PICKERING, ON, Nov. 28, 2017 /CNW/ - Purdue Pharma (Canada) announce today that AKYNZEO™ (netupitant/palonosetron hydrochloride) capsules are now available to Canadian cancer patients for the prevention of chemotherapy-induced nausea and vomiting (CINV).
AKYNZEO™ (netupitant/palonosetron hydrochloride) capsules received Notice of Compliance (NOC) from Health Canada on September 28, 2017 and is the first approved fixed dose combination oral agent that targets two critical signalling pathways associated with CINV by combining netupitant, an NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, in a single capsule for the prevention of CINV i.
The effects of chemotherapy can vary from patient to patient and CINV is often a common side effect that can occur during a patient's chemotherapy treatment. If left uncontrolled, CINV may lead to dehydration, electrolyte imbalances, loss of appetite, fatigue and a reduced quality of life ii.
David Pidduck, President and CEO, Purdue Pharma (Canada), commented: "Cancer, an upsetting and often overwhelming diagnosis for patients and their families, requires safe and effective therapies that not only attempt to save patient lives, but also increase their quality of life. We are proud to bring AKYNZEO™ to market in Canada. We believe it is an important and novel treatment in cancer supportive care that will offer physicians and their patients a new option to help mitigate the distressing effects of chemotherapy-induced nausea and vomiting."
Purdue Pharma (Canada) has been granted from Helsinn Healthcare S.A. (hereafter "Helsinn"), a Swiss Group focused on building quality cancer care, the exclusive right to register, market, promote, distribute and sell AKYNZEO™ in Canada. Helsinn will retain clinical development activities, as well as the manufacture and supply of AKYNZEO™ to Purdue Pharma (Canada).
AKYNZEO™ (netupitant/palonosetron hydrochloride), in combination with dexamethasone, is indicated for once per-cycle treatment in adult patients for the prevention of acute delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy as well as for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone. It is the first approved fixed dose oral combination agent that targets two critical signaling pathways associated with CINV by combining netupitant, an NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, in a single capsule for the prevention of CINV. The most common adverse events reported with AKYNZEO™ in clinical trials were headache (3.6%), constipation (3.0%) and fatigue (1.2%)i.
AKYNZEO™ has been recommended under the antiemetic guidelines of the National Comprehensive Cancer Network (NCCN), an alliance of the world's leading cancer centers, both in Highly Emetogenic Chemotherapy (HEC) and Moderately Emetogenic Chemotherapy (MEC). It is also recommended in the Clinical Practice Guidelines from the American Society for Clinical Oncology (ASCO) as one of the therapeutic options to facilitate the application of antiemetic standard of care for patients receiving HEC regimens by preventing nausea and vomiting in both the acute and delayed phases following chemotherapy treatment.
Purdue Pharma (Canada) will be the sole distributor for AKYNZEO™ in Canada under terms of the current commercialization contract with Helsinn Group. AKYNZEO™ is already approved in 47 countries including the US, EU, Switzerland and Australia.
Please consult the Product Monograph posted at http://purdue.ca/wp-content/uploads/2017/10/Akynzeo-PM-EN.pdf?x50798 for complete administration and safety information.
About Purdue Pharma (Canada)
Purdue Pharma (Canada) is a research-based pharmaceutical and consumer healthcare company which has operated in Canada for over 60 years. Its 400 employees are committed to improving the health and quality of life of Canadians. The company has a broad portfolio of prescription and non-prescription medications including: prescription treatments for pain, ADHD, chemotherapy-induced nausea and vomiting (CINV), various ophthalmic conditions and OTC products. The company supports evidence-based education for the safe use of its products. Its headquarters, located in Pickering, Ontario, include integrated research and development, formulation and manufacturing operations. Privately held and founded by physicians, Purdue Pharma (Canada) is independently associated with the worldwide Purdue/Napp/Mundipharma network of companies. Learn more at www.purdue.ca
i Purdue Pharma (Canada), AKYNZEO™ (netupitant/palonosetron hydrochloride capsules) capsules Product Monograph, September 28, 2017
SOURCE Purdue Pharma
For further information: Media Inquiries: Sarah L. Robertson, Director of Communications, Purdue Pharma (Canada), Pickering, ON, Canada, [email protected]