The U. S. Food and Drug Administration (FDA) has given green signal to BioDelivery Sciences International (BDSI) for a new drug application for BunavailT buccal film.

Bunavail is used for maintenance treatment of opioid dependence. It comprises of a film that sticks to the inside of the cheek. It uses an advanced drug delivery technology that allows patients to talk, swallow and carry on with daily activities while the medication is absorbed slowly.

Such a thing is not possible with other sublingual products as they are required to be kept under the tongue until it gets dissolved. Due to its advanced technology, Bunavail's bioavailability rate of buprenorphine is double than the industry standard, Suboxone, a sublingual medication.

"In this study, Bunavail demonstrated favorable safety and efficacy in the maintenance treatment of opioid dependence", affirmed Gregory Sullivan, lead investigator of the Phase Three Bunavail Safety Study.

When asked from study participants, they found Bunavail easy to use and not bad in taste. In fact, many people who used to face constipation while on Suboxone said the condition has imporved with Bunavail.

Sullivan said they are hoping with the improved drug absorption, Bunavail may solve some of the challenges being linked with sublingual administration.

BDSI said Bunavail is expected to get launched late in the third quarter of 2014. Using BDSI's advanced drug delivery technology, BioErodible MucoAdhesive (BEMA), Bunavail has been designed.

With the help of the advanced drug delivery technology, buprenorphine gets absorbed in the body in an efficient and convenient manner. Due to this, chances of its misuse and side-effects also get reduced. Sullivan said it is the novel treatment approach for more than two million people in the US.