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Onsolis (fentanyl buccal)

Company: BioDelivery Sciences
Approval Status: Approved July 2009
Treatment for: breakthrough cancer pain
Areas: Neurology & Nervous System; Cancer & Oncology

| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |


General Information

Onsolis is an oral transmucosal form of the potent opioid analgesic, fentanyl citrate, a pure opioid agonist whose principal therapeutic action is analgesia. The precise mechanism of the analgesic action is unknown although fentanyl is known to be a mu-opioid receptor agonist. Specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug.

Onsolis is specifically indicated 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. This product must not be used in opioid non-tolerant patients.

Onsolis is supplied as a film (200,,400, 600, 800 or 1200 mcg) intended for application to the buccal mucosa (cheek). It utilizes the BioErodible MucoAdhesive (BEMA) bilayer delivery technology which is comprised of water-soluble polymeric films. Onsolis must be individually dose titrated to determine the most effective and tolerable dose.

Starting Dose:
All patients MUST begin treatment using one 200 mcg Onsolis film. Patients switching from another oral transmucosal fentanyl product must be started on no greater than 200 mcg.

  • If adequate pain relief is not achieved after one 200 mcg film, titrate using multiples of the 200 mcg film until the patient reaches a dose that provides adequate analgesia with tolerable side effects. Do not use more than four of the 200 mcg Onsolis films simultaneously.
  • If adequate pain relief is not achieved after 800 mcg Onsolis (i.e., four 200 mcg films), and the patient has tolerated the 800 mcg dose, treat the next episode by using one 1200 mcg film. Doses above 1200 mcg Onsolis should not be used.
  • Single doses should be separated by at least 2 hours. Onsolis should only be used once per breakthrough cancer pain episode (it should not be redosed within an episode).
  • During any episode of breakthrough cancer pain, if adequate pain relief is not achieved after Onsolis, rescue medication may be used after 30 minutes as directed by a healthcare provider.


Clinical Results

FDA Approval
The FDA approval of Onsolis was based on the results of a double-blind, placebo-controlled, crossover study. The trial enrolled opioid tolerant adult patients experiencing breakthrough cancer pain but otherwise controlled with maintenance doses of opioid medications. Open-label titration identified a successful dose of Onsolis (adequate analgesia with tolerable side effects), within the range of 200 to 1200 mcg. The primary outcome measure, the mean sum of pain intensity differences at 30 minutes (SPID30) for Onsolis-treated episodes was statistically significantly higher than for placebo-treated episodes.


Side Effects

Adverse events associated with the use of Onsolis during dose titration may include, but are not limited to, the following:

  • Nausea
  • Vomiting
  • Dizziness
  • Somnolence

Adverse events associated with the use of Onsolis during long-term treatment (maintenance periods) may include, but are not limited to, the following:

  • Nausea
  • Vomiting
  • Asthenia
  • Dehydration
  • Dyspnea
  • Fatigue
  • Constipation
  • Dizziness
  • Headache


Mechanism of Action

Onsolis is an oral transmucosal form of the potent opioid analgesic, fentanyl citrate, a pure opioid agonist whose principal therapeutic action is analgesia. The precise mechanism of the analgesic action is unknown although fentanyl is known to be a mu-opioid receptor agonist. Specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug.


Literature References

Weinstein SM, Messina J, Xie F Fentanyl buccal tablet for the treatment of breakthrough pain in opioid-tolerant patients with chronic cancer pain: A long-term, open-label safety study. Cancer 2009 Jun 1;115(11):2571-9

Darwish M, Kirby M, Jiang JG, Tracewell W, Robertson P Jr Bioequivalence following buccal and sublingual placement of fentanyl buccal tablet 400 microg in healthy subjects. Clinical Drug Investigation 2008;28(1):1-7

Slatkin NE, Xie F, Messina J, Segal TJ Fentanyl buccal tablet for relief of breakthrough pain in opioid-tolerant patients with cancer-related chronic pain. The Journal of Supportive Oncology 2007 Jul-Aug;5(7):327-34

Blick SK, Wagstaff AJ Fentanyl buccal tablet: in breakthrough pain in opioid-tolerant patients with cancer. Drugs 2006;66(18):2387-93

Portenoy RK, Taylor D, Messina J, Tremmel L A randomized, placebo-controlled study of fentanyl buccal tablet for breakthrough pain in opioid-treated patients with cancer. The Clinical Journal of Pain 2006 Nov-Dec;22(9):805-11

Darwish M, Kirby M, Robertson P Jr, Tracewell W, Jiang JG Pharmacokinetic properties of fentanyl effervescent buccal tablets: a phase I, open-label, crossover study of single-dose 100, 200, 400, and 800 microg in healthy adult volunteers. Clinical Therapeutics 2006 May;28(5):707-14


Additional Information

For additional information regarding Onsolis or breakthrough cancer pain, please visit the Onsolis web page.




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Onsolis Drug Information

The Onsolis drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.





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