BioDeliverySciences (Nasdaq: BDSI) appears well on its way to delivering a new means of treating opioid dependence.
The Raleigh-based drug delivery technology firm said Wednesday that the U.S. Food and Drug Administration had accepted its New Drug Application for its Bunavail product.
BDSI projects sales of up to $250 million if the opioid dependence treatment wins FDA approval next year. A final review is expected to be completed by “early June,” the company said.
Bunavail utilizes BDSI’s proprietary drug delivery technology called BioErodible MucoAdhesive (BEMA), which enables delivery of powerful drugs such as pain killers needed to treat break-through cancer pain, through the lining of the mouth. Bunavail would be used for administration of buprenorphine, a drug that treats opioid dependence and craving.
BDSI is positioning Bunavail as an alternative to Suboxone, which delivers buprenorphine through a thin-film technology that dissolves in the mouth or lower intestine as well as tablets.
“Buprenorphine is poorly absorbed orally from the gastrointestinal tract; however, it is absorbed within the oral cavity transmucosally (across the cheek or under the tongue),” BDSI explained.
“BDSI believes BUNAVAIL may offer meaningful advantages over existing treatments and could provide an alternative to the over 2 million people estimated in the U.S. to be opioid dependent.”
Some 249 patients were transferred from Suboxone to Bunavail during a study.
The opioid dependence market is estimated to be $1.5 billion a year.
