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news.Luitpold Pharmaceuticals’ newly established division Regency Therapeutics and Daiichi Sankyo have launched the US Food and Drug Administration approved SPRIX (ketorolac tromethamine) Nasal Spray for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.
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Originally developed by Roxro Pharma, Sprix is a prescription intranasal formulation of the analgesic ketorolac, a non-steroidal anti-inflammatory drug (NSAID).
The spray is packaged in boxes that comprises of five single day nasal spray bottles.
Each single-day nasal spray bottle is designed to administer precisely metered doses of 100µL (15.75mg) of ketorolac tromethamine per spray and contains sufficient quantity to deliver eight sprays, for a total of 126mg of ketorolac tromethamine.
Sprix will also be marketed to dentists, oral surgeons and periodontists by Luitpold’s Osteohealth division.
Through a pending co-promotion agreement, Daiichi Sankyo will promote Sprix to primary care physicians.
Luitpold president and CEO Mary Jane Helenek said they believe that SPRIX (ketorolac tromethamine) Nasal Spray will be highly complementary to Luitpold’s existing product line and its continuing strategy to diversify product portfolio and further grow US pharmaceutical business.
ROXRO was acquired by Luitpold Pharmaceuticals, a New York based US subsidiary of Daiichi Sankyo.