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IV Tramadol May Fill Acute Care Gap in Post-Operative Pain

June 13, 2018
Avenue Therapeutics' Phase 3 data moves opioid alternative forward.

Specialty pharmaceutical company Avenue Therapeutics’ pipeline IV Tramadol may soon fill a gap in acute care between acetaminophen/NSAIDS and narcotics for the management of moderate to moderately severe postoperative pain.

“Currently, surgeons and anesthesiologists treating this patient population use IV acetaminophen / NSAIDs, which are meant for mild to moderate pain and may not satisfactorily alleviate more intense pain, and Schedule II conventional narcotics, such as hydrocodone and oxycodone, which carry a higher risk for abuse and dependence,” explained Avenue’s Chief Medical Officer Scott Reines, MD, PhD.

IV tramadol is already approved for use in Europe, and the company recently completed its first Phase 3   trial in the United States. According to a company release about the multicenter, double-blind, placebo-controlled trial (n = 409), the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 48 hours (SPID48) with a 50 mg IV Tramadol treatment arm compared to placebo was met in patients with moderate to moderately severe postoperative pain following bunionectomy surgery. In addition, the trial met its key secondary endpoints (SPID24, total consumption of rescue medicine, and Patient Global Assessment) and demonstrated a clear dose response.

IV tramadol was well-tolerated with no reports of drug-related serious adverse events in the trial. One subject in the 50 mg IV tramadol arm discontinued due to vomiting. The most common (≥ 5%) adverse events in the 50 mg arm were mild or moderate nausea, vomiting, dizziness, and somnolence.

Avenue, headquartered in New York City, plans to initiate a second pivotal Phase 3 trial of IV tramadol in patients following abdominoplasty surgery in the third quarter of 2018.

If the medication moves forward, Dr. Reines noted a few other benefits: postoperative “patients can conveniently transition to oral tramadol, a Schedule IV controlled substance which carries less potential for abuse and a lower risk of dependence than Schedule II narcotics. Moreover, IV tramadol may also provide a therapeutic option for patients who are contraindicated for NSAIDs, those who cannot tolerate strong opioids and certain elderly and obese patients,” he said. Overall, “Providing patients with an effective, lesser-scheduled pain therapy, such as IV tramadol, post-surgery and then bridging to the widely prescribed oral tramadol after discharge from the hospital or surgical center, may minimize the postoperative use of conventional Schedule II narcotics altogether, and help reduce the amounts of Schedule II opiates in the community,” he said.

 

 

 

Last updated on: June 13, 2018
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