Effentora fentanyl effervescent buccal tablet regulatory update

On July 11, Teva sent a letter to EMA informing the agency that the biotech decided to withdraw an application seeking to expand the label of pain drug Effentora fentanyl effervescent buccal tablet to include the treatment of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic persistent pain. Teva said the decision was based on CHMP's view that the proposed indication would mean the introduction of a new treatment paradigm and that data so far are not sufficient to address CHMP's concerns.

CHMP said that at the time of withdrawal it was of the opinion that the benefits of the drug did not outweigh its risks. CHMP said it was concerned about the risk of addiction in non-cancer patients when using the drug long term. The committee was also concerned that patients in the studies submitted to the agency had high levels of background pain and might not have been representative of the intended treatment group, which comprises patients with breakthrough pain but whose background pain is otherwise well controlled by regular opioid treatment. ...