BioDelivery Sciences International (BDSI), a specialty pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for Bunavail (buprenorphine and naloxone) buccal film (CIII) revising the indication to include the use of Bunavail for the initiation of buprenorphine treatment for opioid dependence.
The approval broadens the indication for Bunavail to include induction, or the initial process undertaken when a patient is transitioned from the abused opioid responsible for their addiction to the dose of Bunavail which is intended to provide relief from cravings and withdrawal. Induction is the first step to assist a patient in discontinuing or markedly reducing their use of other opioids. Previously, the indication for Bunavail only covered the maintenance treatment phase of opioid dependence treatment.
The expansion of the indication for Bunavail is expected to help maintain the competitiveness of Bunavail in the market and allows BDSI and its sales representatives to communicate the benefits of Bunavail in treating opioid dependence from induction through the longer maintenance phase of treatment. This has become particularly important as recent Federal law and administrative rule changes have provided the opportunity for more new patients to enter buprenorphine treatment for opioid dependence.