BEMA Fentanyl, developed by BioDelivery Sciences Inc (BDSI), is being tested as a treatment for breakthrough pain in cancer patients and could expand the use of the widely-used drug as it works in a higher proportion of patients than rival product Fentora from Cephalon.
In the 80-patient study, BDSI's formulation was significantly more effective than placebo at quashing breakthrough pain after 30 minutes, with only 3 per cent of recipients failing to control their pain with the product.
In contrast, Fentora - which delivers according to published data delivers a lower peak plasma concentration than BEMA Fentanyl at equivalent doses - fails to control symptoms in around a third of patients, and is also associated with a higher rate of side effects such as local irritation and ulceration, according to Andrew Finn, BDSI's executive vice president of product development.
BDSI will seek approval for doses of BEMA Fentanyl up to 1200mcg, while Fentora is only available at doses of up to 800mcg at present.
Fentora was launched last September and is already shaping up as a healthy earner for Cephalon.
In 2006 it brought in a little under $30m, while Cephalon's older transmucosal fentanyl product Actiq - now facing generic competition - contributed $572m to the company's coffers.
But despite being the market leader in the transmucosal segment Actiq is still only used to treat around 10 per cent of the eligible patients in the US, with most still receiving treatment for breakthrough pain via conventional oral formulations of the analgesic.
"We believe that the efficacy and safety profile of BEMA Fentanyl is well suited to penetrate the 90 per cent of the market that is not served by existing products," commented Dr Mark Sirgo, president and CEO of BDSI.
He is predicting that the product will achieve peak sales of $250m. Critically, the 30-minute endpoint in the trial is the one the Food and Drug Administration will be looking at most closely when it reviews the New Drug Application for BEMA Fentanyl later this year.
So, assuming upcoming safety data due in a few months don't reveal any unpleasant surprises, prospects for the product look good.
Investors clearly agreed, with brisk trading adding 55 per cent to BDSI's share price, running at $7.21 as this article went to press.
Technology platform endorsed And while this is good news for BDSI in the near-term it also provides a great endorsement of the value of the BEMA (Bioerodible MucoAdhesive Disc) drug delivery technology underpinning the product.
The bilayer patch binds to the inside of the cheek and delivers its payload directly across the mucosa lining, typically eroding away within 20-30 minutes.
A backing layer prevents active drug being deposited in saliva and swallowed, helping to control the administration.
And compared to orodispersible fentanyl tablets it is hard to extract the fentanyl from the patch, providing a safeguard against opioid abuse.
BioDelivery has two other BEMA-based products in early stage clinical testing: a BEMA long-acting analgesic for moderate to severe pain, and BEMA Zolpidem for insomnia.
It is also developing an amphotericin B product for fungal infections based on its Bioral delivery technology.
The company predicts the three drugs could total $1.15 billion in peak sales.
BioDelivery is also developing a non-BEMA-based buccal product, Emezine (prochlorperazine), as a nausea treatment.