Regency Therapeutics Division of Luitpold Pharmaceuticals, US has opted for Aptar Pharma, a world leader in the development and manufacturing of nasal and pulmonary drug delivery devices. The company is now awaiting the approval from the USFDA for its advanced Sprix, a non-opioid nasal spray for pain management which is an Aptar Pharma nasal spray pump.

Aptar Pharma worked closely with Roxro Pharma for over 7 years to develop the nasal delivery device ‘Sprix’. But in December 2010, Roxro was acquired by Luitpold Pharmaceuticals. The newly formed Regency Therapeutics Division of Luitpold launched Sprix which uses an Aptar Pharma nasal spray pump last week and the product is now commercially available.

The nasal device allows ketorolac tromethamine which is a potent Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) to be delivered intra-nasally for adult patients in the short term up to 5 days for the  management of moderate to moderately severe pain that requires analgesia at the opioid level, according to Aptar Pharma.

Ketorolac tromethamine injection is currently widely used in hospitals and was previously marketed in the US 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.

In this new collaboration with Regency Therapeutics, we offered a  customized device, said Pierre Carlotti, vice president Marketing and Communication for Aptar Pharma Prescription Division.

Aptar Pharma’s ‘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 the company’s technical team, Regency Therapeutics’ pump was customized to include an ergonomic nasal actuator designed to be comfortable for all patients. To prevent accidental actuation during transport and storage, the pump is equipped with a safety clip.

“Aptar Pharma’s reputation for performance and quality was an important consideration in our acquisition of Sprix,” said Eric Hohenschuh, sr. manager, Marketing for Regency Therapeutics.

The nasally administered systemic drugs has seen strong growth in the last few years and in 2009, the estimated market size according to Aptar Pharma is over US$ 2 billion.

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’ which markets 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 is now  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 as it is non-invasive, removing any associated needle stick pain or anxiety, stated Aptar Pharma officials.