Sancuso (granisetron)
Company: ProStrakan
Approval Status: Approved September 2008
Treatment for: chemotherapy-induced nausea and vomiting
Areas: Gastroenterology; Oncology; Pharmacology/Toxicology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |
General Information
Sancuso is a transdermal elective 5-hydroxytryptamine3 (5-HT3) receptor antagonist with little or no affinity for other serotonin receptors. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. The 5-HT3 antagonists prevent serotonin from binding to 5-HT3 receptors, thus preventing nausea and vomiting.
Sancuso is specifically indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.
Sancuso is supplied as a patch containing 34.3 mg of granisetron; it releases 3.1 mg of granisetron per 24 hours for up to 7 days. Sancuso is designed for transdermal application. The patch should be applied to the upper outer arm a minimum of 24 hours and maximum of 48 hours prior to chemotherapy. The patch should be removed a minimum of 24 hours following chemotherapy and may be worn for up to 7 days, depending on the duration of the chemotherapy regimen.
Clinical Results
FDA Approval
FDA approval of Sancuso was based on the results of a phase III study. This randomized, parallel group, double-blind, double-dummy study enrolled 641subjects receiving moderately (ME) or highly emetogenic (HE) multi-day chemotherapy, across international sites. The patch was applied 24 to 48 hours before the first dose of chemotherapy, and kept in place for 7 days. Oral granisetron (2 mg) was administered daily for the duration of the chemotherapy regimen, one hour before each dose of chemotherapy. The primary endpoint was the proportion of subjetcs achieving no vomiting/retching, only mild nausea and no rescue medication from the first administration until 24 hours after the start of the last day’s administration of multi-day chemotherapy. Efficacy was established in 60.2% of subjects in the Sancuso arm and 64.8% of subjects receiving oral granisetron (difference -4.89%; 95% confidence interval -12.91% to +3.13%).
Ongoing Study Commitments
- ProStrakan has agreed to a deferred pediatric study under PREA for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy for up to five consecutive days in pediatric patients ages 2 to 17. A study to examine the pharmacokinetics of granisetron transdermal system compared to IV dosing in 48 pediatric patients aged 2 to 17 years.
Protocol Submission: February 28, 2010
Study Start: June 30, 2010
Final Report Submission: February 29, 2012 - ProStrakan has agreed to a deferred pediatric study under PREA for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days in pediatric patients ages 2 to 17. A study of the efficacy and safety of transdermal granisetron compared to intravenous granisetron for the prevention of chemotherapy induced nausea and vomiting in 200 pediatric patients aged 2 to 17 years and over 400 patient treatment periods.
Protocol Submission: February 28, 2010
Study Start: June 30, 2011
Final Report Submission: January 31, 2013 - ProStrakan has agreed to conduct a single-site, randomized, cross-over, thorough QT study that evaluates placebo, active control, bolus infusion granisetron, and transdermal granisetron in healthy volunteers.
Protocol Submission: September 30, 2008
Trial Start: March 31, 2009
Final Report Submission: December 31, 2009 - ProStrakan has agreed to an appropriate in vitro or clinical pharmacokinetic study to determine the impact of heat on
the delivery of granisetron from the transdermal system.
Protocol Submission: by October 2008
Study Start: by December 2008
Final Report Submission: by March 2009 - ProStrakan has agreed to a clinical pharmacokinetic study to assess granisetron exposure in human subjects with differing levels of body fat.
Protocol Submission: by October 2008
Study Start: by February 2009
Final Report Submission: by December 2009 - ProStrakan has agreed to a clinical pharmacokinetic study to assess granisetron exposure in elderly individuals (over 65) that includes an even age distribution across the geriatric population.
Protocol Submission: by October 2008
Study Start: by February 2009
Final Report Submission: by December 2009
Side Effects
Adverse events associated with the use of Sancuso may include, but are not limited to, the following:- abdominal pain
- diarrhea
- hypertension
- hypotension
- dizziness
- insomnia
- headache
Mechanism of Action
Sancuso is a transdermal elective 5-hydroxytryptamine3 (5-HT3) receptor antagonist with little or no affinity for other serotonin receptors. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. The antiemetic effects of the antagonist is postulated to stem from blockade of these 5-HT3 receptors, which are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema.Literature References
Tuca A, Roca R, Sala C, Porta J, Serrano G, González-Barboteo J, Gómez-Batiste X Efficacy of Granisetron in the Antiemetic Control of Nonsurgical Intestinal Obstruction in Advanced Cancer: A Phase II Clinical Trial. Journal of Pain and Symptom Management 2008 Sep 11Buchanan D, Muirhead K Intractable nausea and vomiting successfully related with granisetron 5-hydroxytryptamine type 3 receptor antagonists in Palliative Medicine. Palliative Medicine 2007 Dec;21(8):725-6
Additional Information
For additional information regarding Sancuso or chemotherapy induced nausea and vomiting, please visit the Sancuso web page.The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
