Meda launches buccal fentanyl Onsolis to manage cancer pain in US

Onsolis to treat breakthrough cancer pain has been launched in US by Meda Pharmaceuticals Inc.

Onsolis contains the pain drug fentanyl in the form of a buccal soluble film is indicated for the management of breakthrough pain  in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

Onsolis consists of a small, dissolvable, polymer film, formulated with opoid analgesic fentanyl, for application to the inner lining of the cheek.

The efficacy of Onsolis was investigated in a clinical trial in opioid tolerant adult patients experiencing breakthrough cancer pain. Breakthrough cancer pain was defined as a transient flare of moderateto-severe pain occurring in patients with cancer experiencing persistent cancer pain otherwise controlled with maintenance doses of opioid medications including at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour, or an equianalgesic dose of another opioid for 1 week or longer.

All patients were on stable doses of either long-acting oral opioids or transdermal fentanyl for their persistent cancer pain.

A double-blind, placebo-controlled, crossover study was performed in patients with cancer to evaluate the effectiveness of Onsolis for the treatment of breakthrough cancer pain. Open-label titration identified a successful dose of Onsolis, within the range of 200 to 1200 mcg.

A “successful” dose was defined as a dose in which a patient obtained adequate analgesia with tolerable side effects.

In the double-blind efficacy study, patients who identified a successful dose were randomized to a sequence of nine treatments; six with the successful dose of Onsolis and three with placebo.

Onsolis uses an innovative drug delivery technology called BioErodible MucoAdhesive (BEMA), developed by BioDelivery Sciences International, Inc.

“The Onsolis technology differs from existing products used in these patients by virtue of its physical characteristics that enable patients to obtain the pain relief they need in a convenient delivery system,” said Sharon Clarke, President, Meda Pharmaceuticals Inc.

Fentanyl is an odourless, rapid-acting opioid  which depresses central nervous system and respiratory function. It is the most powerful opioid known, with a potency approximately 80 times that of Morphine and 100 times that of Heroin. Fentanyl has an LD50 of 3.1 milligrams per kilogram in rats and 0.03 milligrams per kilogram in monkeys. Several analogues of fentanyl are available, and each differ in terms of potency. Additionally, Fentanyl is classified as a Schedule II drug in the United States due to its high abuse rate.

Onsolis is available through a controlled distribution program called FOCUS (Full Ongoing Commitment to User Safety), the first opioid Risk Evaluation and Management Strategy (REMS) program that provides for prescriber, pharmacy, and patient enrollment for the integrated, coordinated safe use of Onsolis.

The FOCUS Program was designed to meet requirements by the US Food and Drug Administration (FDA) to help ensure appropriate use of Onsolis.

The goal of the FOCUS Program for Onsolis is to lessen the risk of Onsolis overdose, abuse, addiction, and serious complications due to medication errors by: helping to assure proper patient selection, including avoidance of the use of Onsolis in opioid non-tolerant patients; reducing the risk of exposure to Onsolis in persons for whom it was not prescribed, including accidental exposure in children; and training prescribers, pharmacists, and patients about proper dosing and administration.

Meda Pharmaceuticals Inc. is the U.S. subsidiary of Meda AB. Meda Pharmaceuticals specializes in respiratory, allergy, central nervous system, and cough-cold products.
Meda AB is an international specialty pharma company that concentrates on marketing and market-adapted product development.