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An opioid-free post-surgical pain relief product

Endura-Kit™ is an opioid and preservative-free local anesthetic compound. Endura-Kit contains three components, which, when combined, mix into lidocaine, tetracaine and epinephrine injection for post-operative pain relief. This combination of three well-known, extremely safe, low toxic compound provides an anesthetic designed to provide an opioid-free post-operative solution.

Endura-Kit™ Benefits

Increased comfort with minimal side effects - Endura-Kit™ is a safe opioid-free compound that allows the reported benefits to provide adequate pain relief to patients.

Opioid-free pain relief - Endura-Kit™ may reduce the risk of any opioid-related side effects and may minimize or reduce the risk of patients developing an opioid tolerance or addiction.

Low-toxicity formula – The Endura-Kit™ low-toxicity formula may be suitable for higher volume dosing to ensure full coverage of the affected nerves or wound area.

A versatile post-operative pain relief solution - Endura-Kit™ may be suitable for a wide variety of procedures and post-operative pain management requirements.

Long-lasting pain relief - Thanks to the safe and low toxic combination formula, Endura-Kit™ may offer a sustainable solution pain management.

Who is Ventis Pharma?

Ventis Pharma Corporation strives to become a world leader in advancing pain management solutions. Our innovative, long-acting, low-toxicity products are designed to reduce surgical pain and treat chronic pain conditions safely and effectively. By making our products cost-effective and available throughout the world, we can improve the quality of life for all patients.

Ventis Pharma has achieved this by developing Endura-Kit™, a safe, long-lasting, low-toxicity, patented anesthesia product. Endura-Kit is cost-efficient and may provide an effective alternative to opioids.

What is Endura-Kit™ Injectable?

(Tetracaine 0.2%, Lidocaine 0.4%, Epinephrine 1:1000)
  • Endura-Kit™ is a local anesthesia compound that offers a solution for non-opioid pain relief. Endura-Kit™ provides ultra-long acting, safe pain relief for post-operative care.

  • Endura-Kit™ contains two components, which, when combined, mixes into a preservative-free, patented local anesthetic compound.

  • Endura-kit™ consists of one preloaded Luer-Lock syringe with an 18g mixing needle containing 0.2ml of Epinephrine 1:1000, and one vial containing 50ml of Tetracaine and Lidocaine. Combining these two components results in a solution of 0.2% Tetracaine and 0.4% Lidocaine with Epinephrine 1:250,000.

  • The maximum recommended dose is 1.5ml/kg IBW. (1)

Endura-Kit™ Application

Endura-Kit™ provides a long-lasting pain management solution for various pain management applications.

The local anesthetic compound may be suitable for a variety of surgical procedures and plane blocks, longer-acting local infiltration anesthesia, and local or regional pain management, apart from surgical procedures.

Due to the dilute concentration of the components, the combined product has low toxicity. This allows for higher volume dosing for volume/plane blocks to ensure full coverage of the affected nerves. (2,3)

About Endura-Kit™

Endura-Kit™ is a novel compound that is extremely safe, and effective and provides opioid-free pain relief for patients after surgery.

The two-part injectable kit contains the following components:

TETRACAINE is an amino-ester class local anesthetic. Clinicians have used it for a variety of purposes in the US since the early 1930s. A 0.2% concentration of Tetracaine is not neurotoxic and produces minimal motor blockade. This allows longer and more complete sensory blockade, which is ideal for post-operative analgesia. Tetracaine is immediately metabolized in contact with blood, ameliorating risks associated with unintentional intravascular injection. This means the substance carries minimal risk. (3)

LIDOCAINE is an amino-amide that was approved as a local anesthetic in the U.S. in 1948. It has a long record of safety and efficacy and is administered millions of times each year in the U.S. It is often administered in formulations combined with Epinephrine. It is both common and effective to combine local anesthetic with different onset times and durations to achieve better performance for patients. (2,8,9)

EPINEPHRINE at the 1;250,000 level, has greater direct alpha-2 effect than traditionally understood vasoconstrictive effects, with similar pharmacodynamics in terms of K+ channel gating effects and trans-compartmental movement of local anesthetic within the neuron. All of this contributes to the observed extended duration of sensory blockade by the combination product.

