Scilex has completed enrolling patients in a Phase II clinical trial of triple strength formulation of its pharmacologically validated drug candidate, SP-103, for the treatment of acute low back pain (LBP).
Designed to evaluate the safety and efficacy of SP-103 (5.4%), the placebo-controlled, double-blind, randomised, parallel group, multicentre study enrolled around 80 patients over ten sites in the US.
SP-103 is a non-aqueous formulation which shares the same adhesive drug delivery formulation and manufacturing technology as ZTlido topical product, currently being used for the treatment of LBD.
It delivers a localised dose of lidocaine that is said to be three times the drug load of ZTlido (108mg versus 36mg).
Scilex chief medical officer Dmitri Lissin said: “We are looking forward to analysing the data and making further decisions regarding the potential Phase III programme plans.
“We believe that Scilex is the only company with the technology allowing much higher lidocaine concentration than any other topical lidocaine treatments.
“Higher concentration of a drug per covered area of skin is important for achieving therapeutic response. We are very excited about the potential of SP-103.”
Top line data from the trial is expected in the third quarter of this year.
An estimated 65 million adults in the US are suffering with acute LBP with a total potential global market opportunity reaching $10.0bn by the next three years.