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Chemotherapy-induced nausea and vomiting (CINV) are commonly cited bypatients undergoing chemotherapy as highly feared side effects. In additionto its social and emotional effects, if left untreated, CINV can lead todehydration, malnutrition, treatment delay, or even discontinuation oftreatment.
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"We've made significant progress in our understanding of chemotherapy andhow to prevent its side effects, yet undergoing chemotherapy remains achallenging experience on many levels," said Barbara Rogers, CRNP, MN, AOCN,Adult Hematology-Oncology Nurse Practitioner, Fox Chase Cancer Center. "Weshould have zero tolerance for CINV. A patch that can be applied beforetreatment, releasing medication consistently into the bloodstream over anumber of days, has the potential to impact patient comfort and quality oflife."
Despite advances in treatment, CINV remains a significant issue. Somepatients expect to endure unpleasant symptoms in order to continuechemotherapy and may suffer at home while not under the supervision of ahealth-care professional. With one application of Sancuso, patients receiveup to five consecutive days of CINV treatment.
"When my doctor told me I would need chemotherapy, my first reaction wasto wonder how the treatment would affect my life," said Melvin Hren, aparticipant in the Sancuso clinical trial, whose tumour originated from histhymus gland. "But the patch helped alleviate my fears of some ofchemotherapy's side effects. It didn't interfere with my daily activities,and I was able to complete my cancer treatment without feeling nauseous andsick."
Clinical Result: Continuous and Reliable CINV Control
Sancuso is a transdermal system, or skin patch, that delivers granisetron,its active component and an established inhibitor of nausea and vomiting,through a thin layer of adhesive that attaches the patch to the skin. Themedicine is then released slowly and continuously into the bloodstream for upto five consecutive days.
The F.D.A. approved Sancuso for the prevention of CINV based on theresults of a multicenter Phase III randomized, double-blind, double-dummycontrolled study comparing the efficacy, tolerability and safety of Sancusowith once-daily oral granisetron (2 mg). The trial enrolled 641 patients whoreceived moderately or highly nausea-inducing multi-day chemotherapy, and metits primary endpoint of achieving complete control of CINV, working as well asoral granisetron. Complete control was defined as no vomiting and/orretching, no more than mild nausea and no rescue medication from firstadministration of Sancuso until 24 hours after the last day of chemotherapy.
Sancuso was generally well-tolerated by patients in clinical trials.Adverse reactions considered drug-related by investigators occurred in 8.7percent of patients receiving Sancuso. The most common drug-related adversereaction was constipation. Application site reactions were reported but weremild and did not lead to discontinuation of use. The incidence of skinreactions was comparable to placebo.
Product Approval Introduces ProStrakan Inc.
F.D.A. approval of Sancuso marks the official introduction of ProStrakanInc. in the U.S. The company is also working with regulatory authorities tobring Sancuso to market in Europe. An international pharmaceuticalorganization, ProStrakan has introduced a range of products in a number of EUterritories.
"ProStrakan was founded on a commitment to developing innovative productsto better meet the needs of
