Vitalis Analgesics announces the publication of a pilot study

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 release of positive results from a pilot study on a new oral ketamine and combination of aspirin in acute musculoskeletal pain. The study was published online in the Journal of Emergency Medicine.

“The results of this pilot study are very encouraging, with pain reduction similar to studies using IV ketamine formulations but lasting longer and with fewer side effects, and it’s taken orally,” said Joseph Habboushe, MD, MBA, inventor of the VTS platform and founder. by Vitalis. “Ketamine has long been considered a very promising analgesic, but its adverse effect profile, available routes of administration and short duration effects have limited its use. Our goal is to overcome these three 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 recruited 25 adult emergency department (ED) patients with acute musculoskeletal pain of 5 or greater on a standard 11-point numerical rating scale. Pain scores and adverse events were recorded 15, 30, 60, 90 and 120 minutes after administration. The primary endpoint of the study was reduction in pain scores at 60 minutes, with secondary endpoints including the need for rescue analgesia and rates of adverse events (AEs) such as sedation and dissociation measured up to 120 minutes after administration.

Patients experienced a mean reduction in pain score similar to what had been observed previously 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. Cross-study comparison of reductions in pain score of concurrent administration of oral VTS aspirin and ketamine versus other pain studies

Analgesic efficacy Mean reduction in pain score at 60 min.
Oral aspirin/ketamine VTS 3.8
Oxycodone/acetaminophen by mouth1 4.0
ketamine IV2,3,4 3.8
Oral ibuprofen5 2.0
Note: Rows are from separate clinical studies, not head-to-head in a single study.

Notably, the reduction in pain lasted until the end of the study, dropping to 4.4 points at 120 minutes. Traditionally, pain reduction with a single dose of ketamine lasts about an hour, so a ketamine infusion is often required for sustained analgesia.

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

Table 2. Cross-study comparison of adverse event rates

Adverse events Sedation (%) Unbundling (%)
Any Moderate Any Moderate
Oral aspirin/ketamine VTS 8 4 4 0
IV push ketamine2, 3 75 54 92 46
Ketamine drip IV4 47 17 50 27
Note: Rows are from separate clinical studies, not head-to-head in a single study.

“These results suggest that the limitations of oral ketamine can be resolved,” said Dr. Sergey Motov, attending physician, Department of Emergency Medicine, Maimonides Medical Center and the study’s principal investigator with more than 10 years of experience. experience in 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 continuing to work with Dr Habboushe and the team. Vitalis 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 study sites, is available on ClinicalTrials.gov using identifier NCT04702555.

About Vitalis Analgesics LLC

Vitalis Analgesics was created from Vitalis Pharmaceuticals to help unlock the enormous potential of ketamine as an oral medication for pain, mood disorders, and more. The use of ketamine has been limited by poor bioavailability, short duration of action, and serious adverse effects. An oral ketamine with favorable side effects and pharmacokinetic profiles could be a breakthrough, paving the way for 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 improve patient experience in a variety of therapeutic areas. Our goal is to develop patient-centered therapies that improve the treatment of diseases with fewer side effects and that provide a better quality of life. For more information, please visit www.vitalisanalgesics.com.

Contact:

Burns McClellan for Vitalis Painkillers
Lee Roth (Investors) / Robert Flamm, Ph.D. (Media)
212-213-0006
[email protected] / [email protected]

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Jacob L. Thornton