New Indication Approved for Bunavail
April 27, 2017 – The U.S. FDA has approved a new indication for Bunavail® (buprenorphine/naloxone) for initial treatment of patients beginning therapy for opioid addiction. A product of BioDelivery Sciences International, Bunavail was originally approved in 2014 for the maintenance phase of opioid addiction treatment. Patients should use Bunavail once daily in comprehensive treatment plans that include counseling and psychosocial support.
Per the requirements of the Drug Addiction Treatment Act (DATA), the prescribing of Bunavail is restricted to physicians who are specially trained and registered with the U.S. Department of Health and Human Services. Patients prescribed Bunavail must be given a medication guide that details its correct use, and must be made aware of the many possible side effects. Bunavail is available in three strengths, with a recommended daily maintenance dose of 8.4mg buprenorphine/1.4mg naloxone. Thanks to BioDelivery’s proprietary BioErodible MucoAdhesive (BEMA®) technology, Bunavail adheres to the inside of the cheek and dissolves to release the required dose.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.