BioDelivery Sciences International (NSDQ:BDSI) said today that the FDA approved a supplemental new drug application for its Bunavail buprenorphine and naloxone buccal film. The revised indication allows patients to use the product to initiate buprenorphine treatment for opioid dependence.
Induction is the initial process by which a patient transitions from abusing an opioid to buprenorphine treatment which is designed to relieve cravings and withdrawal, according to BioDelivery Sciences.
The FDA approved Bunavail’s initial new drug application in June 2014, which covered the film for use during the maintenance treatment phase of opioid dependence therapy.
The Raleigh, N.C.-based company said the expanded indication will likely help maintain competitiveness in the market.
BioDelivery Sciences touts Bunavail as the 1st and only buprenorphine and naloxone formulation for administration inside of the cheek. The buccal film has twice the bioavailability of buprenorphine compared to the market leader, Suboxone, according to the company. BioDelivery Sciences said that Bunavail’s increased bioavailability means that plasma concentrations of buprenorphine comparable to Suboxone can be achieved with half the dose, reducing the potential for misuse.
BDSI shares were trading at $1.83 apiece in mid-morning activity today, up 4.3%