Klaria announces positive results in a pre-clinical, proof-of-concept study with transmucosal oral film of Ketamine and files patent to protect the innovative formulation
Today, Klaria announces positive results in a pre-clinical Proof-of-Concept (PoC) study conducted with Ketamine formulated in the company’s proprietary alginate transmucosal film. With this data, the program is now ready for clinical development. Klaria’s development program will focus on the treatment of acute pain. The company also notes that this formulation of ketamine opens up the possibility of offering treatment-resistant depression patients a more attractive option to the currently marketed nasal spray. Furthermore, Klaria announces that it has filed for patent protection of the new formulation. The filed patent application contains several inventive steps in gaining a stable and functional trans-mucosal film containing ketamine as well as information on the performance of this formulation in preclinical tests.
Since Ketamine has low oral availability, these results confirm that Klaria’s technology can deliver compounds that are poorly orally available directly into the blood stream via the oral mucosa. This validates the company’s strategy of focusing on development of compounds that are only available via injection or nasal spray formulations and where this restriction presents an unmet medical need.
The new formulation promises a superior method of delivery of Ketamine for acute pain patients. Today, Ketamine is commonly used in emergency rescue situations as an acute analgesic for injured patients, but the drug is only available as an injection. In some situations, first responders use the injection solution intra-nasally if vascular access is not possible. Klaria’s oral trans-mucosal film offers the possibility for the use of a simple, compact and lightweight oral film to deliver ketamine through the oral mucosa. This product is an easy to use, non-opioid which can be used in many acute situations such as in emergency medicine as well as in the treatment of cancer related pain. Ketamine is also an attractive option for military applications in which bulky injection kits can be replaced by a small film contained in a simple, light, flat package approximately the size and weight of a business card.
Scott Boyer, Klaria Pharma’s CEO said: “The genesis of the ketamine project arose from discussions with emergency room physicians as well as the United States Military. Non-opiate, non-injectable alternatives to acute trauma-related pain are a high priority for both groups. The results of the study were highly successful with peak ketamine levels in blood appearing quickly, within 3 to 10 minutes. The extent of absorption of ketamine was also encouraging and far exceeded the absorption from the nasal sprays as reported in the literature. This superior performance suggests that we can deliver the right dose quickly, simply and safely - every time. We are grateful to the Medical Technology Enterprise Consortium (MTEC) and the US Army Medical Research and Material Command for the opportunity to establish clear goals for the performance and specifications of this product. For acute trauma, we feel that our formulation has the potential to be of great benefit in both military and civilian settings.”
The patent application is applicable globally and was registered in the UK under application number 1912505.3.
For more information, visit the Klaria Pharma Holding website klaria.com or contact:
Scott Boyer, CEO Klaria Pharma Holding AB (publ)
Tel: +46 8-446 42 99 / +46 730-71 64 62
This is Klaria Pharma Holding AB
Klaria (Klaria Pharma Holding AB) is a Swedish listed pharmaceutical company that develops innovative, rapid-acting products. By combining patented technology of a film that attaches to the oral mucosa and well proven pharmaceuticals, the company has developed a drug distribution concept with many benefits and potential uses. Klaria is listed on Nasdaq First North under the short name KLAR. FNCA Sweden is Certified Advisor (firstname.lastname@example.org, +46(0) 8-528 00 399) for Klaria Pharma Holding AB. For more information, see www.klaria.com.