NSYS Therapeutics' SUBSYS™, which uses an Aptar Pharma Sublingual Unit-Dose Spray (UDS) device, has been launched in the USA for breakthrough cancer pain in patients with cancer who are 18 years of age and older and who are already tolerant to opioid therapy.
Louveciennes, France – March 26, 2012 – World leader in the development and manufacturing of alternate route drug delivery devices, Aptar Pharma worked closely with INSYS to develop a unique customized sublingual Unit-Dose Spray (UDS) device for the delivery of SUBSYS™.
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 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 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 unit-dose sublingual spray for fentanyl.
On March 26th 2012, SUBSYS™ will be available in the United States.
Continuous Expansion of Mucosal Systemic Drug Delivery
Estimated at over $2 billion in 2009, the world market for mucosal systemic drug delivery has experienced strong growth in the last 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.
Key Benefits of Aptar Pharma UDS Technology Platform
Aptar Pharma's UDS is the preferred drug delivery technology spray platform when dose accuracy and ease of administration are critical. UDS's 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.
Pierre Carlotti, Vice President Marketing and Communication for Aptar Pharma Prescription Division, stated: "At Aptar Pharma we are extremely pleased with the recent approval of SUBSYS™ which uses a custom designed Sublingual Unit-Dose Spray device. We look forward to the success of SUBSYS™ and INSYS as a serious emerging player in the treatment of breakthrough cancer pain."
Mike Babich, President and CEO for INSYS commented: "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. 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."
SUBSYS™ is a registered trademark of INSYS Therapeutics Inc.
For more information about INSYS, visit www.insysrx.com
About Aptar Pharma
Aptar Pharma is part of the Aptargroup family of companies, along with Aptar Beauty + Home and Aptar Food + Beverage. We create innovative drug delivery systems that meet the evolving needs of biotechnology, healthcare and pharmaceutical companies around the world. We provide our customers with a wide range of delivery technologies and analytical services backed by years of proven expertise. For more information, visit www.aptar.com/pharma
Aptargroup (NYSE: ATR) is headquartered in the US and has manufacturing sites in North America, Europe, Asia and South America. For more information, visit www.aptar.com.
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.
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