Aptar Pharma's Nasal Spray Device Chosen For Pain Management

SPRIX (Kétorolac Trométhamine), Nasal Spray, which uses an Aptar Pharma nasal spray pump, is the first non-opioid nasal spray to hit the U.S. market in the field of pain management.

World leader in the development and manufacturing of nasal and pulmonary drug delivery devices, Aptar Pharma worked closely with Roxro Pharma for over 7 years to develop the perfect nasal delivery system for SPRIX.

In December 2010, Roxro was acquired by Luitpold Pharmaceuticals. The newly formed Regency Therapeutics Division of Luitpold launched SPRIX last week and the product is now commercially available.

SPRIX uses an Aptar Pharma nasal spray pump, and is the fi rst systemic non-opioid nasal spray to be approved by the FDA for the U.S. market in the field of pain management.

The Aptar Pharma nasal device allows ketorolac tromethamine (a potent NSAID) to be delivered intranasally to adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. Ketorolac tromethamine injection is currently widely used in hospitals and was previously marketed in the U.S. as Toradol by Roche Laboratories. As a nasal spray, SPRIX is a non-invasive, easy-to-use and rapid-acting treatment. Studies have shown that SPRIX can take effect as quickly as an intramuscular injection, making it a great option for ambulatory pain control.

Systemic drug delivery via the nasal route: a dynamic market
Estimated at over 2 billion US dollars in 2009, the world market for nasally administered systemic drugs has seen strong growth in the last few years. Systemic nasal sprays include such products as Miacalcin (Calcitonin) for osteoporosis; Stimate and Minirin (Desmopressine) for enuresis; Imitrex(Sumatriptan Succinate) and Zomig (Zolmitriptan) for migraine attacks; and opioids for severe pain. Now Regency Therapeutics' SPRIX provides a convenient non-narcotic treatment for the short term management of acute moderate to moderately severe pain for ambulatory patients.

Systemic drug delivery via the nasal route: a proven alternative to injectables
After being delivered into the nasal cavity and initially absorbed by the nasal mucosa, the medication enters the vascular system directly, allowing the active ingredient to take effect rapidly. Systemic drug delivery by the nasal route has several advantages over injection: it is non-invasive, removing any associated needle stick pain or anxiety; it is easy-to-use; and the patient has control over the treatment. These advantages all help to improve patient compliance, making treatment more effective. From a managed care perspective, no medical staff are needed to administer the medication, decreasing administration costs.

The ‘Classic' spray pump – making drug delivery easier and improving patient comfort Aptar Pharma's high-performance ‘Classic' spray pumps are widely used in the Pharma market for both systemic and local applications. For SPRIX, the ‘Classic' modular pump was selected. With the help of Aptar Pharma's technical team, Regency Therapeutics' pump was customized to include an ergonomic nasal actuator designed to be comfortable for all patient populations. To prevent accidental actuation during transport and storage, the pump is equipped with a safety clip.

The ‘Classic' pump's modular system is recognized globally for its comfort and use by patients and physicians alike, not only for its precise dose delivery and spray performance, but also for its safety.

"Aptar Pharma is very excited about this new collaboration with Regency Therapeutics, and we are particularly proud of bringing them a customized device" said Pierre Carlotti, Vice President Marketing and Communication for Aptar Pharma Prescription Division.

"Aptar Pharma's reputation for performance and quality was an important consideration in our acquisition of SPRIX; we look forward to working with Aptar Pharma for many years to come" said Eric Hohenschuh, Sr. Manager, Marketing for Regency Therapeutics.

For more information, visit www.sprix.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.

Aptargroup is headquartered in the US and has manufacturing sites in North America, Europe, Asia and South America.

For more information, visit www.aptar.com

SOURCE: Aptar Pharma