Pipeline

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

505(b)(2)

 

Launched in the U.S. in October 2018
GLOPERBA®
(colchicine USP) oral solution (Treatment of Gout)

505(b)(2)

 

In-licensed U.S. rights in June 2022. Plan to launch in the U.S. in 2023
SP-102
(Lumbar Radicular/Sciatica Pain)

Fast Track and Pre NDA

 

Results from pivotal Phase 3 trial achieved primary and secondary endpoints
SP-103
Lidocaine Topical System 5.4% (3X)(Acute Low Back Pain)

Fast Track

 

Initiated Phase 2 trial in the second quarter of 2022
SP-104
Delayed Burst Release Low Dose Naltrexone (Fibromyalgia)

Prepare Phase 2 Trial

 

Completed multiple Phase 1 trials. Plan to initiate Phase 2 trials in the Q4-2022
DrugIndicationStage
ZTlido® (lidocaine topical system) 1.8%(Post-herpetic Neuralgia-PHN, Shingles pain) Milestones
GLOPERBA®(colchicine USP) oral solution (Treatment of Gout) Milestones
SP-102(Lumbar Radicular/Sciatica Pain) Phase 3
SP-103Lidocaine Topical System 5.4% (3X)(Acute Low Back Pain) Phase 1
SP-104Delayed Burst Release Low Dose Naltrexone (Fibromyalgia) Phase 2