Approval includes a revised indication for initiation treatment.
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for buprenorphine and naloxone (BUNAVAIL/BioDelivery Sciences International) buccal film.
The drug’s indication was revised to include the use of the drug for the initiation of buprenorphine treatment for opioid dependence. Previously, the indication for buprenorphine and naloxone only covered the maintenance treatment phase of opioid dependence treatment.
The most recent approval includes induction, or “the initial process undertaken when a patient is transitioned from the abused opioid responsible for their addiction to the dose of buprenorphine and naloxone which is intended to provide relief from cravings and withdrawal,” according to a BioDelivery Sciences release. Induction is the first step to assist a patient in discontinuing or markedly reducing their use of other opioids.
The expansion of the indication for buprenorphine and naloxone is expected to maintain its competitiveness in the market, according to BioDelivery Sciences, and allows the company’s sales team to communicate its benefits 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,” according to the release.
Buprenorphine is an opioid that can cause physical dependence. Patients may become sick with uncomfortable withdrawal symptoms because the body has become used to the medicine.
Buprenorphine and naloxone can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous route in combination with benzodiazepines, sedatives, tranquilizers or alcohol.
Common side effects include headache, drug withdrawal syndrome, lethargy, sweating, constipation, insomnia, fatigue and sleepiness.
Read the full release here: http://www.prnewswire.com/news-releases/biodelivery-sciences-announces-the-approval-of-bunavail-for-induction-of-buprenorphine-treatment-for-opioid-dependence-300449210.html