PENTHROX® Receives Marketing Authorization from Health Canada for Adult Patients Requiring Relief from Moderate to Severe Acute Pain Associated with Trauma or Interventional Medical Procedures Français
PICKERING, ON, April 10, 2018 /CNW/ - Purdue Pharma (Canada) and Medical Developments International Limited (MDI), announce today that PENTHROX®, a low dose methoxyflurane, has been granted marketing authorization by Health Canada for the short-term relief of moderate to severe acute pain, associated with trauma or interventional medical procedures, in conscious adult patients1.
PENTHROX® (methoxyflurane) is an effective, fast-acting, inhaled analgesic product which is not classified as an opioid. The treatment is self-administered by the patient under the supervision of a trained healthcare practitioner, including nurses and paramedics.
Dr. Tom Koutsavlis, Vice President, Research & Development and Medical Affairs, Purdue Pharma (Canada), commented: "From my experience, a non-invasive, fast-acting, treatment option that does not require opioid-associated monitoring, like PENTHROX®, is necessary. PENTHROX® has the added benefit of being a lightweight, portable, handheld inhaler which is also patient-controlled. Not only has it been shown to be safe and effective, it can also help simplify trauma treatments for both patients and their caregivers."
John Sharman, Chief Executive Officer, Medical Developments International Ltd: "With 30 years of extensive global use behind it, PENTHROX® has been a key treatment in the short-term relief of trauma pain with more than six million administrations worldwide2. PENTHROX® is fast becoming the first-choice pain treatment for trauma and interventional medical procedures in several countries where it has been approved for registration. We're proud to have a partner, like Purdue, with a long and successful legacy in treating pain now making PENTHROX® available to Canadian patients in both trauma and interventional medical procedures."
Under the terms of the exclusive agreement between the companies, Purdue Pharma (Canada) has the exclusive right to register, market, promote, distribute and sell PENTHROX® in Canada. MDI will retain clinical development activities, as well as the manufacture and supply of PENTHROX® to Purdue Pharma (Canada).
David Pidduck, President and CEO, Purdue Pharma (Canada), commented: "As a leader in pain management, we remain steadfast in our commitment to improving the lives of Canadian patients suffering from pain. We're excited to add PENTHROX® to our existing product portfolio and will continue on our promise to directly support the pain treatment landscape across this country."
About PENTHROX®
PENTHROX® (methoxyflurane) is the only small, lightweight, handheld, fast-acting, inhaled analgesic that is self-administered under the supervision of the treating healthcare practitioner indicated for the short-term relief of moderate to severe pain, associated with trauma or interventional medical procedures, in conscious adults. PENTHROX® provides rapid, effective pain relief in five minutes, with no need for needles and is not classified as an opioid. PENTHROX® allows patients to control their own pain relief by moderating the amount of PENTHROX® inhaled1.
Adverse events with PENTHROX® are mild and temporary. The most common adverse events reported with PENTHROX® in clinical trials were dizziness, somnolence and headache1.
PENTHROX® is approved for marketing in more than 20 countries, including Australia, UK, Ireland, France, Belgium, Sweden, Singapore and South Africa.
Please consult the Product Monograph posted at www.purdue.ca 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 Consumer Healthcare 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
About Medical Developments International Ltd
MDI is an Australian company delivering emergency medical solutions dedicated to improving patient outcomes. MDI is a leader in emergency pain relief and respiratory products. The Company manufactures PENTHROX®, a fast-acting trauma & pain relief product. It is used in Australian Hospitals including Emergency Departments, Australian Ambulance Services, the Australian Defense Forces, sports medicine and for analgesia during short surgical procedures such as Dental and Cosmetic surgery as well as in other medical applications. MDI is expanding internationally and manufactures a range of world-leading Asthma respiratory devices.
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| 1 |
Purdue Pharma (Canada), PENTHROX™ (methoxyflurane) Product Monograph, April 6, 2018. |
| 2 |
Medical Developments International (MDI). Periodic Safety Update Report number 005 for Methoxyflurane (Penthrox®), Nov .2017 |
SOURCE Purdue Pharma
Media Inquiries: Sarah L. Robertson, Director of Communications, Purdue Pharma (Canada), Pickering, ON, Canada, [email protected]; John Sharman, Chief Executive Officer, Medical Developments International Ltd., +61 95471888; David Williams, Chairman, +61 (0) 414 383 593
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