Provide a set-IT-and-forget-IT copaxone patch for hourly dosing of medication to combat multiple sclerosis

The National Institute of Allergy and Infectious Diseases awarded Transdermal Specialties Global, Inc. $320,863 on July 24, 2026, under the Allergy and Infectious Diseases Research program (CFDA 93.855) to develop a programmed transdermal patch for glatiramer acetate (Copaxone) delivery in the treatment of multiple sclerosis.

The recipient is developing the MS-1 patch, a "set-it-and-forget-it" drug delivery system designed to address limitations of standard subcutaneous injection and passive transdermal patches. The patch will be programmed to deliver prescribed doses of Copaxone according to individual patient treatment regimens, potentially improving patient compliance by eliminating the need for patients to recall dosing schedules and reducing injection-related skin complications including soreness, redness, itching, and dimpling. Preliminary studies support the feasibility of the approach.

Work is performed in Broomall, Pennsylvania. The period of performance runs from July 24, 2026, through June 30, 2027. This Project Grant (R43) award represents Phase I funding, which evaluates the soundness of the technical approach, technological innovation, and commercial potential of the proposed research.

Abstract

Multiple sclerosis (MS) is a chronic autoimmune disease with an increase of nearly 30% in global cases since 2013. The disease primarily affects adults aged 18-50 and is more prevalent in women than in men. MS is characterized by inflammation, demyelination, gliosis, and neuronal loss and leads to vision impairment, numbness and tingling, focal weakness, bladder and bowel dysfunction, and cognitive impairment. The occurrence of MS significantly impacts patients' quality of life by interfering with their daily activities due to fatigue, pain and cognitive issues. The disease is managed by the administration of corticosteroids, plasma exchange, and disease modifying therapies (dmts). Glatiramer acetate (copaxone) is one of the dmts that is administered via the subcutaneous route to reduce the number and severity of relapses. The subcutaneous delivery of the drug presents significant challenges as IT usually requires multiple doses and is associated with skin soreness, redness, itch, or dimpling. Although standard passive skin patches are available to administer drugs through the skin as an alternative to painful injections, these are largely limited in their functionality due to lack of control of the flow rate of the drug, their dependence on low molecular weight skin absorption, and the contamination and degradation of the drug molecules upon interaction with the adhesive on the patch. Transdermal specialties has developed the novel and specialised MS-1™ patch that can be programmed to efficiently and non-invasively deliver a prescribed amount of drug according to the treatment regimen of each MS patient. The "set-IT-and- forget-IT" nature of this transdermal drug delivery system allows better patient compliance as the patient does not need to recall the dosing regimen once they set the patch. Preliminary studies showed that the developed solution can efficiently deliver copaxone, in a franz cell model, while maintaining the integrity and purity of the drug, as observed through high-performance liquid chromatography (hplc). This NIH sbir phase i aims to optime the parameters of the patch for programming the safe delivery of copaxone sufficient for a 24-hour period. The study is expected to validate the optimal patch properties and parameters for ensuring the drug integrity, drug release and shelf life of the patch before clinical validation. This achievement will pave the way for a sbir phase II where the efficacy of the system in delivering copaxone through the skin and reducing relapses in MS patients will be demonstrated in human clinical trials.