Vitalis Analgesics Announces Publication of Pilot Study Evaluating A Novel Oral Ketamine and Aspirin Formulation for Acute Musculoskeletal Pain

Vitalis Pharmaceuticals

Treatment showed improved pain scores with lower side effects than typically seen with ketamine

Supports evaluation of proprietary VTS-85, an oral formulation of ketamine and aspirin

Published online in Journal of Emergency Medicine (https://doi.org/10.1016/j.jemermed.2022.01.029)

NEW YORK, May 26, 2022 (GLOBE NEWSWIRE) --  Vitalis Analgesics LLC, a specialty pharmaceutical company leveraging its innovative VTS platform to overcome the limitations of existing drugs, today announced the publication of positive results from a pilot study of a novel oral ketamine and aspirin combination in acute musculoskeletal pain. The study was published online in the Journal of Emergency Medicine.

“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 Joseph Habboushe, MD, MBA, inventor of the VTS platform and founder of Vitalis. “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.”

The prospective, open label, single arm, observational study evaluated the analgesic efficacy of a novel combination of ketamine and aspirin formulations, which Vitalis is developing into VTS-85. The study enrolled 25 adult emergency department (ED) patients presenting with acute musculoskeletal pain of 5 or more on a standard 11-point numeric rating scale. Pain scores and adverse events were recorded at 15-, 30-, 60-, 90- and 120-minutes post administration. The primary endpoint of the study was reduction of pain scores at 60 minutes, with secondary outcomes including the need for rescue analgesia and rates of adverse events (AEs) such as sedation and dissociation measured up to 120 minutes post-administration.

Patients experienced a mean reduction in pain score similar to what was previously seen with oral opioids (oxycodone/acetaminophen) and intravenous ketamine in previous studies conducted at the same site and by the same investigators (Table 1).

Table 1. Across study comparison of pain score reductions of simultaneous dosing of oral VTS aspirin and ketamine vs. other pain studies

Analgesic Efficacy	Mean Reduction in Pain Score at 60 min.
Oral VTS aspirin/ketamine	3.8
Oral oxycodone/acetaminophen1	4.0
IV ketamine2,3,4	3.8
Oral ibuprofen5	2.0
Note: Rows are from separate clinical studies, not head-to-head in a single study.

Notably, the pain reduction lasted through the end of the study, increasing to 4.4 points at 120 minutes. Traditionally pain reduction with single dose ketamine lasts approximately an hour, which is why a ketamine drip is often required for sustained analgesia.

While past IV ketamine studies by the same team of investigators reported dissociation and sedation rates of 47-92%, only 4-8% of pilot study patients experienced these side effects, with none being serious AEs (Table 2).

Table 2. Across study comparison of adverse event rates

Adverse Events	Sedation (%)		Dissociation (%)
	Any	Moderate	Any	Moderate
Oral VTS aspirin/ketamine	8	4	4	0
IV push ketamine2, 3	75	54	92	46
IV drip ketamine4	47	17	50	27
Note: Rows are from separate clinical studies, not head-to-head in a single study.

“These results suggest the limitations of oral ketamine may be addressable,” said Dr. Sergey Motov, attending physician, Department of Emergency Medicine, Maimonides Medical Center and principal investigator of the study with more than 10 years of experience conducting pain management research. “If proven in larger controlled trials, this could represent a breakthrough in the treatment of acute pain and a range of other indications. I look forward to continued work with Dr. Habboushe and the Vitalis team as they evaluate the potential of VTS-85 through additional clinical studies.”

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT04702555.

About Vitalis Analgesics LLC

Vitalis Analgesics was spun out of Vitalis Pharmaceuticals to help unlock ketamine’s enormous potential as an oral medication in pain, mood disorders, and more. Ketamine use has been limited by low bioavailability, short duration of action and serious adverse effects. An oral ketamine with favorable side effect and pharmacokinetic profiles may be a breakthrough, opening up life changing treatments for many patients. Since 2012, Vitalis Pharmaceuticals has aimed to leverage its proprietary VTS platform to overcome the limitations of existing drugs and enhance the patient experience across a variety of therapeutic areas. Our goal is to develop patient-centric therapies that improve disease treatment with fewer side effects, and that offer a higher quality of life. For additional information, please visit www.vitalisanalgesics.com.

Contact:

Burns McClellan for Vitalis Analgesics
Lee Roth (Investors) / Robert Flamm, Ph.D. (Media)
212-213-0006
lroth@burnsmc.com / rflamm@burnsmc.com

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