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"We are excited to complete our Phase 3 program with this third and finalcontrolled study. These data show similar positive outcomes as those withFENTORA in treating breakthrough pain in opioid-tolerant patients with cancer,chronic neuropathic pain, and chronic low-back pain," said Dr. Lesley Russell,Executive Vice President, Worldwide Medical and Regulatory Operations. "Weplan to submit these data to the Food and Drug Administration in the fourthquarter as part of our supplemental New Drug Application."
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About the Study
The double-blind, placebo-controlled, variable dose Phase 3 trial included148 patients. The primary endpoint was the Sum of Pain Intensity Differencesfrom five to 60 minutes (SPID(60)) as assessed after 12 weeks of treatment.SPID(60) is a measure that assesses analgesic efficacy of a pain medicationover the first 60 minutes after treatment. Patients treated with FENTORAshowed a statistically significant improvement on the primary endpoint(p<0.0001) compared with placebo. FENTORA was generally well tolerated by thestudy participants with side effects consistent with those in the currentlyapproved label. The company plans to present the data at a major medicalmeeting in the future.
About Breakthrough Pain
Breakthrough pain is a component of chronic pain that is characterized byits rapid onset, moderate to severe intensity, and relatively short duration.Breakthrough pain has an average onset of three to five minutes and typicallylasts 30 to 60 minutes.
About FENTORA
FENTORA is indicated only for the management of breakthrough pain inpatients with cancer who are already receiving and who are tolerant to opioidtherapy, as described below in the FENTORA label, for their underlyingpersistent cancer pain. FENTORA incorporates a drug delivery system thatgenerates transient changes in pH, which may optimize how well the tabletdissolves and how quickly the medicine passes across the lining of the cheek,or buccal mucosa. Serious adverse events associated with all opioids arerespiratory depression (potentially leading to apnea or respiratory arrest),circulatory depression, hypotension, and shock. All patients should befollowed for symptoms of respiratory depression. The most common (greaterthan or equal to 10 percent) adverse events observed in FENTORA cancerclinical trials were nausea, dizziness, vomiting, fatigue, headache,constipation, anemia, somnolence, and peripheral edema. Most adverse eventswere mild to moderate in severity. No attempt was made to correct forconcomitant use of around-the-clock opioids or cancer-related symptoms. Inaddition, application site reactions were reported in nine percent ofpatients, tended to occur early on treatment, and resulted in treatmentdiscontinuation in only two percent of patients.
FENTORA contains fentanyl, an opioid agonist and a Schedule II controlledsubstance, with an abuse liability similar to other opioid analgesics. FENTORAcan be abused in a manner similar to other opioid agonists, legal or illicit.This should be considered when prescribing or dispensing FENTORA i
