BioDelivery Sciences International, Inc. unveiled plans to expand its BEMA Fentanyl deal with Meda AB, BDSI's US and European commercial partner for BEMA Fentanyl.
BioDelivery Sciences and Meda will assess the efficacy and safety of the product for the treatment of breakthrough pain associated with other chronic pain conditions beyond cancer.
Under this new programme, 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 maximise the potential value of the product, assuming positive trial data and ultimate FDA approval.
On October 31, 2007, BDSI filed its initial New Drug Application (NDA) for BEMA Fentanyl for the treatment of breakthrough pain in opioid tolerant patients with cancer. As previously announced, a decision from the FDA on this NDA is expected in August 2008.
Breakthrough pain, or the episodes of severe pain that "break through" the medication used to control the persistent pain, is a common condition for patients with a variety of chronic diseases. 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 programme.
BEMA Fentanyl consists of a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl for application to the buccal (inner lining of cheek) membranes. As previously announced, the efficacy results from the pivotal phase III efficacy trial in patients with breakthrough pain associated with cancer demonstrated that patients treated with BEMA Fentanyl had a significantly greater reduction in pain as early as 15 minutes (the study's primary endpoint) compared to patients treated with placebo. A subsequent safety study demonstrated a good tolerability profile, said the company.
"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," said Dr. Mark A. Sirgo, president and CEO, BDSI. "We believe the results we have seen to date for BEMA Fentanyl support its potential use in helping address an important unmet need for the millions of patients who live with chronic pain conditions and also suffer from these abrupt and intense bouts of breakthrough pain. We are also pleased to have the support of our partner, Meda AB, in initiating this program."
BEMA Fentanyl is a potential treatment for "breakthrough" pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain). BEMA Fentanyl consists of a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl for application to the buccal (inner lining of cheek) membranes. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain.
BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is focused on developing innovative products to treat acute conditions such as pain.