FDA decision on BioDelivery's Bunavail expected June 2014
This article was originally published in Scrip
The US FDA has accepted for review BioDelivery Sciences International's new drug application for Bunavail (buprenorphine naloxone buccal film) as a maintenance therapy for opioid dependence, the company revealed on 9 October.
The agency is expected to make a decision by early June 2014,
Shares of BDSI rose 4.65% in morning trading on 9 October, only to later to take a tumble, settling at $4.97, a loss of 19 cents, or 3.7%.
If approved, Bunavail will compete against Reckitt Benckiser's sublingual film Suboxone (buprenorphine/naloxone), which has dominated the market – generating more than a $1 billion in sales last year – and Orexo's newly approved sublingual tablet Zubsolv (buprenorphine/naloxone), which gained the FDA's blessing in July (scripintelligence.com, 10 September 2012, 4 July 2013).
Bunavail's NDA was submitted under the FDA's 505(b)(2) regulatory pathway, which permits US regulators to rely on other applications’ data to conduct the agency’s review (scripintelligence.com, 2 August 2013).
The experimental medicine uses BDSI's patented BioErodible MucoAdhesive (BEMA) technology, which delivers buprenorphine, which the company said is poorly absorbed orally from the gastrointestinal tract, across the buccal mucosa, or inside lining of the cheek.
Buprenorphine has been shown to reduce the craving and withdrawal effects of opioid dependence.
Bunavail is formulated with naloxone, which is an abuse-deterrent agent.
Opioid dependence is a significantly undertreated condition in the US, with nearly two million people dependent on prescription opioids, according to the 2010 National Survey on Drug Use and Health.
The clinical program for Bunavail includes a bioequivalence study to Suboxone tablets, as agreed on with the FDA, and a study assessing the safety and tolerability of BDSI's drug in opioid dependent patients switched from Reckitt Benckiser's sublingual film or tablets to BDSI's buccal film.
The clinical study of 249 opioid-dependent patients, the majority of those switched from Suboxone tablets or films found Bunavail to be easy to use and pleasant tasting, according to BDSI.