All 6 pipeline drugs use the same proprietary base to minimize cost and the regulatory pathway.
First Drug Category: Topical NSAIDs (NSAIDs include diclofenac, naproxen and aspirin)
Prescription:
- 1) Topical 2% Diclofenac: First indication, Osteo-Arthritis (OA),
- 2) Topical 2% Diclofenac: 2nd expanded indication, acute musculoskeletal pain, i.e. sprained ankle or tennis elbow (not yet approved for existing formulations)
OTC (Over-the-counter)
- 3) 10% Naproxen for OA and musculoskeletal pain (Oral ALEVE® contains naproxen)
- 4) 1% Diclofenac: SMARTECHS’ 1% Diclofenac gel uses the same gel base as prescription product. In 2020 FDA approved 1% Diclofenac ointment, Voltaren. SMARTECH’S 1% Diclofenac has better penetration than Voltaren, which we believe will translate into better performance.
Drug Category: Topical Delivery to replace a Drug taken orally
- 5) LOW DOSE ASPIRIN: Bayer, 81 mg, low dose oral aspirin can be replaced with a topical low dose aspirin product. In Oct. 2021, a US Task Force recommended the 60+ age group stop taking ORAL low dose aspirin to prevent heart attack, stroke and colorectal cancer because it increases the stomach ulcer risk. This is an opportunity for SMARTECH'S platform technology to topically deliver aspirin to replace oral low dose aspirin without risk of ulcers.
Drug Category: Drug Combinations (Diclofenac and Lidocaine)
- 6) The SMARTECH base can be used to combine multiple APIs. SMARTECHS’ first combination topical product will combine the APSs’ sodium diclofenac and lidocaine.