MSK-1001
MSK-1001 is an investigational topical gel that is applied onto a laceration and minimizes the pain associated with injecting a local anesthetic. The proprietary medicine is a sterile formulation of lidocaine, epinephrine, and tetracaine (also known in the medical literature as LET). Pharmacy-compounded versions of LET have been used in emergency departments of many hospitals for the past decade. We believe that many of these pharmacy-compounded LET products lack sterility, consistency, stability, and can be inappropriately multi-dosed and stored. We plan to develop the first FDA-approved LET product that is sterile, safe, efficacious, single-dosed, stable and consistently produced to high standards. Currently, there are no FDA-approved topical dermal analgesic products for minimizing the pain from a laceration.
Recently, there have been 58 deaths and 740 fungal meningitis cases resulting from a tainted injectable steroid that was formulated and mass produced by a single compounding pharmacy. MSK-1001 meets a vital clinical need as it will replace a non-sterile pharmacy compounded product with one that has been clinically tested for safety and efficacy and manufactured to sterile FDA standards.