Daiichi Sankyo, Regency Therapeutics launch SPRIX Nasal Spray for severe pain

Regency Therapeutics, a newly established division of Luitpold Pharmaceuticals, Inc., and its co-promotion partner Daiichi Sankyo, Inc., announced today that they have launched SPRIX® (ketorolac tromethamine) Nasal Spray and that it is now commercially available. SPRIX® was approved by the U.S. Food and Drug Administration (FDA) in May 2010 for the short-term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

SPRIX® is a prescription intranasal formulation of the analgesic ketorolac tromethamine injection, a non-steroidal anti-inflammatory drug (NSAID). Ketorolac tromethamine injection is currently widely used in hospitals and was previously marketed in the U.S. as Toradol® by Roche Laboratories. More than 500 million injections have been administered in the U.S. since its introduction in 1990. With the launch of SPRIX®, this potent non-opioid pain reliever is now available in a convenient self-administered intranasal dosage form.

SPRIX® was developed by ROXRO PHARMA, Inc. ROXRO was acquired by Luitpold in December 2010. Luitpold Pharmaceuticals is a New York based U.S. subsidiary of Daiichi Sankyo Co., Ltd. (Corporate Headquarters: Tokyo, Japan).

SPRIX® is supplied in boxes containing five single-day nasal spray bottles. Each single-day nasal spray bottle is designed to administer precisely metered doses of 100 microlitres (15.75 mg) of ketorolac tromethamine per spray and contains sufficient quantity to deliver eight sprays, for a total of 126 mg of ketorolac tromethamine. For adult patients < 65 years of age, the recommended dosage is 31.5 mg (one 15.75 mg spray in each nostril) every six to eight hours. For patients greater than or equal to 65 years of age, renally impaired patients, and patients less than 110 lbs, the recommended dosage is 15.75 mg (one 15.75 mg spray in only one nostril) every six to eight hours.

Mary Jane Helenek, President and CEO of Luitpold said, "We are pleased to be able to provide healthcare professionals with an important new non-opioid analgesic to treat moderate to moderately severe acute pain. We believe that SPRIX® (ketorolac tromethamine) Nasal Spray will be highly complementary to Luitpold's existing product line and our continuing strategy to diversify our product portfolio and further grow our U.S. pharmaceutical business."

Regency Therapeutics' specialty sales force will market SPRIX® to hospitals, emergency medicine treatment centers, surgeons and other specialists. SPRIX® will also be marketed to dentists, oral surgeons and periodontists by Luitpold's Osteohealth division. Through a pending co-promotion agreement, Daiichi Sankyo, Inc. will promote SPRIX® to primary care physicians.

"Given the wide variety of practitioners who prescribe acute pain relievers, we are fortunate that Daiichi Sankyo and Luitpold, another US-based Daiichi Sankyo Group company, can work together to broaden our reach and ensure all of the appropriate healthcare providers are educated about SPRIX®, a well-established, non-narcotic analgesic in a new, intranasal delivery system. SPRIX® provides patients with opioid-level pain relief in a non-opioid compound," said Greg Barrett, Vice President of Marketing, Daiichi Sankyo, Inc.