Northern Ireland-based Galen licensed rights to Penthrox, an inhalation delivered, self-administered formulation of the pain drug methoxyflurane, this week for A$650,000 (US$587,000).
Penthrox has been available in Australia since the 1970s, where it has been used by the military, sports teams to treat traumatic injury and by patients in hospitals, emergency rooms and ambulances.
The product is not approved in Europe. However, MVP submitted it to the UK Medicines and Healthcare products Regulatory Agency (MHRA) last October and a final decision is expected before the end of the year.
A Galen spokesperson told in-Pharmatechnologist.com that: “With regards to the choice of Penthrox, our view was that the product profile of a fast-acting analgesic, in a portable delivery device, without the potential opioid side-effects, fits a market need in the UK and Ireland.
“In addition, the positive feedback from the clinical trial sites in the UK, along with the historical success of Penthrox in Australia, points to an excellent opportunity for Galen in building its specialty pharma business.”
The Phase III study examined the drug for the treatment of acute pain in patients arriving at A&E departments with minor trauma.
The trial enrolled 300 patients and was conducted at six major hospitals including Queens Medical Centre in Nottingham; Newcastle’s Royal Victoria Infirmary, as well as Birmingham Children’s Hospital and Middleborough’s James Cook University Hospital.
The technology used to administer Penthrox is a disposable, single-use inhaler that allows patients to self-medicate under supervision in response to pain.
Galen declined to provide any more details of the agreement with MVP, but did confirm that the agreement does not give it any rights to use the Penthrox delivery technology in conjunction with any of the other products it sells.