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A muscle spasm, also known as a muscle cramp, can cause significant
pain, and can arise from trauma, strain, or stress.
Current topical treatments for muscle spasms such Blue Emu and Theraworks don't treat the spasm, but rather just provide symptomatic relief. At this point, there is no FDA approved topical Anti-Spasmodic Agent on the market.
Currently, Prima has established proof-of-principle in animal studies with the help of following studies:
· Rota Rod Study · Open Field test
· Muscle contraction study after electrical stimulation with and without topical application of PI-111- showing inhibition of muscle spasm.
· Isolated muscle study - showing concentration-dependent relaxation · Anecdotal human exposure data.
· Demonstrated efficacy in a Torticollis patient (chronic neck muscle spasm in infants that causes pain and skeletal deformation).
· Torticollis is an orphan indication, and we can seek orphan drug status for PI-111.
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