This expanded program is funded by and coordinated with Meda, BDSI’s US and European commercial partner for Bema Fentanyl. Under this new program, BDSI and Meda plan to conduct additional clinical studies to support the expanded use of Bema Fentanyl in other common chronic pain conditions where breakthrough pain is prevalent, such as low back pain, arthritis, and neuropathic pain.
BDSI believes that expanding potential indications for Bema Fentanyl beyond the initial indication of breakthrough cancer pain will help BDSI and Meda maximize the potential value of the product, assuming positive trial data and ultimate FDA approval. Sales, marketing, and clinical studies to support expanded indications will be funded by Meda under its agreements with BDSI. Meda and BDSI will collaborate on executing the clinical development program.
Mark Sirgo, president and CEO of BDSI, said: “While our top priority for 2008 remains the FDA approval and successful launch of Bema Fentanyl for cancer breakthrough pain, we believe there remains a significant unmet medical need for effective and well tolerated treatments for those suffering from breakthrough pain related to other conditions such as back pain and arthritis.”