Aptar Pharma's Device Delivers INSYS Therapeutics' Drug


Aptar Pharma recently announced INSYS Therapeutics’ SUBSYS, which uses an Aptar Pharma Sublingual Unit-Dose Spray (UDS) device, has been launched in the US for breakthrough cancer pain in patients who are 18 years of age and older and who are already tolerant to opioid therapy.

SUBSYS (fentanyl) sublingual spray is indicated for the treatment of breakthrough cancer pain (BTCP) in opioid-tolerant adult patients who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Breakthrough Cancer Pain 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 usually well controlled with opioids.

Until now, fentanyl has been available in many dosage forms, including nasal, sublingual dissolving tablets, and oral transmucosal. SUBSYS marks the arrival of the first-ever UDS spray for fentanyl.

Estimated at over $2 billion in 2009, the world market for mucosal systemic drug delivery has experienced strong growth in the past few years. Continued success has been seen in the nasally administered treatment of migraine attacks with Triptans, Butorphanol, and Dihydroergotamine. New types of mucosal treatment have emerged with new product launches, a recent example being an orally sprayed Zolpidem for the treatment of insomnia.

Aptar Pharma’s UDS is the preferred drug delivery technology spray platform when dose accuracy and ease of administration are critical. UDS’ primeless feature offers the patient unique ready-to-use convenience that does not exist with traditional multi-dose spray pumps, which need to be primed prior to first use and sometimes re-primed when used infrequently.

At Aptar Pharma, we are extremely pleased with the recent approval of SUBSYS, which uses a custom designed sublingual UDS device,” said Pierre Carlotti, Vice President Marketing and Communication for Aptar Pharma Prescription Division. “We look forward to the success of SUBSYS and INSYS as a serious emerging player in the treatment of breakthrough cancer pain.”

It is amazing to think that when the SUBSYS project first started, INSYS was a small start-up with just 8 people and a dream,” added Mike Babich, President and CEO for INSYS. “Our initial trust in Aptar Pharma and their collaborative spirit as a delivery and development partner were key in helping to get SUBSYS to market.”

For more information about INSYS, visit www.insysrx.com. For more information about Aptar, visit www.aptar.com/pharma.