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Inhaler Approved in Canada for Acute Pain

For trauma or interventional procedures, low-dose methoxyflurane may offer short-term relief

In the Pipeline – A PPM Brief

Health Canada recently granted marketing authorization to low-dose methoxyflurane, an inhaled analgesic non-opioid, for the short-term relief of moderate to severe acute pain associated with trauma or interventional medical procedures in adult patients.1 Branded as Penthrox, from Purdue Pharma (Canada) and Medical Developments International Limited (MDI, Australia), the treatment can be self-administered by the patient under the supervision of trained healthcare practitioners.

“A non-invasive, fast-acting, treatment option that does not require opioid-associated monitoring, like Penthrox, is necessary,” said Tom Koutsavlis, MD, vice president of research and development and medical affairs at Purdue Pharma (Canada). “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.”

Under the partnership, Purdue Pharma has the exclusive right to register, market, promote, distribute and sell Penthrox in Canada. MDI will retain clinical development activities, manufacturing, and supplying of Penthrox to Purdue Pharma.1

“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,” said John Sharman, chief executive officer at MDI.

FDA Approval

As of August 2017, MDI has been on track to obtain US FDA approval of Penthrox –which is expected by 2020. The company plans to submit an Investigational New Drug application to the agency for “fast track” status. Additional Phase 3 trial study and data support is forthcoming.

Last updated on: April 23, 2018
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Post-trauma Pain Management: A “Back to Basics” Approach
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