and Drug Administration (FDA) has given marketing approval for Cesamet™ (CII) (nabilone) oral capsules. Cesamet is used to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments.

Cesamet is a synthetic cannabinoid that is thought to act as an omnineuromodulator – interacting with the cannabinoid receptor, CB1, which is present throughout the nervous system. This receptor is involved in regulating nausea and vomiting. Because of this omnineuromodulation, the mechanism of action for Cesamet is significantly different from conventional anti-emetics. Cesamet has a long duration of action, which allows for less frequent dosing, typically twice daily.

The American Cancer Society estimates that there will be nearly 1.4 million new cancer cases in 2006. For patients on chemotherapy, stomach upset may occur and trigger a strong urge to vomit. Approximately 70 to 80 percent of all patients receiving chemotherapy experience chemotherapy-induced nausea and vomiting (CINV). Although the use of anti-emetic agents decreases the incidence and severity of CINV, symptoms continue to occur in 40 to 60 percent of patients.

Soundbites

• Neal Slatkin, Director of Supportive Care of Pain and Palliative Medicine, City of Hope National Medical Center
• Paul Daeninck, Oncologist and Palliative Care Physician, Saint Boniface Hospital and Cancer Care Manitoba, Winnipeg Manitoba, Canada

B-Roll Includes

• Cesamet product shots
• Doctor Footage

VIDEO PROVIDED BY: "Valeant Pharmaceuticals Internationa"