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 (Prophylaxis of Gout Flares)

505(b)(2)

 

In-licensed U.S. rights in 2022. Plan to launch in the U.S. by 2024
ELYXYB®
(celecoxib) oral solution (Acute Treatment of Migraine )

505(b)(2)

 

In-licensed U.S. and Canada rights in February 2023. Launched in US in April 2023. Expected 1Q 2024: Acute pain filing
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)(Chronic Neck Pain)

Fast Track

 

2Q 2023: Completed Phase II Trial. Planning to initiate Phase 2/3 trial for neck pain in 2024. 3Q 2022: Received Fast Track for low back pain
SP-104
Delayed Burst Release Low Dose Naltrexone (Fibromyalgia)

Prepare Phase 2 Trial

 

Completed multiple Phase 1 trials.
DrugIndicationStage
ZTlido® (lidocaine topical system) 1.8%(Post-herpetic Neuralgia-PHN, Shingles pain) FDA Approved
GLOPERBA®(colchicine USP) oral solution (Prophylaxis of Gout Flares) FDA Approved
ELYXYB®(celecoxib) oral solution (Acute Treatment of Migraine ) FDA Approved
SP-102(Lumbar Radicular/Sciatica Pain) Phase 3
SP-103Lidocaine Topical System 5.4% (3X)(Chronic Neck Pain) Phase 2
SP-104Delayed Burst Release Low Dose Naltrexone (Fibromyalgia) Phase 1