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Fentanyl spray could relieve breakthrough cancer pain in five minutes: Insys

Thursday, March 11, 2010, 16:29 This news item was posted in Clinical Trials category and has 0 Comments so far.

Fentanyl sublingual spray developed by Insys Therapeutics to treat breakthrough cancer pain has been found effective in clinical studies.

Insys Therapeutics has announced positive results from the pivotal phase III efficacy trial. All primary and secondary endpoints were achieved in the study.

Fentanyl sublingual spray is the first product to ever show statistically significant pain relief when measuring the summary of pain intensity difference at five minutesĀ  in a phase III breakthrough cancer pain trial using Fentanyl, the company said in a press release.

Given breakthrough cancer pain’s rapid onset and often peak intensity at three to five minutes, it is vital to provide patients with a faster onset of action.

“The sublingual spray demonstrated very rapid, effective pain relief. Patients began to experience meaningful pain relief within five minutes,” stated Dr. Richard Rauck, a principal investigator in the Phase III study observed.

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, he added.

Many patients may not be able to take other currently available drugs due to difficulty in swallowing, nausea or other gastrointestinal problems.

Breakthrough cancer pain is a common, debilitating feature of chronic pain, seen in approximately 75% of patients with cancer. It is a severe pain flare-up that “breaks through” the relief provided by around-the-clock analgesics.

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.

Fentanyl SL spray single unit dose device is formulated with the opioid narcotic fentanyl for delivery to the oral mucosa.

Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain.

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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