Study to Evaluate Nasal Spray for Pain Management

Study to Evaluate Nasal Spray for Pain Management

Emergency medicine specialists at 15 hospitals around the country are launching a national registry to gather patient feedback on Sprix nasal spray as a non-narcotic alternative for pain management.

Sprix, which is made by Regency Therapeutics, is the first and only nasal spray approved by the Food and Drug Administration for the short term management of moderate to severe pain. The active ingredient in Sprix (ketorolac tromethamine)  is non-narcotic and not addictive, according to the company. The study will compare patient feedback on the effectiveness of Sprix to that of patients who are prescribed oral opioid painkillers.

“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 Charles Pollack, MD, Professor and Chairman, Department of Emergency Medicine, Pennsylvania Hospital, University of Pennsylvania Health System. “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.”

About 1,000 patients are expected to enroll in the 18-month period study. Emergency room patients will receive either Sprix or a narcotic for the management of acute pain at the time of discharge. Patients will be followed for five days to evaluate pain relief, adverse effects, work and activity levels, and their quality of life. The study is being funded by Regency Therapeutics.

“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, Medical Director of Luitpold Pharmaceuticals, the parent company of Regency Therapeutics.

In 2009, the misuse and abuse of prescription painkillers was responsible for more than 397,000 emergency room visits, nearly twice as many as heroin, according to the Centers for Disease Control.

“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,” said Knox H. Todd, MD, Professor and Chair of the Department of Emergency Medicine,UniversityofTexas MD Anderson Cancer Center. “Hopefully, this study will help provide us a framework for evaluating alternatives to narcotics for treatment of moderate to moderately severe pain.”

Sprix is not prescribed for pediatric patients or to treat minor or chronic pain. Use of the nasal spray is not recommended for more than five days. Side effects include nasal discomfort, throat irritation, rash, and hypertension.

Authored by: Pat Anson, Editor