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National Registry Study Under Way to Evaluate Utility of SPRIX® (ketorolac tromethamine) Nasal Spray for Pain Management

Posted on June 25, 2012

 

SHIRLEY, N.Y., June 25, 2012 /PRNewswire/ -- Regency Therapeutics, a division of Luitpold Pharmaceuticals, Inc., announced today that a national registry has been launched by a group of academic emergency medicine specialists led by Charles Pollack, MA, MD, FAAEM, FACEP, FAHA, Professor and Chairman, Department of Emergency Medicine, Pennsylvania Hospital, University of Pennsylvania Health System. The purpose of the registry is to evaluate patient experience with SPRIX® (ketorolac tromethamine) Nasal Spray, a non-narcotic pain medication, in the management of pain associated with certain medical problems that cause patients to seek medical care in the emergency department.

Outcomes will be compared to those of patients who are prescribed oral narcotics for pain relief. The study, called AMPED (Acute Management of Pain from the Emergency Department), will compare the overall impact—efficacy, safety, economics, and patient satisfaction—of these different approaches to pain management from a patient's perspective. SPRIX® Nasal Spray, the first and only intranasal non-steroidal anti-inflammatory drug (NSAID), was approved by the U.S. Food and Drug Administration (FDA) in May 2010 for the shortâ��term management (up to 5 days) of moderate to moderately severe pain that requires analgesia at the opioid level.

"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," said Dr. Pollack. "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."

More than 12 million people in the United States report using opioid or narcotic pain relievers non-medically(1) and, according to the U.S. Centers for Disease Control and Prevention (CDC), these drugs are involved in more overdose deaths than cocaine and heroin combined.(2) In 2009, the misuse and abuse of prescription painkillers was responsible for more than 397,000 emergency department visits, or 129.4 visits per 100,000 people, nearly twice as many as heroin (~213,000 visits, or 69 visits per 100,000 people).(3) The active ingredient in SPRIX® (ketorolac tromethamine) Nasal Spray is not a narcotic (does not bind to opioid receptors) and is non-addictive. In clinical trials, patients showed no withdrawal symptoms upon cessation of ketorolac treatment.(4)

"We are very interested in comparing the response of emergency room patients to SPRIX® vs. 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," said David Bregman, MD, PhD, Medical Director, Luitpold Pharmaceuticals.

The AMPED study will be led by Dr. Pollack and Knox H. Todd, MD, MPH, FACEP, Professor and Chair of the Department of Emergency Medicine, University of Texas MD Anderson Cancer Center. Joining Drs. Pollack and Todd on the registry's steering committee are emergency medicine physicians Deborah Diercks (UC Davis Medical Center, Sacramento, CA), Sharon Mace (Cleveland Clinic Foundation, Cleveland, OH), and Stephen Thomas (University of Oklahoma, Tulsa), and pharmacist John Fanikos (Brigham and Women's Hospital, Boston, MA). AMPED will be conducted at 15 sites around the nation. Approximately 1,000 patients are expected to be enrolled over an 18-month period. Patients will receive SPRIX® and/or a narcotic for the management of acute pain at the time of discharge. Patients will be followed for five days to evaluate a variety of outcomes, including pain relief, adverse effects, activity/work patterns, healthcare resource utilization, and quality of life measures. The AMPED study will be funded by Regency Therapeutics, and conducted by Radnor Registry Research (St Davids, PA) at the 15 participating emergency departments. The study opens to enrollment next month.

"We designed this registry to help us understand better what the options are for treating pain after discharge from the emergency department and how the way we treat pain impacts the total patient experience as they re-enter their lives," said Dr. Todd. "The emergency department, unfortunately, can be a gateway for the misuse and abuse of narcotics.  As emergency care providers, we need to balance the real need to treat acute pain, but also manage our responsibility to our patients and the community.  Hopefully, this study will help provide us a framework for evaluating alternatives to narcotics for treatment of moderate to moderately severe pain."

Please see Important Safety Information following, including Boxed Warning. For additional information about SPRIX® (ketorolac tromethamine) Nasal Spray please visit www.SPRIX.com.

REFERENCES

(1) U.S. Centers for Disease Control and Prevention (CDC). "Prescription Painkiller Overdoses in the U.S." Accessed 5/15/12. Available at: http://www.cdc.gov/Features/VitalSigns/PainkillerOverdoses/

(2) CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers --- United States, 1999-2008. Morbidity and Mortality Weekly Report (MMWR). November 4, 2011; 60(43):1487-1492. Accessed 5/15/12. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm   

(3) U.S. Substance Abuse & Mental Health Services Administration (SAMHSA). Highlights of the 2009 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits. The DAWN Report. December 28, 2010. Accessed 5/15/12. Available at:  http://www.oas.samhsa.gov/2k10/DAWN034/EDHighlightsHTML.pdf

(4) SPRIX® [package insert]. Shirley, NY: American Regent, Inc; 2011.

Source: PR Newswire