Onsolis™ (fentanyl buccal soluble film)
BDSI®'s first application of the lead BEMA® technology is Onsolis® (fentanyl buccal soluble film).
Onsolis® utilizes the BioErodible MucoAdhesive (BEMA®) drug delivery technology, which consists of a small, bioerodible polymer film for application to the buccal membranes (inner lining of the cheek). Onsolis® is an opioid analgesic indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. For additional Onsolis® information including the full prescribing information and medication guide, go to www.onsolis.com. See below for important safety information. For information on the FOCUS™ program, please visit www.onsolisfocus.com.
The global market for pain medication generates annual sales of over $30 billion. Datamonitor estimates the current market for the proposed use of Onsolis® to be approximately $700 million. BDSI® believes that Onsolis® has the potential to capture a significant share of the U.S. market for this use, which is estimated to result in annual peak sales of over $200 million.
Commercialization rights to Onsolis® have been licensed to MEDA for North America and Europe. MEDA is an international specialty pharmaceutical company that concentrates on marketing and market-adapted product development. MEDA is represented in 26 countries and with more than 1,500 employees within marketing and sales. MEDA’s products are sold in approximately 120 countries world-wide.
MEDA PHARMACEUTICALS INC. is the U.S. subsidiary of MEDA. MEDA Pharmaceuticals specializes in central nervous system, respiratory, allergy, and cough-cold products. BDSI® considers MEDA to be an ideal partner and well suited to commercialize Onsolis®. Find out more about MEDA by visiting www.meda.se.
IMPORTANT SAFETY INFORMATION
ONSOLIS is an opioid analgesic indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
ONSOLIS is contraindicated in opioid non-tolerant patients; acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room; and patients with intolerance or hypersensitivity to fentanyl, ONSOLIS, or its components. Life-threatening respiratory depression could occur in patients not taking chronic opiates.
ONSOLIS contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.
Clinically significant respiratory and CNS depression can occur, patients should be monitored accordingly. ONSOLIS films contain medicine in an amount that can be fatal to a child. Keep out of the reach of children and dispose of unneeded films properly. Use with other CNS depressants or CYP3A4 inhibitors may increase depressant effects including hypoventilation (which may lead to potentially fatal respiratory depression), hypotension, and profound sedation; dosage adjustments may be warranted. ONSOLIS may impair ability for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). ONSOLIS should be titrated cautiously in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to hypoventilation. ONSOLIS should be administered with extreme caution in patients susceptible to intracranial effects of CO2 retention.
Substantial differences exist in the pharmacokinetic profile of ONSOLIS compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of ONSOLIS for any other fentanyl product may result in fatal overdose.
The most common adverse reactions (frequency ≥10%) seen in ONSOLIS clinical trials were: nausea, vomiting, dizziness, dehydration, dyspnea, and somnolence.
Safety and efficacy below age 18 years have not been established. ONSOLIS should be administered with caution to patients with renal or hepatic impairment.
ONSOLIS is available only through a restricted distribution program called the FOCUS Program and requires prescriber, pharmacy, and patient enrollment.
Full Prescribing Information for ONSOLIS, including boxed warning, is available at www.onsolis.com or Meda Pharmaceuticals Inc. (1-800-526-3840).