Behandelcentrum Neuropathische Pijn

A Cephalon, Inc. (Nasdaq: CEPH) Phase 3 clinical trial presented today at the 59th Annual Meeting of the American Academy of Neurology in Boston highlights data demonstrating that FENTORA(R) (fentanyl buccal tablet) [C-II] is beneficial for the treatment of breakthrough pain in patients with neuropathic pain who are already taking opioids around-the clock to manage their persistent pain. This study marks the first time an opioid has been evaluated in patients with breakthrough pain associated with chronic neuropathic pain.

"This study provides strong evidence that opioids like FENTORA may be useful in managing breakthrough pain in patients with chronic neuropathic pain," said Dr. David Simpson, Professor of Neurology at Mount Sinai Medical Center and primary author of this study. "With FENTORA, patients experienced statistically significant and clinically meaningful improvements in pain control and expressed a preference for this medication over the opioid they had previously been prescribed to manage their breakthrough pain."

Cephalon is pursuing clinical development of FENTORA in breakthrough pain associated with conditions other than cancer, including chronic neuropathic pain, and expects to file a supplemental New Drug Application this year. FENTORA is not approved for use in these conditions.

The multi-center study evaluated FENTORA in adult patients with chronic neuropathic pain who were diagnosed with a variety of conditions including diabetic peripheral neuropathy, traumatic injury, postherpetic neuralgia and complex regional pain syndrome (CRPS) -- a chronic condition caused by a nerve disorder that occurs at the site of injury, often a fractured arm or leg. All patients were already receiving various around-the-clock opioid medications for persistent pain, and short-acting opioids for their one to four episodes of breakthrough pain a day.

The open label titration phase of the study enrolled 103 patients who were individually titrated to a dose that provided adequate pain relief for at least two of three breakthrough pain flares. Of these, 102 patients received at least 1 dose of FENTORA and 80 patients (78 percent) identified a successful dose with acceptable side effects. Only six patients (6 percent) withdrew from the study due to lack of efficacy. In the randomized, placebo- controlled, double-blind treatment phase in which all patients were exposed to both FENTORA and placebo, data from 75 patients (95 percent of patients who reached a successful dose) were evaluable for efficacy. Key study findings include:

• The primary efficacy measure, the Sum of Pain Intensity Differences from 5 though 60 minutes (SPID60), demonstrated significantly higher scores compared to placebo (9.6 +/- 0.75 vs. 5.7 +/- 0.72, p<0.0001).
• Reduction in pain intensity (PI) and pain relief (PR) was significantly greater with FENTORA than placebo at 10 minutes (p<0.05, p=0.0005, respectively) and maintained throughout the 120 minute evaluation period (p<0.0001 for both PI and PR).
• Significantly more episodes treated with FENTORA showed clinically meaningful reductions in pain intensity (greater or equal to 33 percent reduction at 10 minutes, p=0.008; greater or equal to 50 percent improvement at 15 minutes, p=0.0057). These improvements persisted throughout the 120 minute measurement period (p<0.0001).
• The majority of patients preferred FENTORA over their previous breakthrough pain treatment, rating it good or excellent with respect to onset of action (72 percent), ease of administration (78 percent), and convenience of use (79 percent).
• FENTORA was generally well-tolerated. Adverse events associated with FENTORA in the clinical trial were typical of those seen with opioids, with the exception of mild and transitory application site abnormalities (8 percent). The most common side effects included nausea (13 percent), dizziness (13 percent), drowsiness (10 percent), and vomiting (5 percent). Of the 102 patients included in the safety evaluation, 12 withdrew from the study due to adverse events during the titration phase; none were due to application site abnormalities. There were no reports of respiratory depression or other serious adverse events related to FENTORA in this study.

"This study shows the important role FENTORA can play in the management of breakthrough pain in patients with neuropathic conditions who are already receiving opioids for their persistent pain," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "There is a need to identify additional treatment strategies for this patient population, and these data demonstrate that FENTORA may be an option for breakthrough pain associated with chronic neuropathic pain."

In Nederland is sinds januari 2008 fentanyl voor oromucosaal gebruik  als merkmiddel Actiq® op de markt. De vorm is een zuigtablet met applicator, en de indicatie is de beheersing van doorbraakpijn als gevolg van kanker.  

Maart 2010, prof. dr. Jan M. Keppel Hesselink