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Create painless devices for quicker regulatory approval, says BD

By Natalie Morrison , 28-Feb-2012

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Reduced-pain injection systems are the key to gaining regulatory approval for new products, according to BD.

Speaking exclusively to in-PharmaTechnologist at Pharmapack Europe 2012, the firm presented its new clinical trial results over its recently launched Physioject auto-injector.

The results showed participants injecting themselves with the device scored an average of six on a pain scale ranging from one to 100, as opposed to 15 with a normal syringe.

Joel Cotten, European product manager of pharmaceutical systems, said that using the Physioject, and devices like it that focus on reducing pain, is crucial for gaining regulatory approval.

He said it falls in line with the FDA’s (US Food and Drug Administration) recent focus on patient compliance.

“A big driving factor in drug delivery is patient compliance, and I think the FDA understand that because they are putting a lot more focus on what they call human factor engineering.

“Basically they are taking the point of view of the patient to make more acceptable devices.”

Results

Although the recent study on the Physioject showed a reduction of pain when self-injecting, researchers are still theorising exactly why that is.

When asked why it causes less pain, Cotton said the team believe it is due to a variety of psychological factors, including the non-medical appearance of the device and the lack of a visible needle. More studies will be carried out into to the device.

However he did say the product is more likely to gain regulatory approval more quickly. He said: “It is exactly the same type of volume injected, depth of injection as prefilled syringe. It is the same, but more friendly.

“Obviously we have more tests to make when we partner with a company over drug and device, but the work is facilitated, because when you go to the authorities and show that your system creates less pain and gives the same service it passes more easily.”

BD has also recently launched several other products with a view to reducing pain, including a 4mm length mini needle with a 32 gauge – the smallest needle compatible with an insulin pen on the market.

It also released a micro needle, 1.5mm in length, with Sanofi for flu vaccination.

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