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Name

Single use Osprey Device - short-action opioid spray delivery and formulation for cancer incident and breakthrough pain

Organization name

Alexander Yule Consulting

Profile

Osprey is an established and successful UK medical device. The Osprey Device is a single-use, tamper-proof, drug delivery system of all plastic construction which delivers a fixed dose of sufentanil as a uniform spray to the buccal cavity from where it is rapidly absorbed into the bloodstream. The device is prepared for use by a single twist of the cap, held to the open mouth and the drug delivered by a single press. The device locks on use, cannot be reused and there is no residual drug content to complicate disposal.

The Osprey Device has been evaluated in a single proof of concept clinical study conducted in the UK. Single dose pharmacokinetics and absolute bioavailability of sufentanil sublingual spray (25µg) were compared with that of a single intravenously administered dose of sufentanil (12.5µg) in an open label, randomised two-way crossover study conducted in six healthy male volunteers. Sufentanil sublingual spray was well tolerated with no drug-related adverse events. Sublingual sufentanil bioavailability was 61% with a low coefficient of variability and a Tmax of 0.68 hours. The pharmacokinetic data implied an onset of analgesia within 10-15 minutes of administration with duration of one hour or more. The Osprey Device is manufactured under an established GMP process. Product stability has been established as being at least 24 months.

Osprey wishes to engage with an experienced pharmaceutical development and marketing partner capable of undertaking further clinical development and eventual regulatory submission of the Osprey Device. Either a license or divestment arrangement would be considered. Osprey is willing to assist in transfer of the manufacturing process or to undertake device manufacture on a contract basis.

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