INSYS Therapeutics has announced FDA approval of its branded breakthrough cancer pain medication, SUBSYS fentanyl sublingual spray. SUBSYS is a sublingually-administered formulation of fentanyl in a novel delivery device which offers numerous benefits to patients that experience episodes of breakthrough cancer pain. Breakthrough cancer pain is characterized by sudden, often unpredictable, episodes of intense pain which can peak in severity at three to five minutes despite background pain medication. SUBSYS is approved in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

“INSYS is proud and excited to have SUBSYS approved,” said Dr. Larry Dillaha, MD, Chief Medical Officer of INSYS Therapeutics. “INSYS was founded as a specialty pharmaceutical company with a mission to develop products that meet unmet clinical needs, and to contribute to the improvement of supportive care for cancer patients. Being a single-dose sublingual spray, we believe SUBSYS’ unique and convenient delivery system will offer an important treatment option for appropriate patients.” Dr. Jeffrey A. Gudin of Englewood Hospital and Medical Center, Englewood, NJ, says about SUBSYS: “With the early onset of action, greater bioavailability, and broadest range of approved strengths, SUBSYS is poised to match the onset and intensity of a breakthrough cancer pain episode.” President and CEO Michael Babich added, “I personally would like to thank all the folks who have helped SUBSYS grow from a concept to a commercially approved product. I am so proud of my coworkers, those who participated in the clinical development and the caregivers who realize the need for products providing benefits to their patients whom suffer from breakthrough cancer pain. We intend to continue to grow our commercial organization and launch this product under the recently approved TIRF REMS Access Program when it is launched later this quarter.”