Successful Clinical Trial News for Fentanyl Sublingual Spray

A unit-dose oral spray could provide quick pain relief for cancer patients. Such an achievement could bring much-needed relief to patients, because breakthrough cancer pain can intensify rapidly within minutes.

INSYS Therapeutics Inc. has announced positive results from the pivotal phase III efficacy trial for patients utilizing the Fentanyl Sublingual Spray (SL Spray) technology to treat breakthrough cancer pain.

"The sublingual spray demonstrated very rapid, effective pain relief," reports Dr. Richard Rauck, a principal investigator in the Phase III study. "Patients began to experience meaningful pain relief within five minutes. This observation was supported by the clinical research findings. To date, no other transmucosal Fentanyl product has produced pain relief this quickly. This early finding is supported with continued pain relief at all subsequent time intervals. An easy-to-use oral spray that can produce effective, potent and very rapid pain relief will be a tremendous advantage for our patients who experience moderate to severe cancer breakthrough pain."

The primary endpoint of the study was to measure the summary of pain intensity difference at thirty minutes (SPID (30)) compared to placebo, the company reports in a press release. "INSYS' SL Spray significantly improved mean SPID (30) scores compared with placebo (p<0.0001). The SL spray significantly improved mean SPID values compared with placebo as early as 5 minutes (p=0.022), while all other endpoints starting at ten minutes showed the p value remaining at or less than 0.0001. All primary and secondary endpoints were achieved in the study, and the drug is the first product to ever show statistically significant pain relief when measuring the summary of pain intensity difference at five minutes (SPID(5)) in a phase III breakthrough cancer pain trial using Fentanyl."

Michael Babich, President and COO of INSYS, adds, "We are delighted to announce today's results as it validates our thesis that a delivery system that can be administered in seconds will be a benefit to patients suffering from this indication. More importantly, the results seen at five minutes will benefit patients and doctors who may struggle to find a product that can work quickly as breakthrough pain's onset is quite rapid. In addition, many patients may not be able to take other currently available drugs due to difficulty in swallowing, nausea or other gastrointestinal problems. Our device and array of strengths (100 to 1600 mcg) will allow patients to be treated at their appropriate titrated level. Finally, we were excited to see that 97% of the patients randomized to the double blind period completed the study, while 92% rolled over to the safety portion."

Breakthrough cancer pain "breaks through" the relief provided by around-the-clock analgesics, the company explains. "Unlike persistent cancer pain, breakthrough cancer pain is generally rapid in onset and can last a couple hours with the average episode averaging thirty minutes. Patients with cancer may experience between two and seven episodes of breakthrough cancer pain a day. It is estimated that over a half-million people in the U.S. with cancer suffer from breakthrough pain, however, only about 25,000 receive a treatment approved for the condition."

INSYS' Fentanyl SL spray provides quick administration of Fentanyl, a potential treatment for breakthrough cancer pain. PMP News has called INSYS to learn more about the single unit-dose device with the opioid narcotic fentanyl for delivery to the oral mucosa.

INSYS Therapeutics Inc. is a biopharmaceutical company focused on developing and commercializing innovative products that address chemotherapy-induced nausea and vomiting (CINV), pain management, and other central nervous system disorders.



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