FDA Approves New Opioid Dependence Drug

BioDelivery Sciences International, Inc. (BDSI) has received approval from the FDA for its new drug BUNAVAIL™ (buprenorphine and naloxone) buccal film (CIII), which represents a new efficient approach to drugs aimed at the treatment of opioid dependence. The drug, which is expected to be available late in the third quarter of 2014, uses a delivery method known as buccal administration, in which the drug sticks inside the cheek while it is being absorbed. According to BDSI, this new delivery method is a vast improvement over traditional sublingual (under the tongue) delivery methods because it allows a patient to continue his or her daily activities while the drug is being absorbed.


Opioid dependence is a pervasive problem that is difficult to correct. Dependence, addiction, and overdose are among the risks that accompany opioids, which, when used appropriately, can be very effective in reducing pain (see The risk of opioid abuse, addiction, and overdose in treatment of chronic pain). The approval of BUNAVAIL comes as somewhat of a bright light in a time of controversy surrounding the use and approval of opioids. Notably, the FDA’s 2013 approval of Zohydro™, a hydrocodone drug containing ten times the dose found in previously existing hydrocodone-based drugs, caused a spark which led to significant attention and criticism for Zohydro and opioids more broadly (see Should States Limit Access to FDA-Approved Opioids?). Between the growing awareness surrounding the dangers of opioid abuse and the condemnation of opioids generally, a new efficient and effective treatment option for opioid dependence represents a significant step when combatting a condition that, according to BDSI, too often goes untreated.


The market for opioid dependence drugs is booming. In 2013, sales of Suboxone® sublingual film reached $1.3 billion in the U.S. alone. BDSA is anticipating the peak sales potential for BUNAVAIL to rise as high as $250 million in 2014. The marketing and sales of BUNAVAIL is going to be undertaken directly by BDSI and it will be the first time that BDSI has done so with one of its drugs.