INSYS Therapeutics' SUBSYS, which uses a sublingual Unit-Dose Spray (UDS) device from Aptar Pharma, has been launched in the USA for breakthrough cancer pain management in patients who are 18 years of age and older and who are already tolerant to opioid therapy for their underlying persistent cancer pain.
SUBSYS is a sublingual spray formulation of free fentanyl in a novel single unit-dose delivery device which disperses a fine mist over a broad sublingual area (under the tongue). In clinical trials, SUBSYS achieved a mean absolute bioavailability of fentanyl of 76 percent. SUBSYS reached the primary endpoint of summed pain intensity differences at 30 minutes post treatment (SPID30), as well as all other efficacy assessments (5, 10, 15, 10, 45 and 60 minutes post treatment). SUBSYS is available in 100 mcg through 1,600 mcg doses, and can be administered in seconds.
Dr. Richard Rauck of Carolinas Pain Institute and Wake Forest University, Winston-Salem, NC, says, "I am extremely pleased to see the availability of SUBSYS. The clinical profile with an improved rate and extent of absorption represents a meaningful advancement in the treatment for breakthrough cancer pain. The easy-to-use sublingual spray produces effective, potent and rapid pain relief. It will be a tremendous advantage for our patients who experience breakthrough cancer pain."
President/CEO Michael Babich adds, "We are truly thrilled to launch SUBSYS. This launch represents a significant milestone for INSYS Therapeutics as it is our first branded product to be introduced to the market. We look forward to continuing our commitment of developing and commercializing innovative products in the area of supportive care."
Breakthrough Cancer Pain occurs in patients with cancer and is often defined as a temporary flare in pain that can be quite severe. These flares occur in the context of background pain that is otherwise well-controlled on opioids. Breakthrough Cancer Pain episodes can last anywhere from several seconds to hours with the average episode lasting 30 minutes. Breakthrough Cancer Pain is believed to occur in approximately one third of patients being treated for cancer and up to 80 percent of patients with later stage disease.
Source: INSYS Therapeutics Inc.