Onsolis (fentanyl buccal)

Company
BioDelivery Sciences

Approval Status
Approved July 2009

Treatment for
breakthrough cancer pain

Areas
Neurology & Nervous System , Cancer & Oncology

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.

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.

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

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.

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

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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