In previously reported studies, Actiq has been shown to provide rapid onset of pain relief, within five to 10 minutes, a key factor in treating breakthrough pain effectively. Side-effects observed in all studies were those typical of potent opioid analgesics and did not limit the use of Actiq in this patient population. The NDA for Actiq is the first ever to include a breakthrough pain indication and, if approved, Actiq will be the first, and to this point, the only product specifically cleared for this indication. Abbott Laboratories Hospital Products Division manufactures and intends to market Actiq under license from Anesta in the United States. Breakthrough pain is highly prevalent, impacting over 800,000 people in the U.S. alone.
Patients typically have one to four breakthrough pain episodes each day.
These episodes frequently reach maximal intensity in three minutes and have a relatively short duration. Breakthrough pain is often one of the most agonizing, debilitating and difficult to manage symptoms faced by cancer pain patients. Episodes of breakthrough pain, however, are not managed effectively by using and ATC analgesic alone. Currently available short-acting analgesic tablets, capsules and elixirs do not provide rapid pain relief. Clinical Practice Guidelines recommend against the routine use of invasive methods, reserving them primarily for situations when all other means to achieve pain relief have failed.