By Pat Anson, PNN Editor

An experimental oral tablet that combines ketamine with aspirin was nearly as effective as an opioid in treating acute pain in emergency room patients, according to the results of a small pilot study.

Ketamine is a non-opioid analgesic that is also used to treat anxiety and depression. The drug is so potent, that it is usually administered by an infusion, injection or nasal spray under strict medical supervision. Some doctors and patients have also found ketamine effective as a treatment for certain chronic pain conditions.

“Ketamine has long been viewed as a highly promising analgesic, but its adverse effect profile, available routes of administration, and short-lasting effects limited its use. Our goal is to overcome all three of these limitations,” says Joseph Habboushe, MD, an emergency room physician and founder of Vitalis Analgesics.

Vitalis has developed a proprietary formulation of aspirin that delivers faster and stronger pain relief than traditional aspirin. The company is working to see if a combination of its aspirin with low-dose ketamine could be used to treat pain.

In the pilot study at Maimonides Medical Center in New York, 25 emergency room patients with acute musculoskeletal pain were given the ketamine-aspirin pill – called VTS-85. After an hour, their pain level scores were reduced an average of 3.8 points, pain relief similar to that of oxycodone-acetaminophen (Percocet) formulations, which reduced pain levels by 4.0 points in previous studies.

Researchers say the pain relief from VTS-85 lasted for two hours, with pain scores dropping an average of 4.4 points. Notably, only 4-8% of patients experienced the dissociation and sedation that is usually experienced when ketamine is administered intravenously.

“The results of this pilot study are highly encouraging, with pain reduction similar to studies using IV ketamine formulations but lasting longer and with lower side effects, and it’s oral,” said Habboushe.

The study findings are published in The Journal of Emergency Medicine.

“If proven in larger controlled trials, this could represent a breakthrough in the treatment of acute pain and a range of other indications,” said lead investigator Sergey Motov, MD, Department of Emergency Medicine, Maimonides Medical Center.

Vitalis has completed a second larger trial on the use of VTS-85 in emergency room patients, but the results have not yet been released. The company is also studying VTS-85 as a treatment for acute headache and postoperative pain. The ketamine-aspirin pill will require a prescription if approved by the FDA.