Study Suggests Long-acting Patch that Prevents Nausea and Vomiting Can Be Given in Combination with Intravenous Medication
Use of a combination of Sancuso® (granisetron transdermal system; a patch that delivers granisetron through the skin for up to five days) and intravenous granisetron appears to be safe and feasible. This approach may provide immediate and extended management of chemotherapy-induced nausea and vomiting. The results of this Phase I clinical trial were presented at the Fifth Annual Chicago Supportive Oncology Conference.
Nausea and vomiting are among the most feared side effects of chemotherapy. Without effective prevention, these symptoms can have a dramatic impact on quality of life and physical and emotional well being. Fortunately, the development of more effective antiemetic (antivomiting) drugs has reduced the occurrence of chemotherapy-induced nausea (CINV) and vomiting. Antiemetic therapy often starts before chemotherapy begins, and continues for as long as the risk of nausea persists.
Several different types of antiemetic therapy are available. In order to achieve the most complete control of nausea and vomiting, patients may receive a combination of antiemetic drugs.
Sancuso is a patch that delivers the antiemetic medication granisetron through the skin. Each patch works for up to five days to reduce the risk of CINV.
To evaluate the feasibility of administering Sancuso along with intravenous (IV) granisetron, and of administering a second Sancuso patch after the first is removed, researchers conducted a Phase I clinical trial. The goal of these treatment approaches would be to provide immediate and extended protection against CINV.
Twelve healthy people were enrolled in the study. On day 1 of the study, study participants were given the Sancuso patch and IV granisetron. On day 7, the first patch was removed and a second was applied to the opposite arm.
- IV administration of granisetron produced a rapid increase in plasma levels of granisetron.
- Plasma levels of granisetron from Sancuso peaked about 48 hours after the patch was applied.
- This approach to administering antiemetic medications appeared to be well tolerated. The most common adverse effects were gastrointestinal problems (such as constipation), and administration site conditions.
These results suggest that it’s feasible to use Sancuso in combination with IV granisetron, and to administer a second Sancuso patch after the first. Ongoing research in this area may contribute to improved management of chemotherapy-induced nausea and vomiting.
Reference: Howell J, O’Mahony B, Gutierrez-Esteinou R. Co-administration of transdermal granisetron and intravenous (IV) granisetron in healthy subjects: a Phase I pharmacokinetic, tolerability and safety study. Presented at the Fifth Annual Chicago Supportive Oncology Conference, October 1–3 2009.