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Assignees
MemberNovillaNovillaNovilla develops AI-designed localized therapeutics to treat pain and inflammation by targeting specific tissues and minimizing systemic side effects. The company's mission is to transform pain care and reduce opioid-related risks by enabling effective, site-specific treatments. Novilla integrates expertise in drug delivery, chemical thermodynamics, and machine learning to address indications such as gout, diabetic circulatory insufficiency, joint inflammation, muscle spasms, and postoperative pain.
Novilla develops AI-designed localized therapeutics to treat pain and inflammation by targeting specific tissues and minimizing systemic side effects. The company's mission is to transform pain care and reduce opioid-related risks by enabling effective, site-specific treatments. Novilla integrates expertise in drug delivery, chemical thermodynamics, and machine learning to address indications such as gout, diabetic circulatory insufficiency, joint inflammation, muscle spasms, and postoperative pain.
Publication Number
US-12440438-B2
Publication Date
2025-10-14
Expiration Date
Abstract
Disclosed are methods for a novel, counter-intuitive, non-obvious, non-invasive, simple to administer, non-systemic delivery of analgesics through the skin to the DRG and DH area to block and relieve pain in the dermatomal distribution of that particular DRG. This method of pain control provides a non-addictive, inexpensive, simple to use alternative to the present standard of care involving addictive, potentially dangerous opioid therapy.
Core Innovation
The disclosed invention relates to a method of remotely controlling pain in an affected dermatomal area by topical application via paraspinal application of a composition comprising ketorolac or a salt thereof to the skin overlying the dorsal branch of a Dorsal Root Ganglion (DRG) serving the affected dermatomal area. The affected dermatomal area is present in an area of the body remote from the area of the skin to which the composition is applied. The method is described as non-invasive and non-systemic delivery, intended to avoid systemic exposure.
The method non-systemically delivers ketorolac (or salt) through the skin to the perineural space and along the dorsal branches to the DRG and Dorsal Horn (DH). Pain control is achieved by blocking nociceptive transmission to the affected dermatomal area in a dermatomal distribution. The disclosure frames this as local analgesia achieved through perineural access and spread to DRG and dorsal horn synapses.
The disclosure emphasizes ketorolac as a sole active agent in the composition and describes formulation components including skin-penetrating agents and additional agents that may include nitric oxide donors, buffers, preservatives, surfactants, water, mineral oil, squalene, stabilization polymers, and chloride salts. Example embodiments include creams, gels, liquids, lotions, and transdermal patches, and the document states outcomes consistent with reduced serum ketorolac after topical application and improved pain outcomes compared to placebo in provided examples.
Claims Coverage
The relevant independent claim is clm-00001. It includes four inventive features covering the remote dermatomal pain target, paraspinal topical delivery over the dorsal branch of a DRG, ketorolac-based non-systemic delivery through the skin to the perineural space and along dorsal branches to the DRG/DH, and blocking nociceptive transmission to the affected dermatomal area, with ketorolac as the sole active agent and specified formulation components.
Remote dermatomal pain control by paraspinal topical ketorolac application
Topically applying via paraspinal application a composition comprising ketorolac or salt thereof to the skin overlying the dorsal branch of a Dorsal Root Ganglion (DRG) serving the affected dermatomal area, where the affected dermatomal area is remote from the skin area to which the composition is applied.
Non-systemic perineural delivery along dorsal branches to DRG and Dorsal Horn
Non-systemically delivering the ketorolac or salt thereof through the skin to the perineural space and along the dorsal branches to the DRG and Dorsal Horn (DH).
Blocking nociceptive transmission in the affected dermatomal area
Blocking nociceptive transmission to the affected dermatomal area.
Ketorolac as the sole active agent with skin-penetrating agents and additional agents
Providing a composition comprising ketorolac or salt thereof as the sole active agent, at least one skin-penetrating agent, and one or more additional agents selected from the listed group including nitric oxide donor, buffers, preservatives, surfactants, water, mineral oil, squalene, stabilization polymers, and chloride salts, with example embodiments including creams, gels, liquids, lotions, and transdermal patches.
The claim coverage centers on remotely controlling dermatomal pain using paraspinal topical ketorolac (or salt) applied over the dorsal branch of a DRG, followed by non-systemic delivery through the skin to the perineural space and along dorsal branches to the DRG and Dorsal Horn, thereby blocking nociceptive transmission to the affected dermatomal area, with ketorolac as the sole active agent and a specified formulation including skin-penetrating agents and additional agents.
Stated Advantages
Non-systemically delivering ketorolac to achieve local pain control without systemic exposure.
Blocking nociceptive transmission to the affected dermatomal area.
Avoiding limitations and risks associated with opioid analgesics, and addressing limitations of systemic NSAIDs and anesthetics.
Documented Applications
Post-operative pain scenarios.
Back pain associated with disc pathology.
Pain associated with an open wound/ankle injury.
Gout and arthritic pain.
A human case with rapid relief after application over L1.
Rat pain models including hind paw inflammation and Freund's Complete Adjuvant.
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