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BioDelivery Sciences Announces Short-Term Supply Constraints for BUNAVAIL®

RALEIGH, N.C., Oct. 14, 2015 /PRNewswire/ -- BioDelivery Sciences International, Inc. (BDSI) announced short-term supply constraints for BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) due to a delay in the release to wholesalers of four recently manufactured batches of the product. The delay is the result of the recent introduction of a new source of a standard polymer by the supplier to BDSI's contract manufacturer of BUNAVAIL. This new source has led to an unforeseeable product specification change requiring U.S. Food and Drug Administration (FDA) approval, and as such, is preventing the release of these four batches to wholesalers. BDSI is interacting with FDA on a daily basis and has submitted to FDA requested documentation to support the specification change needed along with a request for approval to release the existing product to wholesalers. FDA has told BDSI that their decision regarding the requested specification change can be expected within days and no later than next week. A positive decision will allow release of these batches of BUNAVAIL to wholesalers.

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Since BDSI's contract manufacturer also has polymer not related to this source change, this issue applies only to product batches awaiting shipment to wholesalers and not to product currently in production. The issue has no impact on any other BDSI product, including BELBUCA, which has a PDUFA date of October 23.

The batches awaiting the FDA decision are more than adequate to meet current and anticipated market demand for BUNAVAIL. Assuming a positive FDA decision, any near-term supply outages should be limited. Regardless of the decision by FDA, BDSI anticipates having the product currently being manufactured in the field in November.

BDSI management is working diligently with wholesalers, pharmacies and healthcare practitioners to help ensure that available supplies are allocated to locations with high demand. BDSI will communicate material updates regarding this matter, including the decision by FDA, as information becomes available.

About BUNAVAIL

INDICATION

BUNAVAIL (buprenorphine and naloxone) Buccal Film (CIII) is a prescription medicine indicated for the maintenance treatment of opioid dependence. BUNAVAIL should be used as part of a complete treatment plan to include counseling and psychosocial support.

Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA).

IMPORTANT SAFETY INFORMATION

Keep BUNAVAIL (buprenorphine and naloxone) Buccal Film (CIII) out of the sight and reach of children. Ingestion of BUNAVAIL by a child may cause severe breathing problems and death. If a child takes BUNAVAIL, get emergency help right away.

Do not take BUNAVAIL if you are allergic to buprenorphine or naloxone, as serious negative effects including anaphylactic shock, have been reported.

Do not take BUNAVAIL before the effects of other opioids (e.g., heroin, methadone, oxycodone, morphine) have lessened as you may experience withdrawal...


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