PHOENIX, AZ--(Mar 26, 2012) - INSYS Therapeutics, Inc. (PINKSHEETS: NEOL) announces the launch of SUBSYS™ (fentanyl sublingual spray) indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients must remain on around-the-clock opioids when taking SUBSYS. SUBSYS is a part of the TIRF REMS Access program (www.TIRFREMSAccess.com).
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. In clinical trials, SUBSYS achieved a mean absolute bioavailability of fentanyl of 76%. 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 1600 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 and CEO Michael Babich added, "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 1/3 of patients being treated for cancer and up to 80% of patients with later stage disease.
About INSYS Therapeutics, Inc.
INSYS Therapeutics, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative products that address chemotherapy-induced nausea and vomiting (CINV), pain management and other central nervous system disorders. We develop new formulations and delivery methods for existing drugs in order to achieve enhanced efficacy, faster onset of action, reduced side effects, convenient delivery and increased patient compliance. Our drug development programs are based on existing compounds with known or proven safety, efficacy and commercialization histories. We are focused on leveraging our expertise in the expanding synthetic cannabinoid derivatives and specialized opioid markets to build a portfolio of proprietary products that address the limitations of existing therapies.