VTS-K: Ketamine + VTS Aspirin
for Clot Prophylaxis & Pain in Postoperative Joint Replacements
VTS-K is being developed with the aim of helping:
to reduce the use and dosage of opioid medications for post-op pain management,
to enable patients to get out of bed more quickly, and
to reduce or eliminate the need for anti-coagulants/blood thinners (many which are self-administered injectables).
The Journal of Arthroplasty survey of 730 active members of the American Association of Hip and Knee Surgeons reports that 59.5% of participating hospitals have instructed that all Medicare TKAs should be scheduled as outpatient procedures.
Potential Value of VTS-K in Postoperative Pain Management
Ketamine is a commonly-used non-opioid anesthetic, currently approved in intra-muscular and intravenous formulations, as well as an intranasal formulation for severe treatment-resistant depression. An oral formulation could represent a compelling alternative to opioids following [joint] surgeries, particularly in the out-patient setting.
The combination of ketamine and VTS-Aspirin alters the pharmacokinetic properties of ketamine and improves its absorption, enabling oral administration, creating the potential for a longer-lasting, steadier effect over time and the ability to deliver a consistent baseline reduction in pain.
The opioid epidemic demands strong,
Initial target indication – Reduction of Pain Following Total Knee Replacement (TKA) Surgery
There are currently approximately 700,000 TKA procedures performed per year in the United States, of which 50,000 are outpatient procedures. Over the next 10 years, the number is projected to increase to 3 million, with 1.5 million outpatient procedures.
The combination of ketamine and VTS-Aspirin has the potential to reduce or eliminate the need for opioids to manage post-operative pain.
Vitalis is planning a proof-of-concept study in TKA patients, which will evaluate total pain scores, total opioid need and other patient-important outcomes.
Postoperative Pain creates significant morbidity in patients. Current effective treatment include opiates which may lead to longer hospital stays (Barletta et al.), may decrease the chance of out-patient surgeries, and can lead to dependence (Morris et al.).
Unfortunately, there are limited alternative non-opioid pain medications with fewer adverse effects (Ramsay 2017).
Post-operative clot prophylaxis requires powerful blood-thinning medication (AAOS VTE Guideline) that can lead to bleeding and often requires the patient to self-administer injectables at home.