Why Choose Endura-Kit™?

There is a strong demand for non-opioid pain control after surgery. Endura-Kit™ may provide an effective solution for this by offering patients a safe and effective option for pain relief. (4,5)

The primary goal for adequate pain relief after surgery is to increase the patient’s level of comfort with the least possible side effects. This approach allows for the completion of important tasks such as early ambulation and range of motion. Proper pain relief subsequently results in decreased postoperative complications. (6,7)

The benefits of receiving opioid-free pain relief may lead to patients experiencing little to no risk of developing opioid tolerance or addiction, as well as avoiding any opioid-related side effects. Minimizing opioid use, particularly in the setting of an enhanced recovery after surgery protocol, has been shown to decrease hospital length of stay after numerous procedures. (5,7)

*Endura-Kit is not recommended for topical use or for spinal anesthesia. This product is an off-label use of three long-available and extremely safe anesthetics.

Medications may only be ordered by healthcare providers when it is determined that the product is clinically significant over other commercially available products.

https://www.endurakit.com

info@ventispharma.com

http://www.ventispharma.com


REFERENCES:
  1. Local Anesthetics. Ian K McLeod, MD; Chief Editor: Arlen D Meyers, MD, MBA et al. Updated: Mar 18, 2015. http://emedicine.medscape.com/article/873879-overview#a5.
  2. Epinephrine prolongs duration of subcutaneous infiltration of local anesthesia in a dose- related manner. Correlation with magnitude of vasoconstriction. S Liu , R L Carpenter , A A Chiu, T J McGill, S A Mantell. Regional Anesth. Sep-Oct 1995;20(5):378-84.
  3. Laparoscopic-Guided Transversus Abdominis Plane Block for Colorectal Surgery, Joanne Favuzza, D.O. • Conor P. Delaney, M.D. Dis Colon Rectum 2013; 56: 389–391DOI: 10.1097/DCR.0b013e318280549b © The ASCRS 2013.
  4. The Opioid Epidemic: By the Numbers. http://www.hhs.gov/opioids/
  5. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. Chad M. Brummett, MD, et al. JAMA Surg. Published online April 12, 2017. doi:10.1001/jamasurg.2017.0504.
  6. Benefit and risks of local anesthetics in infants and children. Gunter JB. Paediatric Drugs. 2002;4(10):649-72.
  7. Evidence-based practice supports adopting ERAS protocols. OR Manager Vol. 33 No. 5 May 2017. Brydges G.
  8. On the Mechanism by Which Epinephrine Potentiates Lidocaine's Peripheral Nerve Block Catherine J. Sinnott, B.A. ; Lawrence P. Cogswell, Ph.D. ; Anthony Johnson, B.S. ; Gary R. Strichartz, Ph.D. Anesthesiology January 2003, Vol. 98, 181–188. https://doi.org/10.1097/00000542-200301000-00028 .
  9. Anesthesiology. 1981 Mar;54(3):177-81. Mixtures of local anesthetics are no more toxic than the parent drugs. de Jong RH, Bonin JD.

FDA Disclaimer:

This product has not been evaluated or approved by the FDA.

*Nubratori RX Products are produced and lawfully sold in the USA, under the FDA Structured Product Listing Marketing Category #Cl81659 "Outsourcing Facility Compounded Human Drug Product" (Exempt from Approval Requirements)

*Under the Drug Quality and Security Act of 2013 enacted by Congress human drug products compounded by an outsourcing facility, such as Nubratori RX, are exempt from the following three sections of the FD&C Act: section 505 (21 U.S.C. 355)

  1. Concerning the approval of drugs under new drug applications or abbreviated new drug applications); section 502(f)(l) (21 U.S.C. 352(f)(l).
  2. Concerning the labeling of drugs with adequate directions for use.
  3. Concerning Drug Supply Chain Security Requirements: section 582 (21 U.S.C. 360eee-1)