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BioDelivery's Bunavail Supply Hit by Specification Issues

BioDelivery Sciences International, Inc.BDSI announced that supply of its opioid-dependence drug, Bunavail, will be constrained in the near term due to a delay in releasing four new batches of the product to wholesalers. The delay is due to the introduction of a new source of a standard polymer by the supplier to BioDelivery's contract manufacturer of Bunavail that led to a product specification change requiring FDA approval.

BioDelivery has submitted the documentation to the FDA requesting the specification change as well as the release of the existing product to wholesalers. A response from the FDA is expected earliest by the next few days but not later than next week. A positive decision would allow the company to release Bunavail's batches to wholesalers which would be sufficient to meet the product's current and projected market demand.

BioDelivery further clarified that the company's contract manufacturer has a polymer unrelated to this source change so the specification change is valid only to product batches awaiting shipment to wholesalers and not to the product currently being manufactured. BioDelivery expects the product under production to hit the market next month, irrespective of the outcome.

Currently, the company is working with wholesalers, pharmacies and healthcare practitioners to make sure that existing supplies of Bunavail are available in locations with greater demand.

Meanwhile, BioDelivery confirmed that the issue related to product specification change will not affect the company's other products including its chronic pain drug, Belbuca. The drug is currently under FDA review with a response expected on Oct 23.

Considering that Bunavail is the company's sole marketed product, supply constraint related to the product and any negative outcome on the regulatory front will have an impact on the product's sales. We expect investor focus to remain on updates from the company and on the approval status of Belbuca.

BioDelivery is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector are Amgen Inc. AMGN , AstraZeneca plc AZN and Endo International plc ENDP . All three carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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