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BioDelivery Sciences, Endo Pharmaceuticals announce FDA approval of buccal film

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BioDelivery Sciences International Inc. and its partner Endo Pharmaceuticals Inc. recently announced the FDA has approved BELBUCA buccal film for use in patients with severe chronic pain that cannot be managed with alternative treatment options.

Due to a 2012 worldwide license and development agreement between BioDelivery Sciences International Inc. (BDSI) and Endo Pharmaceuticals Inc., a payment of $50 million to BDSI from Endo will be made. According to a BDSI press release, additional payments to the company from Endo Pharmaceuticals Inc. may be made in 2016 if certain sales milestones are met. BDSI may also receive tiered royalties on net sales of BELBUCA. According to the press release, the $50 million payment — combined with current cash in hand — may permit BDSI to operate its business to approximately the middle of 2017.

The BELBUCA buccal film is indicated for use in patients with chronic pain severe enough to require daily, long-term management with opioids.

Reference:

www.bdsi.com.