The active ingredient contained within Bema LA met the company’s expectations in terms of the amount absorbed into the bloodstream. Plasma concentrations (amount of active ingredient in the blood) were well within the levels associated with analgesic activity.
BioDelivery Sciences International (BDSI) now intends to actively explore the scale-up of manufacturing of the product for clinical efficacy and safety studies in patients with acute and chronic pain.
The company declined to disclose the active ingredient in Bema LA in the light of the “promising results, and the competitive nature of the pain field.”
“To our knowledge, Bema LA would be the first long-acting opioid to be delivered by the buccal route, extending the potential of our Bema technology to another class of pain compounds,” said Dr Andrew Finn, executive vice president of clinical development and regulatory affairs for BDSI.
The company said that it believes that the product could potentially generate peak sales of $500 million.