Regency Therapeutics has announced the initiation of the 18-month AMPED (Acute Management of Pain from the Emergency Department) registry study to compare patient response to Sprix ketorolac tromethamine nasal spray used to treat pain in emergency departments to outcomes for patients prescribe oral narcotics. The study will be conducted in 15 hospitals, including the University of Pennsylvania and the University of Texas MD Anderson Cancer Center, and is expected to enroll 1,000 patients.
Sprix, a non-steroidal anti-inflammatory drug (NSAID), was approved by the FDA in May 2010, and Regency parent company Luitpold Pharmaceuticals acquired the rights to the nasal spray in February 2011 when it bought Roxro Pharma.
University of Pennsylvania Health System Professor and Chairman, Department of Emergency Medicine, Pennsylvania Hospital, Charles Pollack commented, “Moderate to moderately severe pain is one of the most common reasons patients seek care in emergency departments, but emergency department clinicians often do not provide adequate treatment of pain because of ingrained prescribing habits and concerns about the appropriate use of narcotic analgesics. One of the goals of our study is to understand the overall impact of acute pain and its different treatments on patients after they leave the emergency department, including patient satisfaction, quality of life, and back-to-work/normal activities outcomes.”
Luitpold Medical Director David Bregman added, “We are very interested in comparing the response of emergency room patients to Sprix versus narcotics during the management of acute moderate to moderately severe pain. By providing funds to a group of academically oriented emergency medicine physicians to design and carry out this trial, we felt we could obtain high quality information of interest to both of us.”
Read the Regency press release.
