FDA Approves BioDelivery Sciences’, Endo Pharmaceuticals’ Belbuca

The FDA has approved BioDelivery Sciences’ and Endo Pharmaceuticals’ Belbuca to treat chronic pain.

Indicated for constant care, rather than as-needed, the opioid provides a new option for patients dealing with severe chronic pain.

The drug’s approval will bring BDSI $50 million from partner Endo, included in the development deal struck in 2012. BDSI may also be eligible for future sales milestone payments and tiered royalties.

FDA’s approval covers seven dosage strengths, BDSI says. It will go to market in early 2016.

Belbuca (buprenorphine HCI) will carry a black box warning on potentially fatal abuse and addiction — reminding prescribers to evaluate risk and monitor for misuse, even as the company touts Belbuca’s classification as a Schedule 3 drug.