Raleigh-based BioDelivery Sciences plans to expand its clinical development program to seek more pain indications for its lead product, BEMA Fentanyl.
BioDelivery and its Swedish commercial partner, Meda AB, plan to assess the efficacy and safety of the product for the treatment of breakthrough pain associated with other chronic pain conditions beyond cancer, such as low back pain, arthritis, and neuropathic pain.
BioDelivery filed its initial BEMA Fentanyl New Drug Application with the U.S. Food and Drug Administration last Oct. 31 for the treatment of breakthrough pain in opioid-tolerant patients with cancer. The firm expects a decision from the FDA in August.
If BEMA Fentanyl is approved by the FDA, BioDelivery is to receive milestone payments from Meda totaling $30 million, and could begin receiving royalty revenues from the product as early as the fourth quarter of 2008.
The market for breakthrough cancer pain treatment is expected to exceed $1.5 billion over the next several years.
BioDelivery entered a licensing agreement with Meda in August 2006 for the drug's distribution rights in Europe, and another last September covering distribution in the U.S., Canada and Mexico. Plans for submitting a regulatory application in Europe are underway.