Pipeline

Phase 1Phase 2Phase 3NDA/MAA FilingApprovedMilestones
ZTlido® (lidocaine topical system) 1.8%
(Post-herpetic Neuralgia-PHN, Shingles pain)

 

Launched October 2018
SP-102
(Lumbar Radicular/Sciatica Pain)

 

Phase 3 trial enrollment completed in 2H 2021
SP-103
Lidocaine Topical System 5.4% (3X)(Acute Low Back Pain)

 

Initiating Phase 2 in 2H 2021
SP-104
Delayed Burst Release Low Dose Naltrexone (Fibromyalgia)

 

Initiating Phase 1 in 2H 2021
DrugIndicationStage
ZTlido® (lidocaine topical system) 1.8%(Post-herpetic Neuralgia-PHN, Shingles pain) Approved
SP-102(Lumbar Radicular/Sciatica Pain) Phase 3
SP-103Lidocaine Topical System 5.4% (3X)(Acute Low Back Pain) Phase 2
SP-104Delayed Burst Release Low Dose Naltrexone (Fibromyalgia) Phase 1