Profile: BioDelivery Sciences International Inc (BDSI.OQ)
18 Jun 2019
BioDelivery Sciences International, Inc., incorporated on April 18, 2002, is a specialty pharmaceutical company. The Company develops and commercializes, either on its own or in partnerships with third parties, applications of approved therapeutics to address unmet medical needs using drug delivery technologies. The Company develops pharmaceutical products aimed principally in the areas of pain management and addiction. The Company's products utilize the BioErodible MucoAdhesive (BEMA) drug delivery technology, a small, erodible polymer film for application to the buccal mucosa (the lining inside the cheek). The Company's United Sates Food and Drug Administration (FDA) approved product, ONSOLIS (fentanyl buccal soluble film), as well as its approved products BUNAVAIL (buprenorphine and naloxone buccal film) buccal film and BELBUCA (buprenorphine) buccal film, utilize BEMA technology.
BUNAVAIL (buprenorphine and naloxone) buccal film
BUNAVAIL is indicated for the maintenance treatment of opioid dependence. The product combines a high dose of buprenorphine along with an abuse deterrent agent, naloxone.
BELBUCA (BEMA Buprenorphine) for Chronic Pain
BELBUCA is a partial mu-opioid agonist and a treatment for the management of pain severe enough to require daily, around the clock, long-term opioid treatment for which alternative treatment options are inadequate. The product is licensed on an around the world basis to Endo Pharmaceuticals, Inc. (Endo).
ONSOLIS (fentanyl buccal soluble film)
ONSOLIS is approved in the United States, Canada, European Union (EU) (where it is marketed as BREAKYL) and Taiwan (where it is marketed as PAINKYL), for the management of breakthrough pain in opioid tolerant adult patients with cancer. The commercial rights to ONSOLIS are licensed to Meda AB for all territories around the world except for Taiwan (licensed to TTY Biopharm Co., Ltd.).
Clonidine Topical Gel
Clonidine Topical Gel is a non- BEMA product. The product is in Phase III development for the treatment of painful diabetic neuropathy (PDN).
Buprenorphine Depot Injection
Buprenorphine Depot Injection is in development as an injectable, extended release, microparticle formulation of buprenorphine for the treatment of opioid dependence and chronic pain. The product candidate is in the pre-clinical stage of development.
The Company competes with Purdue Pharmaceuticals, Pfizer, Pernix Therapeutics, DepoMed, Teva Pharmaceutical Industries Ltd., Sentynl Therapeutics and Actavis Laboratories UT, Inc.
BioDelivery Sciences International Inc
4131 Parklake Ave Ste 225
RALEIGH NC 27612-2390