FDA Approves BELBUCA Buccal Film for Chronic Pain

FDA Approves BELBUCA Buccal Film for Chronic Pain
BDSLlogoRaleigh, North Carolina based BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine, and its partner Endo Pharmaceuticals Inc. (Endo), a subsidiary of Endo International plc, announced that the U.S. Food and Drug Administration (FDA) has approved BELBUCA (CIII) (buprenorphine HCl) buccal film for patients with chronic pain that is sufficiently severe to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate. Opioid analgesics can play an important role in both acute and chronic pain management, exerting their effects by binding to opioid receptors. However, while some of these effects, notably analgesia, are desirable, others such as sedation, nausea, cognitive impairment, dry mouth (also leading to potential accelerated tooth decay and gum disease), and constipation, can be problematic. And since chronic pain necessitates use of long term treatment, such adverse events can impact quality of life and impede adherence. Additionally, use of long-term therapy can lead to concerns regarding drug abuse, addiction and dependency, and in some cases even death. BDSI describes Buprenorphine as being a partial mu-opioid receptor agonist and a kappa antagonist, making it unique compared to full m
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